DETAILED ACTION
Claims 1-6, 8, and 10-17 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The rejection of claims 1-5 under 35 U.S.C. 102(a)(1) as being anticipated by GenBank MW590698 (2021, https://www.ncbi.nlm.nih.gov/nuccore/MW590698) is withdrawn in light of Applicant’s filing certified copy of foreign priority document CN2021107606436, filed 5 July 2021, an English translation of it, and a statement that the translation of the certified copy is accurate.
The rejection of claims 12-17 under 35 U.S.C. 102(a)(1) as being anticipated by Luo et al, 2018, Analytica Chimica Acta 1044:147-153) taken with the evidence of GenBank MW590698 (2021, https://www.ncbi.nlm.nih.gov/nuccore/MW590698) is withdrawn in light of Applicant’s amendment to the claims and Applicant’s filing certified copy and translation of foreign priority document CN2021107606436.
Claim Objections
Claims 6 are objected to because of the following informalities:
The objection is repeated for the reasons of record as set forth in the Office action mailed 23 January 2026. Applicant’s arguments filed 8 April 2026 have been fully considered but they are not persuasive.
In claim 6, in line 3, “a” should be deleted.
Response to Arguments
Applicant urges that claim 6 has been amended (response pg 4).
This is not found persuasive because no amendment was made to overcome this objection. The other objections were overcome by Applicant’s amendments.
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 1-5 rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Due to Applicant’s amendment of the claims, the rejection is modified from the rejection set forth in the Office action mailed 23 January 2026. Applicant’s arguments filed 8 April 2026 have been fully considered but they are not persuasive.
Claim 1 recites an isolated antibacterial peptide P104 of SEQ ID NO:1 and claim 3 recites an isolated lysin LysP53 of SEQ ID NO:2. The specification teaches that both of these proteins are from bacteriophage p53 (¶39 and 45). The claims recite the additional element that the peptide has lytic activity and that the protein is isolated. However, lytic activity is an inherent feature of both the proteins is SEQ ID NOs:1 and 2 and “isolated” does not confer to the proteins any structure that differs from the protein in the bacteriophage or the phage in a host cell. Thus, these claims are not directed to significantly more than products of nature.
Claims 2 and 4 recite the additional element that the gene sequences of the proteins are specific nucleic acid sequences. However, these sequences do not confer any additonal structure onto the protein, and merely recites nucleic acids that encode the proteins. Thus, these claims are not directed to significantly more than products of nature.
Claim 5 recites the additional element that primer sequences configured to amplify the nucleotide sequence of the lysin LysP53 are SEQ ID NO:5 and SEQ ID NO:6. However, these sequences do not confer any structure onto the protein, and merely recites primers that amplify a nucleic acid that encodes that encode the protein. Thus, this claim is not directed to significantly more than a product of nature.
Response to Arguments
Applicant urges that the currently amended claims now explicitly recite isolated peptides, lysins, and encoding nucleic acids, which are artificial products and not naturally occurring in the claimed isolated form; the claims are directed to isolated, man-made compositions (response pg 4).
This is not found persuasive. Isolated peptides do not different structurally from the peptides in a phage or a bacterium infected with the phage. “To be sure, [Myriad] found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention” in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589-91, 106 USPQ2d 1972, 1978-79 (2013) which discussed DNA; however, the principles apply to proteins.
The claims are not drawn to man-made compositions; however, chemical synthesis of the peptides would not change their structure or function.
Applicant urges that the antibacterial peptide P104 and the lysin LysP53 of the instant application do not exist in nature as free, independent molecules with autonomous lytic activity; In their natural environment, these sequences are not expressed or present as separate, soluble, functional antimicrobial agents (response pg 4).
This is not found persuasive because isolation does not change the structure of the proteins from as they are in the original phage or in a bacterium infected with the phage.
Applicant urges that they identified, extracted, and either chemically synthesized or recombinantly expressed these specific polypeptides from the phage genome, thereby conferring upon them a broad-spectrum lytic activity that was never disclosed in the prior art; this process of converting a natural genetic blueprint into a man-made, isolated, and functionally distinct product constitutes a "significantly more" technical contribution that transforms the claimed subject matter into patent-eligible compositions of matter (response pg 4-5).
This is not found persuasive. Discovery of property not disclosed in the art does not constitutes a "significantly more" technical contribution that transforms the claimed subject matter into patent-eligible compositions of matter. The broad-spectrum lytic activity is an inherent feature of the proteins of SEQ ID NOs:1 and 2. Cloning or chemically synthesizing a protein does not change the structure of the proteins from as they are in the original phage or in a bacterium infected with the phage.
