DETAILED ACTION
Examiner acknowledges receipt of the reply filed 06/04/2026, in response to the non-final office action mailed 3/04/2026.
Claims 21, 23, 24, 26, 27, 30, 32, 34, 36, 37, 41, 59-61, 64-66, and 68 are pending.
Claims 24, 34, 36, and 66 remain withdrawn from further consideration for the reasons made of record.
Claims 21, 23, 26, 27, 30, 32, 37, 41, 59-61, 64, 65, and 68 are being examined on the merits in this office 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 .
Examiner Comment
Examiner notes that Applicant broadened the claim scope in the amendment filed 6/4/82026. Examiner cautions Applicant from broadening the claims in a manner beyond the originally elected claim scope.
Applicant amended claim 21 to recite “A composition”. The preambles of all dependent claims should be amended/corrected to recite “the composition”, and not recite host cell, cell lysate thereof, etc. The claims should be revised for claim language consistency and proper antecedent basis.
Claim Objections- withdrawn
The objection of claims 30, 41, 59, and 61 is withdrawn in view of the amendment filed 6/04/2026.
Specification- withdrawn
The objection to the specification is withdrawn in view of the amendment filed 6/04/2026.
Claim Rejections - 35 USC § 112- withdrawn
The rejection of claim 41 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the amendment filed 6/04/2026.
The rejection of claims 23, 26, 27, 30, 32, 41, 59-61, 64, and 65 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the amendment filed 6/04/2026.
The rejection of claims 41 and 59-61 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, is withdrawn in view of the amendment filed 6/04/2026.
Response to Arguments
Applicant’s amendment and arguments with respect to the above objections and rejections have been fully considered and are persuasive. Therefore, the objections and rejections have been withdrawn.
Applicant's arguments filed 06/04/2026 have been fully considered with respect to the maintained rejections but they are not persuasive.
Upon further consideration, a new ground(s) of rejection is made in view of the amendment filed 06/04/2026.
An action on the merits is set forth herein.
Specification
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Maintained Rejections
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 21, 23, 26, 27, 30, 32, 37, 41, 59-61, 64, 65, and 68 remain/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 18/958214 (hereinafter referred to as “the ‘214 application”). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons. This rejection is maintained from the office action mailed 3/04/2026, but has been amended to reflect claims filed 6/04/2026.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding instant claims 21, 23, 26, 27, 30, 32, 37, 61, and 68, claims 1, 7, and 14 of the ‘214 application recite a feed additive comprising Chlamydomonas reinhardtii [host algal cell] and a C6-C14 fatty acid and the endolysins AMI2phiZP2 and GH25CPFORC3. Examiner notes that endolysin AMI2phiZP2 correlates with instant SEQ ID NO:3. Endolysin GH25CPFORC3 correlates with instant SEQ ID NO:1. This reads on a population of endolysin polypeptides consisting of two or more different endolysin polypeptides. See Example 3. Claims 19 and 20 of the ‘214 application recite a method for preventing bacterial contamination of feed comprising adding a feed additive to an animal feed composition the feed additive comprising Chlamydomonas reinhardtii [algal cell] and a C6-C14 fatty acid. Claims 21-23 of the ‘214 application recite a method for preventing bacterial infection in an animal comprising Chlamydomonas reinhardtii [algal cell] and a C6-C14 fatty acid. The claims further read on a host cell expressing two or more different endolysin polypeptides.
Regarding claim 41, claims 2 and 3 of the ‘214 application teach that the bacterium is present in the form of the dry powder dry flakes. Claims 4 and 15 of the ‘214 application recite that the feed composition further comprises lauric acid and oleic acid. Claim 16 of the ’214 application recites a feed composition comprising the feed additive of claim 1. Claims 17 and 18 of the ‘214 application recite that the feed composition is suitable for administration to poultry or swine, including broilers laying hands and turkeys.
