DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims Status
Claims 35, 37, 54-64 are pending.
Claims 35 and 58-59 are amended.
Claims 1-34, 36, and 38-53 are cancelled.
Election/Restrictions
Applicant's election with traverse of Group III in the reply filed on 03/04/2025 is acknowledged. The traversal is on the ground(s) that the references US 20140044698 A1 to Sabala, US 20140127168 A1 to Loessner, US 20060100134 A1 to Guo, and Osipovitch et al., "Fusion with a cell wall binding domain renders autolysin LytM a potent anti-Staphylococcus aureus agent," FEMS Microbiology Letters, 2015, either together or separately. Regarding the traversal of inventive group election, applicant’s arguments are not found persuasive. As shown in the Requirement for Restriction/Election filed 11/07/2024, the combination of the above references teach the technical feature shared amongst groups I-IV.
Regarding the traversal of the species election requirement, applicant’s arguments are found persuasive, and the requirement for a species election is WITHDRAWN.
The requirement for the inventive group election is still deemed proper and is therefore made FINAL.
Priority
This application is a 371 of PCT/PL202/05055 filed on 10/13/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/30/32025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
(previous objection, withdrawn) Claim 59 is objected to because of the following informalities: Claim 59 recites “the LssCWT domain side”. Claim 35, from which claim 59 depends, does not recite the term “side”. The examiner suggests claim 59 instead recite “The method according to claim 35, wherein the recombinant polypeptide comprises an attached CPP signal sequence fused to the LssCWT domain directing to the inside of a eukaryotic cell” Appropriate correction is required.
Response to Arguments
Applicant’s arguments, see pg. 6, filed 09/30/20025, with respect to 59 have been fully considered and are persuasive. Applicant has amended the claim. The objection of 09/30/20205 has been withdrawn.
(new objection, necessitated by amendment) Claim 62 is objected to because of the following informalities: Claim 62 recites “administered to mammary gland …”. There is a grammatical error that needs to be corrected. Appropriate correction is required.
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.
(previous rejection, withdrawn) Claims 35, 37, 54-61 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.
Claim 35 recites “wherein the subject is selected form the group comprising human female, cattle…” The use of the term “comprising” is open ended, and therefore, the recited Markush group is also open ended and is per se indefinite. MPEP 2173.05(h) states: If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group "comprising" or "consisting essentially of" the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b). Furthermore, claims dependent upon claim 35 do not resolve this issue. Accordingly, claims 35, 37, 54-61 are rejected.
Response to Arguments
Applicant’s arguments, see pg. 6-7, filed 09/30/2025, with respect to claims 35, 37, 54-61 have been fully considered and are persuasive. Applicant has amended claim 35 to recite “selected from the group consisting of…”. The rejection of 09/30/32025 has been withdrawn.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
(previous rejection, maintained) Claims 35, 37, 54-56 and 61 are rejected under 35 U.S.C. 103 as being unpatentable over Jagielska (cited in IDS filed 07/14/2022), Erskine1 (see form PTO-892 Notice of References Cited), and Gruet2 (see form PTO-892 Notice of References Cited), as evidenced by Uniprot.
Jagielska teaches a recombinant fusion protein useful for treating a Staphylococcus aureus infection, which can cause bovine mastitis in dairy heards (Jagielska, pg. 461, abstract; left column). Jagielska teaches that the fusion protein comprises a LytM enzymatically active domain (LytM_EAD) and a lysostaphin cell wall binding domain (Lss_CBD) (Jagielska, pg. 465, [3]). Jagielska teaches that the LytM_EAD portion of the fusion protein comprises residues 185-316 of UniProt entry O33599 (Jagielska, fig. 1). Jagielska teaches that the Lss_CBD comprises residues 402-493 of UniProt entry P10547 (Jagielska, fig. 1). Jagielska also teaches that the recombinant fusion protein comprises an Lss mutant linker sequence (Jagielska, supplementary fig. S4; pg. 465, [5]). The sequence alignments of the LytM_EAD sequence with instant SEQ ID NO: 1, the Lss_CBD sequence with instant SEQ ID NO: 2, and the Lss mutant linker sequence with instant SEQ ID NO: 3 are shown below.
