DETAILED ACTION
Examiner acknowledges receipt of the reply filed 12/18/2025, in response to the final office action mailed 9/19/2025.
Claims 21, 23, 24, 26, 27, 30, 32, 34, 36, 37, 41, 59-61, 64-66, and 68 are pending. Claims 62 and 63 have been cancelled. Claim 68 is newly added.
Claims 24, 34, 36, and 66 remain withdrawn from further consideration for the reasons made of record.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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/18/2025 has been entered.
Claim Objections- withdrawn
The objection of claims 30, 32, 41, and 63-65 is withdrawn in view of the amendment filed 12/18/2025.
Claim Rejections - 35 USC § 112- withdrawn
The rejection of claims 21, 23, 26, 27, 30, 32, 37, 41, and 59-65 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn in view of the amendment filed 12/18/2025.
The rejection of claims 30, 37, 59, and 60 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph [designated as maintained rejection in the final office action mailed 9/19/2025], is withdrawn in view of the amendment filed 12/18/2025.
The rejection of claims 30, 32, 37, 41, and 59-61 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph [designated as new rejection in the final office action mailed 9/19/2025], is withdrawn in view of the amendment filed 12/18/2025.
The rejection of claims 62 and 63 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, is withdrawn in view of the amendment filed 12/18/2025.
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 Therefore, the objections and rejections have been withdrawn.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 12/18/2025 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 12/18/2025.
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.
Sequence Interpretation/Claim Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising an amino acid sequence of SEQ ID NO: 1” requires only a dipeptide or more within SEQ ID NO: 1, “comprising the amino acid sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with or without additional amino acids at any N-/C-terminal ends or additional nucleotides at 5' /3' ends, “consisting of an amino acid sequence of SEQ ID NO: 1” would encompass any sequence of two or more consecutive amino acids (dipeptide or more) fully contained within SEQ ID NO: 1, and “consisting of the amino acid sequence of SEQ ID NO: 1” would be limited to the sequence of the amino acids as specified by SEQ ID NO: 1, and nothing more or less; "an amino acid selected from the group consisting of SEQ ID NOs: 1, 2 and 3” is any sequence of two or more consecutive amino acids (dipeptide or more) fully contained within SEQ ID NO: 1, 2 or 3; and “the amino acid selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3.
Maintained Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 41 remains/is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. This rejection is maintained from the office action mailed 9/19/2025, but has been amended to reflect claims filed 12/18/2025.
Claim 41 is deemed to further be indefinite because parts A), B) and C) are written in alternative language. The claim recites the claim term “or” three times in the claim. The skilled artisan is not apprised of elements that are encompassed within the claim scope, and those that are excluded from the claim scope. The preamble recites the host cell of claim 21, cell lysate, composition, whole cell composition, dried biomass composition, antimicrobial formulation, or animal foodstuff.
It is unclear from the claim as to which elements (parts A, B, C) go with which elements of the preamble. For example, but not limited to, part C) does not appear to be consistent with the host cell (claim 21) because it is not a lysate, composition, etc. Part B) appears to recite elements for formulation and are foodstuff. It is unclear as to how an edible gel would be consistent with a host cell/cell lysate. Examiner expressly notes that this interpretation is not construed as a composition comprising a host cell /cell lysate- but merely a host cell comprising an edible gel which is encompassed within the instant claim scope.
Claim clarification is required.
Examiner recommends deletion of the first two recitations of “or”, and only keep the last recitation of “or” between parts C and D.
Response to arguments
Applicant traversed the rejection at p. 12 of the reply filed 12/18/2025. Applicant amended the claim to remove “”and/or” and recite “or” between alternative clauses/parts A-D.
Applicant’s arguments and amendment did not clarify:
It is unclear from the claim as to which elements (parts A, B, C) go with which elements of the preamble. For example, but not limited to, part C) does not appear to be consistent with the host cell (claim 21) because it is not a lysate, composition, etc. Part B) appears to recite elements for formulation and animal foodstuff. It is unclear as to how an edible gel would be consistent with a host cell/cell lysate. Examiner expressly notes that this interpretation is not construed as a composition comprising a host cell /cell lysate- but merely a host cell comprising an edible gel which is encompassed within the instant claim scope.