Regarding claims 59, 60, 64, and 65, claim 14 of the ‘214 application recite a feed additive comprising Chlamydomonas reinhardtii [algal cell] and a C6-C14 fatty acid and the endolysins AMI2phiZP2 and GH25CPFORC3. Examiner notes that endolysin AMI2phiZP2 has 100% identity with instant SEQ ID NO:3. Endolysin GH25CPFORC3 has 100% identity with instant SEQ ID NO:1.
Accordingly, claims 1-23 of the ‘214 application anticipate instant claims 21, 23, 26, 27, 30, 32, 37, 41, 59-61, 64, 65, and 68.
Response to Arguments
Applicant traverses the rejection at p. 12 of the reply filed 6/04/2026.
Applicant asserts that the core of the ‘214 application is at the endolysins exhibit synergy with C6-C14 fatty acids. Applicant asserts “this feature clearly distinguishes the claimed subject matter” of the ‘214 application from the instant claims. Applicant further asserts that the “present invention is directed towards a composition or a host cell (which may, or may not, be an algal cell)” whereas the ‘214 application “is limited to a Chlamydomonas reinhardtii cell”. Id.
Examiner has reviewed and considered applicants arguments, but is not persuaded.
The ODP rejection is based on the recited claims of the respective applications. Regardless of the asserted “core feature” of the ‘214 application, the claims of the ‘214 application anticipate the instant claims, for the reasons set forth in the above ODP rejection. It is further noted that instant claim 1 recites a host cell. The claims of the ‘214 application recite the host cell Chlamydomonas reinhardtii cell. Contrary to applicant’s assertions, the ‘214 application is not required under MPEP guidelines to recite more than one host cell.
The rejection is maintained for at least these reasons, and those previously made of record.
Claim Rejections - 35 USC § 101
Embodiments of the claimed compositions read on natural products as set forth herein.
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 21, 41, and 59-61 remain/are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural phenomenon without significantly more. Claims 21, 41, and 59-61 recite a naturally occurring product, which is not markedly different from its naturally occurring counterpart. See MPEP §§ 2106 et seq. This rejection is maintained from the office action mailed 3/04/2026, but has been amended to reflect claims filed 6/04/2026.
The instant claims 21, 41, and 59-61 are directed to a composition comprising (a) a population of endolysin polypeptides consisting of two or more endolysin polypeptides … wherein (a) the population of endolysin polypeptides consists of two or more endolysin polypeptides; or b) each endolysin polypeptide comprises an amino acid sequence at least 98% identical to the amino acid sequence of an N-terminal cell wall peptidoglycan catalytic domain of a Clostridium perfringens bacteriophage endolysin polypeptide of SEQ ID NO: 1, 2, 3, 4, 5, 6, 7, 8 or 11, wherein the N-terminal cell wall peptidoglycan catalytic domain is at least 98% identical to SEQ ID NO: 12, 13, 14, 15, 16, 17, 18, 19, 20 or 23, and wherein the amino acid sequence of one of the two or more different endolysin polypeptides is at least 98% identical to the amino acid sequence of SEQ ID NO: 1.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the following reasons. This judicial exception is not integrated into a practical application because the claimed composition comprises naturally occurring components. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because for the following reasons.
Step 1: Is the claim to a process, machine, manufacture or composition of matter? The instant claims are directed to a statutory patent-eligible subject matter category, a composition of matter.
Step 2a Prong 1: Is the claim directed to a law of nature, a natural phenomenon (Product of nature), or an abstract idea? The claims are directed to a nature-based product: a composition comprising (a) a population of endolysin polypeptides consisting of two or more endolysin polypeptides … wherein (a) the population of the population of endolysin polypeptides consists of two or more endolysin polypeptides; or b) each endolysin polypeptide comprises an amino acid sequence at least 98% identical to the amino acid sequence of an N-terminal cell wall peptidoglycan catalytic domain of a Clostridium perfringens bacteriophage endolysin polypeptide of SEQ ID NO: 1, 2, 3, 4, 5, 6, 7, 8 or 11, wherein the N-terminal cell wall peptidoglycan catalytic domain is at least 98% identical to SEQ ID NO: 12, 13, 14, 15, 16, 17, 18, 19, 20 or 23, and wherein the amino acid sequence of one of the two or more different endolysin polypeptides is at least 98% identical to the amino acid sequence of SEQ ID NO: 1.