SEQ ID NO: 1 and LytM_EAD
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504
707
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420
709
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SEQ ID NO: 2 and Lss_CBD
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546
665
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362
686
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SEQ ID NO: 3 and Lss mutant linker sequence
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368
732
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485
729
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As shown above, the LytM_EAD and Lss_CBD taught by Jagielska are 100% identity matches for instant SEQ ID NOs: 1 and 2 respectively. Furthermore, the zinc-coordinating amino acids in the active center of SEQ ID NO: 1 are not changed in the LytM_EAD taught by Jagielska. Additionally, Jagielska teaches that the fusion protein of LytM_EAD and Lss_CBD also comprises an Lss linker sequence 17 amino acid residues in length (Jagielska, fig. 1). Thus, Jagielska teaches the recombinant polypeptide used in the method of claim 35.
Jagielska does not teach a method for in-vivo treatment of mastitis or prevention of developing mastitis in a female mammalian subject caused by Staphylococcus aureus. Jagielska does not teach that the subject is selected from the group comprising human female, cattle, domesticated and wild bovines, cow, goat, sheep, giraffe, gazelle, antelope, sows, mares, cats, and dogs. Jagielska does not teach that the recombinant polypeptide is administered to a mammary gland.
Erskine teaches that intramammary infusions of commercial products that have good activity against gram-positive organisms should be administered to any cow with severe clinical mastitis (Erskine, pg. 8, [4]).
Gruet teaches that pharmaceutical formulations administered to dairy cows via the intramammary route distribute into the aqueous and lipid fractions of the milk (Gruet, pg. 249, [4]).
At the time of filing, it would have been obvious to one of ordinary skill in the art to combine the teachings of Jagielska and Erskine. Specifically, it would have been obvious to use the recombinant fusion protein taught by Jagielska to treat mastitis in female cattle, cows and/or domesticated bovines by injection into the mammary gland as taught by Erskine. One of ordinary skill would have been motivated to combine the teachings of Jagielska and Erskine because Erskine teaches that treatment of intramammary S. aureus infection using β-lactams is difficult due to antibiotic resistance (Erskine, pg. 3, [4]). Additionally, Erskine teaches that the use of antibiotics for treatment involves risks such as the cost of discarding milk and residue (Erskine, pg. 3, [4]). Jagielska teaches that peptidoglycan hydrolase enzymes represent an alternative to conventional antibiotics (Jagielska, pg. 461, [2]). Furthemore, Jagielska cites the teachings of Gruet in citation number 2 of their disclosure (Jagielska, pg. 468, citation 2). A person of ordinary skill in the art would have a reasonable expectation of success in combining the above teachings because Jagielska teaches that the recombinant fusion protein has activity against Staphylococcus strains, including MRSA (Jagielska, pg. 466, [2]). Furthermore, Eskrine teaches that the success rate of therapy for chronic intramammary infection caused by S. aureus may be increased by using both parenteral and intramammary therapy (Erskine, pg. 3, [5]). Therefore, it would have been obvious to combine the above teachings of Jagielska and Erskine. Furthermore, claim 35 recites the following functional limitations:
“wherein the recombinant polypeptide exhibits bacteriolytic activity in raw milk”.
“wherein the recombinant polypeptide is administered to a mammary gland and exhibits bacteriolytic activity in raw milk in the mammary gland”.
The recombinant polypeptide taught by Jagielska is substantially identical to the recombinant polypeptide used in the method of claim 35, which is shown above in the sequence alignments. MPEP section 2112.01 states “where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products does not necessarily possess the characteristics of the claimed product.” Because the recombinant polypeptide taught by Jagielska is substantially identical to the recombinant polypeptide used in claim 35, the bacteriolytic activity in raw milk and/or serum appears to be an inherent characteristic that necessarily flows from the recombinant polypeptide taught by Jagielska. Furthermore, regarding claim 37, Gruet teaches that pharmaceutical formulations administered to dairy cows via the intramammary route distribute into the aqueous and lipid fractions of the milk (Gruet, pg. 249, [4]). Therefore, intramammary injection necessarily results in administration to raw milk in the mammary gland. Regarding claims 54-56, the sequence alignments shown above demonstrate that the LytMCD, LssCWT, and linker sequence consist of SEQ ID NOs: 1, 2, and 3 respectively. As shown above, the combination of teachings from Jagielska and Erskine render claims 35, 37, 54-56, and 61 obvious at the time of filing. Accordingly, claims 35, 37, 54-56 and 61 are rejected.