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 9/19/2025, but has been amended to reflect claims filed 12/18/2025.
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 [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. 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.
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. See Ex 3.
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 requests that the rejection be held in abeyance (reply at p. 11).
While a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP 714.02). Until a proper Terminal Disclaimer is filed and approved by the Office, the rejection is maintained.
New Objections and Rejections
Specification- Sequence Compliance
This application is objected to because the peptide sequences in Table 5, pages 181 and 182 are not associated with a sequence identifier (a SEQ ID NO). All sequences longer than ten nucleotides or four amino acids referenced in the specification must include a SEQ ID NO and must be included in the Sequence Listing. See MPEP § 2421-2422. Applicant must amend the specification in response to this office action.
Examiner requests that Applicants review the specification to confirm that all sequences, as required, comply with MPEP § 2421-2422.
Claim Objections- New
Claims 30, 41, 59, and 61 are objected to because of the following informalities:
Claim 30 should be amended to recite “within the host cells” at lines 6 and 8. Compare claim 32 with claim 30.
Claim 41 should be amended to recite “more additional agent(s)
Claim 59 should be amended to recite: “A) c) an optional linker amino acid sequence… SEQ ID NOs: 24-31; ; or C) a combination thereof.
Claim 61 should be amended to recite “endolysin polypeptide has bacterial lytic activity, or combination thereof; optionally”.
Appropriate correction is required.
Examiner Comment
Examiner recommends that claim 41 be split into two separate claims. The claim recites related endpoints parts A-C (an additional agent), and a separate and distinct part D.
Parts A-C could be written in terms: preamble further comprising A); B); C); or a combination thereof.
New dependent claim reciting part D.
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 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, 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.
Claim 23 recites the limitation "said endolysin polypeptides”. There is insufficient antecedent basis for this limitation in the claim. To overcome this rejection, claim 23 should be amended to recite “said two or more different endolysin polypeptides”.
Claim 26 recites the limitation "said endolysin polypeptides”. There is insufficient antecedent basis for this limitation in the claim. Because claim 27 depends from claim 26 and does not clarify the point of confusion, it must also be rejected under 35 USC 112(b). To overcome this rejection, claim 26 should be amended to recite “said two or more different endolysin polypeptides”.
Claim 30 recites the limitation "the endolysin polypeptides”. There is insufficient antecedent basis for this limitation in the claim. To overcome this rejection, claim 30 should be amended to recite “the two or more different endolysin polypeptides”.
Claim 32 recites the limitation "said endolysin polypeptides”. There is insufficient antecedent basis for this limitation in the claim. To overcome this rejection, claim 32 should be amended to recite “said two or more different endolysin polypeptides”.
Claim 41 recites the limitation "the endolysin polypeptides”. There is insufficient antecedent basis for this limitation in the claim. To overcome this rejection, examiner recommends claim 61 be amended to recite “wherein at one least of the two or more different endolysin polypeptides
It is further noted that claim 41 lacks antecedent basis for a “antimicrobial formulation comprising the endolysin polypeptides”. Claim 41 is inconsistent with claim 21. Claim 21 is drawn to a host cell encoding two or more endolysin peptides of the claimed SEQ ID NOs. The claimed endolysin polypeptides remain within the context of/physical relationship of a host cell, e.g., a lysate. In contrast, given the broadest reasonable claim interpretation, the antimicrobial formulation comprising the endolysin polypeptides recited in claim 41 can be construed as encompassing isolated and/or cell-free endolysin polypeptides. Claim 21 does not provide for isolated polypeptides.
Claim 59 recites the limitation "the endolysin polypeptide”. There is insufficient antecedent basis for this limitation in the claim. Because claims 60 depends from claim 59 and does not clarify the point of confusion, it must also be rejected under 35 USC 112(b). Examiner notes that claims 60 also recites “the endolysin polypeptide”.