The closest naturally-occurring counterpart is the individual nature-based components of the combination. This approach is supported by MPEP § 2106.04(c)(II)(A): "Because there is no counterpart mixture in nature, the closest counterparts to the claimed mixture are the individual components of the mixture, i.e., each naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281"
As evidenced by Glycosyl hydrolase family 25 [Clostridium perfringens] (NCBI Accession No, Jan 2016, 3 pages – previously cited), the glycosyl hydrolase family 25 polypeptide is from Clostridium perfringens and has 100% sequence identity with instant SEQ ID NO:1.
As evidenced by UniProt Accession No. A0A2X3BZE6 (accessed 2/27/2026 at URL uniprot.org/uniprotkb/A0A2X3BZE6.txt- – previously cited) instant SEQ ID NO:4 has 100% identity with a polypeptide found in Clostridium perfringens.
There is no evidence in the claims, specification, or prior art that the endolysin polypeptides are markedly different from the corresponding elements in nature. There is no evidence of structural or functional differences between the claimed nature-based product in the closest naturally-occurring counterpart. Therefore, the claims are directed to a natural phenomenon.
Step 2a Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application? The judicial exception is not integrated into a practical application because the endolysin polypeptides being claimed are naturally occurring. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the following reasons.
Step 2b: Does the claim recite additional elements that amount to significantly more than the judicial exception? The claims, as a whole, do not recite any additional elements that amount to significantly more than the judicial exception. Specifically, the claims do not recite any elements in addition to the natural product. Regarding claim 26, the term “composition” does not impart any further meaningful limitation to the instant claim scope. Regarding claim 41, naturally occurring antibiotics are found in the prior art, e.g. tea tree oil, oregano oil, thyme oil, wintergreen oil, lemon oil, garlic, olive leaf extract, and honey (See generally Ott et al, BioOne 79:50-55 (2008)). Claim 61 recites inherent properties of the claimed endolysin polypeptides.
The claims do not recite any elements that render the composition markedly different in structure from the naturally occurring counterpart. The claims do not recite any elements that amount to anything significantly more than the judicial exception.
In sum, when the relevant steps are analyzed, they weigh against a significant difference. Accordingly, claims 21, 41, and 59-61 are patent ineligible.
Response to Arguments
Applicant traverses the rejection at pp. 13-14 of the reply filed 6/4/2026. Applicant alleges the rejection is based on a “flawed analysis of the technical features of the claims and fails to take account of structural and functional differences between the subject matter of the present claims and naturally occurring products”. Applicant asserts (i) naturally occurring products would not comprise multiple different endolysins simultaneously; (ii) naturally occurring products would not comprise the specific endolysin combinations claimed, let alone recombinant expression of such endolysin combinations; and (iii) synergistic activity is still at least an inherent feature of the claims and such synergistic activity would not be found in nature. Id.
Examiner has reviewed and considered Applicants arguments but is not persuaded.