(previous rejection, maintained) Claims 35, 37, 54-56 and 59-61 are rejected under 35 U.S.C. 103 as being unpatentable over Jagielska, Erskine, Gruet, and Uniprot as applied to claims 35, 37, 54-56 and 61 above, and further in view of Wang3 (see form PTO-892 Notice of References Cited).
As shown above, the combination of Jagielska, Erskine, and Gruet teach the limitations of claims 35, 37, 54-56 and 61.
Regarding claim 59, Jagielska, Erskine, and Gruet do not teach that the recombinant polypeptide of claim 35 comprises an attached CPP signal sequence at the N or C terminus of the LssCWT domain side.
Regarding claim 60, Jagielska, Erskine, and Gruet do not teach the signal sequence of SEQ ID NO: 9.
Wang teaches a CPP signal sequence referred to as CPPAnt (Wang, table 2). Wang teaches that the CPP signal sequence may be attached to N- or C-terminus of the JDlys sequence (Wang, pg. 10, [1]). The alignment between and instant SEQ ID NO: 9 is shown below:
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999
688
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As shown above, the amino acid sequence of CPPAnt taught by Wang is identical to the signal sequence of SEQ ID NO: 9.
At the time of filing, it would have been obvious to one of ordinary skill in the art to combine the teachings of Jagielska, Erskine, and Gruet, with the CPPAnt signal sequence taught by Wang. Particularly it would have been obvious to add the CPPAnt signal sequence to the N or C terminus of the LssCWT domain side of the recombinant fusion protein taught by Jagielska, to be used in the method taught by the combination of Jagielska, Erskine, and Gruet. One of ordinary skill would have been motivated to combine the above references because Wang teaches a fusion protein comprising the CPPAnt signal sequence and a cell wall hydrolase (JDlys) may be a worthwhile candidate as a treatment for skin and skin structure infections caused by MRSA (Wang, abstract). The recombinant fusion protein taught by Jagielska comprises a cell wall hydrolase domain (Jagielska, pg. 461, [3]). Furthermore, Gruet teaches that Mastitis caused by bacteria is difficult to treat because it is frequently resistant to antimicrobials, particularly β-lactams Additionally, one of ordinary skill in the art would have a reasonable expectation of success in combining the above teachings. Wang teaches that their findings suggest that the fusion protein CPP-JDlys is an antimicrobial agent active against skin infections caused by MRSA, and that CPP-JDlys could maintain high levels of activity and continuously inhibit the survival of MRSA strains in vivo. Additionally, Jagielska teaches that their recombinant fusion protein has activity against Staphylococcus strains, including MRSA (Jagielska, pg. 466, [2]). Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Jagielska, Erskine, Gruet, Uniprot, and Wang as described above. Accordingly, claims 35, 37, 54-56 and 59-61 are rejected.
Response to Arguments
Applicant's arguments filed 09*30/2025 have been fully considered but they are not persuasive.
Applicants argue that the Office did not treat the teachings of the cited publications in their entirety. Applicant argues that Erskine teaches that the success rate for chronic inflammatory infection caused by Staphylococcus aureus may be increased by using both parenteral and intramammary therapy and therefore Applicant argues that the active ingredient must be given both parenterally and intramammarily (see pg. 7). Applicant further argues that at the priority date there was no guidance toward a recombinant polypeptide of the instant claims that is active in raw milk and may be used for treatment by intramammary infusion and Applicant further argues that due to its activity in raw milk and the ability to penetrate into eukaryotic cells, the recombinant peptide of the instant claims may be used as the sole active ingredient administered intramammarily to treat mastitis (see pg. 8). Applicant argues that the unique activity of the recombinant polypeptide without a cell-penetrating peptide in raw milk is an unexpected feature (see pg. 8). Applicants further argue in the Affidavit (see pg. 2-4, 09/30/2025) and in Annex 1 (see pg. 1, 09/30/20) that high efficiency of peptidoglycan hydrolase in elimination of bacteria from milk is a unique and unexpected feature.