To overcome this rejection, examiner recommends claim 59 be amended to recite “wherein at one least of the two or more different endolysin polypeptides
The metes and bounds of claim 59 are deemed to be indefinite. The preamble of claim 59 recites “The host cell according to claim 21, 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 algal host cell, or animal foodstuff comprising said host cell, cell lysate, composition, dried biomass, or antimicrobial composition”. The preamble recites multiple iterations of lysates and compositions. The exact metes and bounds of each of the claim limitations are deemed to be indefinite.
To overcome this rejection, examiner recommends that claim 59 be rewritten as an independent claim. It is further recommended that semicolons be used in the claim to separate the distinct claim limitations.
It is further noted that claim 59 lacks antecedent basis for a “composition comprising a population of endolysin polypeptides” and “antimicrobial formulation comprising said endolysin polypeptides”. Claim 59 is inconsistent with claim 21. Claim 21 is drawn to a host cell encoding two or more endolysin peptides of the claimed SEQ ID NOs. The claimed endolysin polypeptides remain within the context of/physical relationship of a host cell, e.g., a lysate. In contrast, given the broadest reasonable claim interpretation, the composition or antimicrobial formulation comprising the endolysin polypeptides recited in claim 59 can be construed as encompassing isolated and/or cell-free endolysin polypeptides. Claim 21 does not provide for isolated polypeptides.
Further regarding claim 60, the preamble of claim 60 recites “The host cell, cell lysate, composition, dried biomass composition, antimicrobial formulation or animal foodstuff according to part B of claim 59”. The preamble of claim 60 is inconsistent with that of claim 59. The preamble of claim 59 is set forth above.
Claim 61 recites the limitation "the endolysin polypeptide”. There is insufficient antecedent basis for this limitation in the claim. To overcome this rejection, examiner recommends claim 61 be amended to recite “wherein at one least of the two or more different endolysin polypeptides
The metes and bounds of claim 61 are deemed to be indefinite. The preamble of claim 61 recites “The host cell according to claim 21, cell lysate thereof, composition thereof, dried biomass composition thereof, antimicrobial formulation thereof, or animal foodstuff thereof”. It is unclear from the claim as to which claim element(s) that “thereof” refers back to. For instance, but not limited to, the claimed composition can refer back to a composition of host cells OR a composition of a cell lysate. The claimed dried biomass composition thereof can refer back a dried biomass composition of a composition [which is indefinite on its own], a dried biomass composition of a cell lysate, OR a dried biomass composition of a host cell. To overcome this rejection, examiner recommends that claim 61 be rewritten as an independent claim. It is further recommended that semicolons be used in the claim to separate the distinct claim limitations.
Claims 64 and 65 are indefinite. The metes and bounds of the claims are unclear because they depend from canceled claim 63.
Claim 64 recites the limitation "the endolysin polypeptide”. There is insufficient antecedent basis for this limitation in the claim. To overcome this rejection, examiner recommends claim 64 be amended to recite “wherein one of the two or more different endolysin polypeptides
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 41 and 59-61 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. This is a new rejection necessitated by the amendment filed 12/18/2025.
Claim 21 is drawn to a host cell comprising a population of nucleic acid molecules encoding an endolysin polypeptide, …
Claims 41 is broader in scope than claim 21. Dependent claim 41 recites: The host cell according to claim 21, cell lysate thereof, composition comprising said host cell, composition comprising a population of endolysin polypeptides thereof, whole-cell composition thereof, … Recitation of cell lysate, composition etc., is deemed to be broader in scope than merely a “a host cell” of claim 21.
Examiner further notes that claim 41 recites “antimicrobial formulation comprising the endolysin polypeptides of said host cell”. Given the broadest reasonable claim interpretation, the limitation “antimicrobial formulation comprising the endolysin polypeptides of said host cell” is construed as reading on a formulation comprising a population of endolysin polypeptides which are isolated/independent of the host cell or cell lysate. This is inconsistent with the scope of claim 21 which encompasses an endolysin polypeptides of the claimed SEQ ID NOs within the context of/physical relationship to a host cell (including cell lysate).
Claims 59 and 60 are broader in scope than claim 21. Dependent claim 59 recites: The host cell according to claim 21, cell lysate thereof, composition comprising said host cell, composition comprising a population of endolysin polypeptides thereof, whole-cell composition thereof, … Recitation of cell lysate, dried biomass, composition etc., is deemed to be broader in scope than merely a “a host cell” of claim 21.