Markedly different characteristic analysis requires comparing the claimed invention to the naturally-occurring counterpart. When the invention is based on a combination, a comparison to the individual components, may be necessary. MPEP § 2106.04(c)(II)(A) states:
When the nature-based product is a combination produced from multiple components, the closest counterpart may be the individual nature-based components of the combination. For example, assume that applicant claims an inoculant comprising a mixture of bacteria from different species, e.g., some bacteria of species E and some bacteria of species F. Because there is no counterpart mixture in nature, the closest counterparts to the claimed mixture are the individual components of the mixture, i.e., each naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281 (comparing claimed mixture of bacterial species to each species as it occurs in nature); Ambry Genetics, 774F.3d at 760, 113 USPQ2d at 1244 (although claimed as a pair, individual primer molecules were compared to corresponding segments of naturally occurring gene sequence); In re Bhagat, 726 Fed. Appx. 772, 778-79 (Fed. Cir. 2018) (non-precedential) (comparing claimed mixture of lipids with particular lipid profile to "naturally occurring lipid profiles of walnut oil and olive oil"). See subsection II.C
In the instant case, there is no counterpart mixture of the claimed population of two or more endolysin polypeptides but the closest counterparts to the claimed mixture are the individual components of the mixture, e.g., a polypeptide of SEQ ID NO:1 and SEQ ID NO:4.
As noted in MPEP § 2106.04(c)(II)(C)(2), innate features of claimed compositions may be considered insufficient to render a product markedly different from its naturally-occurring counterpart: "Ambry Genetics, 774 F.3d at 760-61, 113 USPQ2d at 1244. In sum, because the characteristics of the claimed primers were innate to naturally occurring DNA, they lacked markedly different characteristics from nature and were thus product of nature exceptions. A similar result was reached in Marden, where the court held a claim to ductile vanadium ineligible, because the "ductility or malleability of vanadium is one of its inherent characteristics and not a characteristic given to it by virtue of a new combination with other materials or which characteristic is brought about by some chemical reaction or agency which changes its inherent characteristics". In re Marden, 47 2d 958, 959, 18 CCPA 1057, 1060, 8 USPQ 347, 349 (CCPA 1931)."
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., synergistic activity) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
For these reasons, the rejection is maintained.
New Objections and Rejections
Claim Objections- New
Claims 21, 23, 26, 30, 32, 37, 41, 59-61, 64, 65, and 68 are objected to because of the following informalities:
Claim 21 recites (a) and (b) twice in the claim, each with different claim limitations. The claim should only recite (a) and (b) with a singular claim limitation. The claim should recite “an antimicrobial composition .. an animal foodstuff”, etc. Claim 21 should be amended to include semicolons to more clearly demarcate the boundaries of the claim limitations.
Claim 21 recites “two or more different endolysin polypeptides”. Lines 3, 6, and 12 should recite consistent claim language.
The preamble of claim 23 refers back to a cell lysate of a population of host cells of claim 21. However, instant claim 21 recites a composition comprising a host cell… It is further noted that claim 21 recites a cell lysate of a host cell.
Claims 26, 32, and 37 each refer back to claim 21. Claim 21 recites a composition a host cell comprising a population of nucleic acids molecules encoding endolysin polypeptide. The claims should be revised for proper claim language dependency.
The preamble of claim 30 should be amended to recite “The [[A]] composition according to claim 30”.
The preambles of dependent claims 41, 59-61, 64, 65, and 68 should be amended to be limited to “the composition” and not recite other elements, e.g., host cell, cell lysate thereof, etc. Applicant amended claim 21 to recite “A composition”. The dependent claims should also be amended for claim consistency and proper antecedent basis.
Claim 59 should be amended to recite
at p. 7, l. 10: “wherein the at least one of the two or more different”
at p. 8, line 2: “19, 20 or 23; [[and]]”.
Claim 59 A) subparts a) and b) should be rearranged to more clearly indicate that the clauses respectively relate to the N- and C- termini of the endolysin polypeptide.
The skilled artisan readily understands that a polypeptide comprises an amino acid sequence.