Applicant further argues that a person of ordinary skill would not have had a reasonable expectation of success in combining the teaching of Erskine and Jagielksa to arrive at the active ingredient in the form of a recombinant polypeptide of the invention for in vivo treatment or prevention of mastitis administered only intramammarily (see pg. 10).
With regards to the obviousness rejection based on Jagielska in view of Erskine, Gruet, and Wang, Applicant further argues that Wang does not teach or suggest the treatment of prevention of mastitis by administering a recombinant polypeptide to a subject as recited in claim 35 (see pg. 13).
The examiner does not find the arguments persuasive.
In response to the Applicant’s argument that one of ordinary skill would not have had a reasonable expectation of success combining the teaching of Erskine and Jagielksa to arrive at the active ingredient in the form of a recombinant polypeptide of the invention for in vivo treatment or prevention of mastitis administered only intramammarily, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Additionally, according the MPEP 2145 (IV), “One cannot show nonobviousness by attacking references individually where the rejections are based on a combination of references”.
Regarding claim 35, Jagielska teaches the recombinant peptide used in the method of claim 35 (see above rejection). Erskine teaches that intramammary infusion of commercial products that have good activity against gram-positive organisms should be administered to any cow with severe mastitis (see above rejection). Furthermore, Gruet teaches that pharmaceutical formulations administered to diary cows via the intramammary route distribute into the aqueous and lipid fraction of the milk (see above rejection). Therefore, the combined teachings of Jagielska, Erskine, and Gruet provide motivation to one of ordinary skill in the art to use the recombinant polypeptide of Jagielksa (which is the same as that used in the method of claim 35) for intramammary infusion and treatment of mastitis in cows (also see above rejection).
With regards to Applicant’s argument that at the priority date there was no guidance toward a recombinant polypeptide of the instant claims that is active in raw milk and that may be used for treatment by intramammary injection and that the unique activity of the recombinant polypeptide (with or without a cell-penetrating peptide) in raw milk is an unexpected feature (see pg. 8), the examiner does not find this argument persuasive.
Although Applicant states that the activity in raw milk of the recombinant polypeptide is not taught or suggested by the cited references (see pg. 8), the examiner notes that the recombinant polypeptide taught by Jagielska is substantially identical to the recombinant polypeptide used in the method of claim 35 which is shown in the sequence alignments in the rejection above (see above rejection). MPEP section 2112.01 states “where in the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products does not necessarily possess the characteristics of the claimed product.” Because the recombinant polypeptide taught by Jagielska is substantially identical to the recombinant polypeptide used in claim 35, the bacteriolytic activity in raw milk and/or serum appears to be an inherent characteristic that necessarily flows from the recombinant polypeptide taught by Jagielska.
In response to the Applicant’s argument that Wang does not teach or suggest the treatment or prevention of mastitis by administering a recombinant polypeptide to a subject as recited in claim 35 (see pg. 13), the examiner does not find the argument persuasive and notes that the combination of Jagielksa, Erskine, and Gruet teach the limitation of claims 35, 37, 54-56, and 61. Regarding claim 59, Jagielska, Erskine, and Gruet do not teach that the recombinant polypeptide of claim 35 comprises an attached CPP signal sequence at the N or C terminus of the LssCWT domain side (see above rejection). Regarding claim 60, Jagielska, Erskine, and Gruet do not teach the signal sequence of SEQ ID NO: 9, however, Wang teaches a CPP signal sequence referred to as CPPAnt (Wang, table 2). Wang teaches that the CPP signal sequence may be attached to N- or C-terminus of the JDlys sequence (Wang, pg. 10, [1]). The alignment between and instant SEQ ID NO: 9 is shown in the above rejection).
(new rejection, necessitated by amendments) Claims 35, 37, 54-56 and 59-64 are rejected under 35 U.S.C. 103 as being unpatentable over Jagielska, Erskine, Gruet, and Uniprot as applied to claims 35, 37, 54-56 and 61 above, and further in view of Wang (Appl. Environ. Microbiol., e00380-18, published May 31, 2018).
As shown above, the combination of Jagielska, Erskine, and Gruet teach the limitations of claims 35, 37, 54-56 and 61-64.
Regarding claims 59 and 62 and 64, Jagielska, Erskine, and Gruet do not teach that the recombinant polypeptide of claim 35 comprises an attached CPP signal sequence at the N or C terminus of the LssCWT domain side.