Applicant urges that in contrast to Myriad, the claimed peptides and lysins are not merely isolated from a natural source, they are chemically synthesized or recombinantly expressed as discrete, purified molecules (response pg 5).
This is not found persuasive. The gene and primers in Myriad were either chemically synthesized or recombinantly expressed. A chemically synthesized or recombinantly expressed version of a naturally occurring product is not automatically eligible because it was created by human ingenuity or intervention. The key to the eligibility is whether the claimed proteins possess markedly different characteristics from any naturally occurring counterpart. Applicant has not shown that the instantly claimed peptides do.
Applicant urges that in nature these sequences exist only as part of a larger bacteriophage genome and do not exist as independent, soluble, functional antimicrobial agents; the act of creating them as isolated, active agents constitutes a technological transformation that removes them from the realm of unpatentable natural products (response pg 5).
This is not found persuasive. Separating a peptide from the original phage or in a bacterium infected with the phage does not change its structure and does not constitute a technological transformation.
Applicant urges that the broad-spectrum lytic activity is not an inherent property of the native bacteriophage p53, which, as shown in Luo, infects only A. baumannii; this newly discovered functionality further distinguishes the claimed products from any natural counterpart (response pg 5).
This is not found persuasive. The ability to infect a bacterial species is determined by phage coat proteins, which interact with membrane proteins of specific bacterial species. Infectivity and lytic activity are not the same thing. The claimed peptides have broad-spectrum lytic activity regardless of whether they are in the original phage, in a bacterium infected with the phage, or in a test tube.
Applicant urges that the claimed peptides are not 'products of nature' because they have been chemically synthesized or recombinantly produced to have a purity and structural independence that does not exist in nature (response pg 5).
This is not found persuasive. Applicant has not provided evidence that the claimed isolated peptides differ structurally from the peptides in a phage or a bacterium infected with the phage. See, e.g., Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244 ("Contrary to Myriad's argument, it makes no difference that the identified gene sequences are synthetically replicated. As the Supreme Court made clear, neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible.").
Applicant’s amendment of the claims has overcome this rejection over claims 12-17.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The rejection is repeated for the reasons of record as set forth in the Office action mailed 23 January 2026. Applicant’s arguments filed 8 April 2026 have been fully considered but they are not persuasive.
Claims 6-9 are drawn to vector pET28a-LysP53 and host cells comprising it.
The specification does not teach the sequence of the insert of the vector and only teaches that it was made by amplification from bacteriophage p53. While bacteriophage p53 was mentioned in the prior art (Luo et al, 2018, Analytica Chimica Acta 1044:147-153), it does not appear to be publicly available. Thus, one of skill in the art would not be able to make pET28a-LysP53.
Claims 10-11 are drawn to a method of preparing LysP53, where the method comprises amplifying the LysP53 gene from bacteriophage p53 and constructing pET28a-LysP53. As bacteriophage p53 does not appear to be publicly available, one of skill in the art would not be able to make pET28a-LysP53 or prepare LysP53 by the recited method.
Since bacteriophage p53 is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the plasmids are not so obtainable or available, a deposit of microorganism containing bacteriophage p53 may satisfy the requirements of 35 USC 112. The specification does not disclose a repeatable process to obtain bacteriophage p53 and it is not apparent if bacteriophage p53 is readily available to the public. Thus, a deposit is required for enablement purposes.
If the deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or a statement by an attorney of record over his or her signature and registration number, or someone empowered to make such a statement, stating that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, and that deposit was accepted under the Budapest Treaty would satisfy the deposit requirement made herein.
If the deposit is not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by statement, affidavit or declaration, or by someone empowered to make the same, or by a statement by an attorney of record over his or her signature and registration number showing that:
(a) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the enforceable life of the patent, whichever is longer; and
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807).
In addition, the identifying information set forth in 37 CFR 1.809(d) should be added to the specification. See 37 CFR 1.801 - 1.809 [MPEP 2401-2411.05] for additional explanation of these requirements.
Response to Arguments
Applicant urges that the specification explicitly discloses an alternative, fully enabled pathway for obtaining the LysP53 gene other than amplification from bacteriophage p53, such as chemical synthesis; the specification does not require the use of bacteriophage p53 as a starting material (response pg 6-7).