For instance, amend claim A) a) could be amended to recite:
wherein the N-terminal cell wall peptidoglycan catalytic domain comprises an amino acid sequencethat is at least 98% identical to the amino acid sequence of the N-terminal cell wall peptidoglycan catalytic domain of the Clostridium perfringens bacteriophage endolysin polypeptide of SEQ ID NO: 1, 2, 3, 4, 5, 6, 7, 8 or 11[[,]]; or the amino acid sequence of SEQ ID NO: 12, 13, 14, 15, 16, 17, 18, 19, 20 or 23; [[and]]
Please make similar amendments to the remainder of claim 59.
Claim 60 should be amended to recite “Clostridium perfringens” italicized at ll. 7, 12, and 16. The preamble should further recite “two or more endolysin polypeptides”.
Claim 64 should be amended to recite “wherein one or more of the two or more different endolysin polypeptides comprises an amino acid sequencethat is at least 99% identical to the amino acid sequence of the N-terminal cell wall peptidoglycan catalytic domain of the Clostridium perfringens bacteriophage endolysin polypeptide of SEQ ID NO: 1, 2, 3, 4, 5, 6, 7, 8 or 11.
Claim 65 should be amended to recite “of claim 64, wherein the one or more of the two or more different endolysin polypeptides of [[is]] SEQ ID NO: 1, 2, 3, 4, 5, 6, 7, 8 or 11” for proper dependency from claim 64.
Appropriate correction is required.
Examiner recommends that the claims be rewritten in manner to simply claim language.
New 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.
Claims 21, 23, 26, 27, 30, 32, 37, 41, 59-61, 64, 65, and 68 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. This is a new rejection necessitated by the amendment filed 12/18/2025.
The metes and bounds of claim 21, and claims that depend from it, are deemed to be indefinite.
Claim 21 recites the following:
line 2: population of endolysin polypeptides consisting of two or more different endolysin polypeptides
line 10: population of endolysin polypeptides consists of two or more different endolysin polypeptides
The claim recites both closed language and broader claim language of “or more”. The claim is internally inconsistent and the skilled artisan is not apprised of the proper metes and bounds of the claim.
It is noted that with respect to the host cell at line 3, the claim recites a host cell comprising a population of nucleic acid molecules encoding an endolysin polypeptides polypeptide.
Claim 21 recites (a) and (b) twice in the claim with each instance having a different claim limitation. Furthermore, is it unclear if the wherein clause starting at line 9 is a subset of just (b) [lines 3-8], or if the wherein clause is intended to refer back to both (a) and (b) [lines 2-8].
The same is true of the last wherein clause [lines 17-18]. It is unclear from the claim if this clause at lines 17-18 refers back to (b) at lines 12-16, or if the wherein clause is intended to refer back to both (a) and (b) [at lines 10-16].
Claim 21 further recites:
A composition comprising…
(b) a host cell comprising a population of nucleic acid molecules encoding an endolysin polypeptides polypeptide, a cell lysate of the host cell, a whole-cell composition comprising the host cell, a dried biomass composition comprising the host cell, a lysate thereof, an antimicrobial formulation, or antimicrobial composition comprising the endolysin polypeptides of the host cell, or animal foodstuff comprising the host cell, wherein each one of the nucleic acid molecules of the population of nucleic acid molecules encodes two or more different endolysin polypeptides, which have both been expressed from said nucleic acid molecules;
It is unclear if the underlined “comprising the endolysin polypeptides of the host cell” relates back to the antimicrobial composition and the antimicrobial formulation, or just relates back to the antimicrobial composition.
The claim could be interpreted in different ways. Under a first interpretation, a composition comprising an antimicrobial formulation or antimicrobial composition comprising the endolysin polypeptides of the host cell. [antimicrobial formulation and antimicrobial composition each comprise the endolysin polypeptides]
Under a second interpretation, a composition comprising an antimicrobial formulation [NOT requiring endolysin polypeptides]; or antimicrobial composition comprising the endolysin polypeptides of the host cell [antimicrobial composition requiring endolysin polypeptides]. [only the antimicrobial composition comprises the endolysin polypeptides]
Claim 21 recites 4 different compositions: composition [preamble], whole-cell composition, a dried biomass composition, and antimicrobial composition. The metes and bounds of what distinguishes, for example but not limited to, 1) a composition [preamble] comprising a dried biomass composition comprising the host cell versus 2) a dried biomass composition are not clearly set forth in the claim.