Regarding claim 60, 62, and 64, Jagielska, Erskine, and Gruet do not teach the signal sequence of SEQ ID NO: 9.
Wang teaches a CPP signal sequence referred to as CPPAnt (Wang, table 2). Wang teaches that the CPP signal sequence may be attached to N- or C-terminus of the JDlys sequence (Wang, pg. 10, [1]). The alignment between and instant SEQ ID NO: 9 is shown below:
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999
688
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As shown above, the amino acid sequence of CPPAnt taught by Wang is identical to the signal sequence of SEQ ID NO: 9.
At the time of filing, it would have been obvious to one of ordinary skill in the art to combine the teachings of Jagielska, Erskine, and Gruet, with the CPPAnt signal sequence taught by Wang. Particularly it would have been obvious to add the CPPAnt signal sequence to the N or C terminus of the LssCWT domain side of the recombinant fusion protein taught by Jagielska, to be used in the method taught by the combination of Jagielska, Erskine, and Gruet. One of ordinary skill would have been motivated to combine the above references because Wang teaches a fusion protein comprising the CPPAnt signal sequence and a cell wall hydrolase (JDlys) may be a worthwhile candidate as a treatment for skin and skin structure infections caused by MRSA (Wang, abstract). The recombinant fusion protein taught by Jagielska comprises a cell wall hydrolase domain (Jagielska, pg. 461, [3]). Furthermore, Gruet teaches that Mastitis caused by bacteria is difficult to treat because it is frequently resistant to antimicrobials, particularly β-lactams Additionally, one of ordinary skill in the art would have a reasonable expectation of success in combining the above teachings. Wang teaches that their findings suggest that the fusion protein CPP-JDlys is an antimicrobial agent active against skin infections caused by MRSA, and that CPP-JDlys could maintain high levels of activity and continuously inhibit the survival of MRSA strains in vivo. Additionally, Jagielska teaches that their recombinant fusion protein has activity against Staphylococcus strains, including MRSA (Jagielska, pg. 466, [2]).
With regards to claim 62 and 64, it would have been obvious to one of ordinary skill of the art before the effective filing date of the current invention to administer a mixture of the polypeptides as described in (a) and (b) since both recombinant polypeptides possess activity against Staphylococcus (see Jagielska, pg. 466 [2] and Wang, abstract). MPEP 2144.06 states "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).
Duplicate Claim Warning
(previous objection, withdrawn) Applicant is advised that should claim 57 be found allowable, claim 58 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 58 recites the recombinant polypeptide encoded by a polynucleotide comprising SEQ ID NO: 6, which necessarily requires the polypeptide to comprise SEQ ID NO: 5. As such, despite differences in wording, claims 57 and 58 cover the same scope.
Response to Arguments
Applicant’s arguments, see pg. 14, filed 09/30/2025 with respect to claim 58 have been fully considered and are persuasive. Applicant amended claim 58 to recite “comprises SEQ ID NO: 7”. The objection of 09/30/2025 has been withdrawn.
Conclusion
No claims allowed.
THIS ACTION IS MADE FINAL. 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 GEORGE T LOUNTOS whose telephone number is (571)272-0502. The examiner can normally be reached Monday-Friday 8:00 am - 5:00 pm.
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/GEORGE THEMISTOCLIS LOUNTOS/Examiner, Art Unit 1652
/ROBERT B MONDESI/Supervisory Patent Examiner, Art Unit 1652
1 Erskine, R. J. (2018). Mastitis in cattle - reproductive system. Merck Veterinary Manual. http://www.merckvetmanual.com/reproductive-system/mastitis-in-large-animals/mastitis-in-cattle
2 Gruet P. et al., Bovine mastitis and intramammary drug delivery: review and perspectives, Advanced Drug Delivery Reviews, 2001, Pages 245-259, https://doi.org/10.1016/S0169-409X(01)00160-0.
3 Wang Z, et al., Sun J.2018.A Phage Lysin Fused to a Cell-Penetrating Peptide Kills Intracellular Methicillin-Resistant Staphylococcus aureus in Keratinocytes and Has Potential as a Treatment for Skin Infections in Mice. Appl Environ Microbiol84:e00380-18.https://doi.org/10.1128/AEM.00380-18
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