This is not found persuasive. While the specification may provide an alternative method for obtaining the LysP53 gene, claims 10-11 specifically recite amplifying the LysP53 gene from bacteriophage p53 (see step S1 of claim 10). Amplifying the LysP53 gene from p53 requires that p53 be available. As bacteriophage p53 does not appear to be publicly available, one of skill in the art would not be able to make pET28a-LysP53 or prepare LysP53 by the recited method.
Applicant urges that the complete gene sequence of bacteriophage P53 has been uploaded to the website of the NCBI with the accession number MW590698 and is publicly available ; hose skilled in the art can obtain the complete lysin LysP53 gene sequence (SEQ ID NO: 4) from the NCBI database and, using routine techniques, synthesize the DNA sequence or the entire LysP53 gene without ever needing to isolate or possess the live bacteriophage (response pg 7).
This is not found persuasive because claims 10-11 require the “live” bacteriophage in step S1 of claim 10. Amplifying the gene from the p53 genome requires the bacteriophage from which the genome can be isolated. Chemical synthesis of a 42916 bp genome is not possible.
Further, the specification does not teach the exact steps needed to make vector pET28a-LysP53. What restriction sites were used to clone the gene? Were any changes made to the sequence of pET28a or the LysP53 gene, for example by the addition of primers or by blunting the ends of the gene for cloning purposes, to get a vector with the exact sequence of pET28a-LysP53?
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 the second paragraph of 35 U.S.C. 112:
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 2, 4-5, and 7 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 that the inventor or a joint inventor, or for pre-AIA the applicant, regards as the invention. Dependent claims are included in all rejections.
Due to Applicant’s amendment of the claims, the rejection is modified from the rejection set forth in the Office action mailed 23 January 2026. Applicant’s arguments filed 8 April 2026 have been fully considered but they are not persuasive.
Claim 2 lacks antecedent basis for the limitation “the gene sequence encoding the antimicrobial peptide P104”.
Claim 4 lacks antecedent basis for the limitation “the gene sequence encoding the lysin LysP53”.
Claim 5 is indefinite in their recitation of “the nucleotide sequence of the lysin LysP53” as lysin LysP53 is a protein.
Claim 5 is drawn to a protein where primer sequences configured to amplify the nucleotide sequence of the protein. It is not clear how the primer sequences are related to the claimed protein, as primers that amplify a nucleotide sequence that encodes it have nothing to do with the protein itself.
Response to Arguments
Applicant urges that the have been amended (response pg ).
This is not found persuasive because the listed rejections were not overcome.
Applicant’s amendments to the claims overcame the previous rejections over claims 6, 8 and 12-17.
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 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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 2, 4-9, 14 and 17 are rejected under 35 U.S.C. 112(d) or 35 U.S.C. 112(pre-AIA ), fourth 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.
The rejection is repeated for the reasons of record as set forth in the Office action mailed 23 January 2026. Applicant’s arguments filed 8 April 2026 have been fully considered but they are not persuasive.
Parent claims 1 and 3 are drawn to an antibacterial peptide P104 of SEQ ID NO:1 and a lysin LysP53 of SEQ ID NO:2, respectively.
Dependent claims 2 and 4 recite the gene sequence of the proteins. However, these gene sequences do not alter the structure of the claimed proteins. Thus, the claims fail to further limit the subject matter of the claims upon which they depend.
Claim 5 is drawn to the protein of claim 4 where primer sequences configured to amplify the nucleotide sequence of the protein. It is not clear how the primer sequences are related to the claimed protein, as primers that amplify a nucleotide sequence that encodes it have nothing to do with the protein itself. Thus, the claim fails to further limit the subject matter of the claim upon which it depends.
Parent claims 12 and 15 are drawn to methods comprising lysing Gram-negative bacteria by applying the P104 of claim 1 or the LysP53 of claim 3, respectively. Dependent claims 14 and 17 are drawn to the methods where the gene sequences of the P104 of claim 1 or the LysP53 of claim 3 are recited. However, the gene sequences that encode these proteins to do alter the P104 of claim 1 or the LysP53 of claim 3. Thus, the claims fail to further limit the subject matter of the claims upon which they depend.
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.
Response to Arguments
Applicant urges that the claims have been amended (response pg 6).
This is not found persuasive because none of the amendments have overcome these rejections.
Claims 12-13 and 15-16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anne R. Kubelik, Ph.D., whose telephone number is (571) 272-0801. The examiner can normally be reached Monday through Friday, 9:00 am - 5:00 pm Eastern.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham, can be reached at (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Anne Kubelik/Primary Examiner, Art Unit 1663
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