Line 5 recites “a lysate thereof”. It is unclear as to what claim limitation the phrase specifically refers back to. Line 4 of claim 21 recites “a cell lysate of the host cell”. Does applicant intend for the lysate to refer back to the lysate of line 4, or a lysate of any of the limitations recited at lines 3-5.
Claim clarification is required.
The antecedent basis of claim 23 as relating back to claim 21 [as-amended recites a composition] should be clarified. It is further noted that claim 21 as amended, recites a composition comprising a cell lysate of the host cell.
Regarding claim 26, the antecedent basis of claim 26 as relating back to claim 21 [as now amended recites a composition] should be clarified. It is further noted that claim 21 as amended, recites a composition comprising a host cell comprising a population of nucleic acids molecules encoding endolysin polypeptides. In contrast, claim 26 recites that the host cells comprises the two or more different endolysin polypeptides. It is acknowledged that claim 21 recites that the endolysin polypeptides have been expressed from said nucleic acid molecules.
Regarding claims 30, 32, and 37, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
To overcome this rejection, Applicant should amend the claims to recite “wherein X is …” claim language in lieu of “such as”. For instance, claim 30 should be amended to recite “host cells are unicellular algal cells;[[,]] wherein the unicellular algal cells are Chlamydomonas sp.;[[,]] and wherein the Chlamydomonas sp. is Chlamydomonas reinhardtii;[[,]]”. Claims 32 and 37 should be similarly amended.
Claim 32 is similarly rejected as set forth for claims 23 and 26- relating back to the composition of claim 21. Claim 32 recites a dried biomass composition. As amended, claim 21 recites composition comprising a dried biomass composition…
Claim 37 refers to claim 21, but not the composition of claim 21. See related rejections of claims 23 and 26.
Further regarding claim 37 part (v) a dried biomass composition comprising said host cell lysate, or composition. The metes and bounds of the two different compositions recited in part (v) are not clearly set forth in the claim.
Regarding claim 41, the preamble of dependent claim 41 recites both the preamble and part of the body of claim 21. Claim 41 recites “The composition, host cell, cell lysate thereof, composition comprising said host cell, whole-cell composition comprising said host cell, dried biomass composition comprising said host cell, antimicrobial formulation comprising the endolysin polypeptides of said host cell, or animal foodstuff comprising said host cell according to claim 21”. Claim 41 does not clearly set forth the features/elements that distinguish the metes and bounds of the claim limitations. See also parts A, B, and C for antecedent issues.
Claim 41 further recites the limitation "the endolysin polypeptides” at p. 6, ll. 3, 7, and at p. 7, ll. 11. There is insufficient antecedent basis for this limitation in the claim. Amend to recite “two or more”.
Claim 59 is rejected for the same reasons as claim 41. The preamble of claim 59 recites: The composition, host cell, cell lysate thereof, composition comprising said host cell, composition comprising a population of endolysin polypeptides thereof, whole-cell composition thereof, dried biomass composition comprising said host cell, lysate thereof, or composition, antimicrobial formulation comprising said endolysin polypeptide of said host cell, or animal foodstuff comprising said host cell, cell lysate, composition, dried biomass, or antimicrobial composition according to claim 21. Claim 59 does not clearly set forth the features/elements that distinguish the metes and bounds of the claim limitations. Please also note multiple recitations of the terms composition and thereof.
Claim 59 further recites the limitation "the linker sequence” at p. 8, l. 15 and second to last line on p. 8. There is insufficient antecedent basis for this limitation in the claim.