Examiner further notes that claim 59 recites “composition comprising a population of endolysin polypeptides thereof” and “antimicrobial formulation comprising said endolysin polypeptide of said host cell”. Given the broadest reasonable claim interpretation, the limitation “composition comprising a population of endolysin polypeptides thereof” is construed as reading on a composition comprising a population of endolysin polypeptides which are isolated/independent of the host cell or cell lysate. This is inconsistent with the scope of claim 21 which encompasses an endolysin polypeptides of the claimed SEQ ID NOs within the context of/physical relationship to a host cell (including cell lysate). The same is true of the claim limitation antimicrobial formulation comprising said endolysin polypeptide of said host cell”.
Claim 61 is broader in scope than claim 21. Dependent claim 61 recites: The host cell according to claim 21, cell lysate thereof, composition thereof, dried biomass composition thereof, antimicrobial formulation thereof, or animal foodstuff thereof, … Recitation of cell lysate, dried biomass, composition etc., is deemed to be broader in scope than merely a “a host cell” of claim 21.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 21, 23, 26, 27, 30, 32, 37, 41, 59-61, 64, 65, and 68 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural phenomenon without significantly more. Claims 21, 23, 26, 27, 30, 32, 37, 41, 59-61, 64, 65, and 68 recite a naturally occurring product, which is not markedly different from its naturally occurring counterpart. See MPEP §§ 2106 et seq.
Claims 21, 23, 26, 27, 30, 32, 37, 41, 59-61, 64, 65, and 68 are directed to a host cell comprising a population of nucleic acid molecules encoding an endolysin polypeptide, wherein each one of the nucleic acid molecules of the population encodes two or more different endolysin polypeptides, which have both been expressed from said nucleic acid molecules; wherein each endolysin polypeptide comprises an amino acid sequence: wherein the amino acid sequence is 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 host cell comprising a population of nucleic acid molecules encoding an endolysin polypeptide, wherein each one of the nucleic acid molecules of the population encodes two or more different endolysin polypeptides, which have both been expressed from said nucleic acid molecules; wherein each endolysin polypeptide comprises an amino acid sequence: wherein the amino acid sequence is 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 NOs: 1-8 or 11, wherein the N-terminal cell wall peptidoglycan catalytic domain is at least 98% identical to SEQ ID NO: 12-20 or 23, and wherein one of the polypeptides comprises at least 98% identity to SEQ ID NO:1.
As evidenced by Glycosyl hydrolase family 25 [Clostridium perfringens] (NCBI Accession No WP_060670755.1, 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) instant SEQ ID NO:4 has 100% identity with a polypeptide found in Clostridium perfringens.
A Clostridium perfringens bacterial cell is deemed to read on a host cell [bacterial cell] comprising a nucleic acid [genome] encoding endolysin polypeptides of instant SEQ ID NOs:1 and 4.
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/ host cell 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 30, the bacterial cells are whole cells. Regarding claim 32, a dried biomass comprising the Clostridium cells and phage does not significantly amount to more than the judicial exception because it is merely the same organic material, just dried out. Regarding claim 37, Zimmer et al (WO2003066845- previously cited) teach that Clostridium perfringens is a causative agent of food poisoning (e.g., pp. 1-2). The bacterium can be found in the intestinal tract of poultry. This is deemed to read on an animal foodstuff. Claim 41 can read on spoiled food (part C). Dried Clostridium cells can read on part D (powdered form). Regarding claim 59, instant SEQ ID NO:1 encompasses SEQ ID NO:12 at the N-terminus, SEQ ID NO:33 at the C-terminus, and SEQ ID NO:33 at amino acids 186-217 [linker].
In sum, when the relevant steps are analyzed, they weigh against a significant difference. Accordingly, claims 21, 23, 26, 27, 30, 32, 37, 41, 59-61, 64, 65, and 68 are patent ineligible.
Relevant Art not relied upon
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 how 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.
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/KRISTINA M HELLMAN/ Examiner, Art Unit 1654