The preamble of claim 60 is rejected for lack of claim language consistency. See related rejections for e.g. claims 41 and 59. Additionally, it unclear as to what exactly intended by the phrase “composition comprising said population of endolysin polypeptides thereof”. The claim should further refer to “two or more endolysin polypeptides”.
Regarding claim 61, the preamble of dependent claim 61 recites both the preamble and part of the body of claim 21. Claim 61 recites “The composition, host cell, cell lysate thereof, composition thereof, dried biomass composition thereof, antimicrobial formulation thereof, or animal foodstuff thereof of claim 21”. The claim recites composition three times. The claim recites thereof five times. It is unclear as to what exactly is intended to referred back to for “thereof”. Claim 61 does not clearly set forth the features/elements that distinguish the metes and bounds of the claim limitations. For instance, it is unclear as to what exactly constitutes a composition of a composition thereof.
Claim clarification is required.
Relevant Art Not Relied Upon
Kazanaviciute et al (U.S. 2020/0068910- earliest effective filing date 3/7/2017) teach a method of preventing or reducing contamination of food with Clostridium, comprising contacting said object with a composition comprising at least one endolysin active against said Clostridium (abstract). SEQ ID NO:2 of Kazanaviciute et al. has 74.6% identity with the endolysin of instant SEQ ID NO:1.
Zimmer et al (WO2003066845- previously cited) teach a nucleic acid encoding an endolysin from a bacteriophage specific for Clostridium perfringens (abstract). The reference further teaches host cells comprising a plasmid encoding the nucleic acid and/or recombinant endolysin protein. Zimmer et al teach use of the endolysin in pharmaceutical composition and food grade products, particularly poultry feed (claims 10, 19-22, pp. 6-8). The host cell is preferably a microbial cell.
The reference does not explicitly teach that the microbial cell is an algal cell, or that the endolysin has the amino acid sequence of SEQ ID NOs:1-8 and 11.
Curtiss et al. (U.S. 2011/0159594- previously cited) teach compositions and methods for degrading the peptidoglycan layer of a bacterial cell wall. The method comprises a. introducing into the bacterium a nucleic acid comprising an inducible promoter operably-linked to a nucleic acid, the nucleic acid encoding a first protein capable of forming a lesion in the cytoplasmic membrane of the bacterium and at least one endolysin protein; and b. inducing the promoter to express both the first protein and the endolysin, wherein the first protein allows the endolysin to degrade the peptidoglycan layer of the cell wall (claim 1, para. [0005]). The endolysin is from a gram positive bacteria (para. [0055]). Nonlimiting examples of bacteriophage include phage of Clostridium (para. [0050]). Gram-negative bacteria can include cyanobacteria (para. [0069]).
The reference does not explicitly teach that the endolysin has the amino acid sequence of SEQ ID NOs:1-8 and 11.
Stoffels et al. (Plant Biotech J 15:1130-1140 (2017)- previously cited) teach bacteriophage endolysin proteins against Streptococcus pneumoniae in the chloroplast of Chlamydomonas reinhardtii (algal host cell) (abstract, pp 1132-1133, 1137-1139). The algal host cell is transformed with a plasmid encoding the endolysin polypeptide. Id. The endolysin is antibacterial (abstract, pp. 1131, 1134-1139).
The reference does not explicitly teach that the endolysin has the amino acid sequence of SEQ ID NOs:1-8 and 11.
Conclusion
No claims are allowed.
Claims 21, 23, 24, 26, 27, 30, 32, 34, 36, 37, 41, 59-61, 64-66, and 68 are pending. Claims 24, 34, 36, and 66 are withdrawn.
Claims 21, 23, 26, 27, 30, 32, 37, 41, 59-61, 64, 65, and 68 are rejected.
Applicant's amendment necessitated the new ground(s) 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.
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/KRISTINA M HELLMAN/ Examiner, Art Unit 1654
/JULIE HA/ Primary Examiner, Art Unit 1654
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