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 .
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 33-36) in the reply filed on 3/12/2025 is acknowledged.
Claims 37-52 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/12/2025.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement(s) (IDS) was/were submitted on 11/17/2023, 1/10/2024, 7/1/2024, and 4/3/2025 before the mailing of a first office action. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 33-53, submitted 9/18/2025 are currently pending. Claims 33-36 are currently under examination. Claims 37-52 are withdrawn. Claim 53 is new.
Response to Amendment
The affidavit under 37 CFR 1.132 filed 9/18/2025 is insufficient to overcome the rejection of claims 33-36 based upon 35 U.S.C. 103 as set forth in the last Office action because of the reasons described in detail in the following sections.
Response to Arguments
Applicant's arguments filed 9/18/2025 have been fully considered but they are not persuasive. Arguments shall be addressed in approximately the order in which they were present.
Claims 33 and 35-36 were previously rejected under 35 U.S.C. 103 as being unpatentable over Robertsen (Robertsen, et al. Antibiotics 8.4: 157 (2019)) in view of Noeske (Noeske, et al Antimicrobial agents and chemotherapy 58.9: 5269-5279 (2014)) as evidenced by Mast (Mast, et al. International Journal of Medical Microbiology 304.1:44-50 (2014)).
“Contrary to the Examiner's assertion, even if both references are considered together, a skilled practitioner still would not have been led to the combination of PIA and flopristin.” (Applicant Reply 9/18/2025, page 7) See also Applicant Declaration, 9/18/2025 section 5.
MPEP 2142 recites: “"To support the conclusion that the claimed invention is directed to obvious subject matter, either the references must expressly or impliedly suggest the claimed invention or the examiner must present a convincing line of reasoning as to why the artisan would have found the claimed invention to have been obvious in light of the teachings of the references." Ex parte Clapp, 227 USPQ 972, 973 (Bd. Pat. App. & Inter. 1985) (Emphasis added).
In the present case, the combination of pristinamycin IA (P1A) and flopristin is implied by the disclosures of Robertsen (Robertsen, et al. Antibiotics 8.4: 157 (2019) and Noeske (Noeske, et al Antimicrobial agents and chemotherapy 58.9: 5269-5279 (2014), not explicitly recited. Noeske in particular teaches the exact interactions of Streptogramin A molecules and Streptogramin B molecules with the bacterial ribosome (Noeske, page 5270, Figure 1). Noeske also teaches that “Streptogramins A and B must be used in combination, due to the fact that the individual streptogramin components exert a bacteriostatic effect, whereas their combination is bactericidal.” (Noeske, page 5269, col. 2, para. 3).
Robertsen provides a detailed explanation of the physiological effects of streptogramins: “The synergistic activity of the type A and B streptogramins can be explained from the unique MOA, in that both antibiotics bind to the prokaryotic 50S ribosomal subunit however, at separate sites. The type A substances inhibit the early phase of protein elongation through their binding to the A and P sites on the 23S rRNA, thereby preventing the attachment of tRNA at each site [149,278]. Type B streptogramins also bind to the P site on the ribosome however, inhibit the late stage of polypeptide chain elongation by binding the exit tunnel of the ribosome. As a result, elongation of the nascent polypeptide chain is prevented and incomplete peptide chains are released from the complex.” (Robertsen, page 25, para. 3).
MPEP 2141.03(I) states: “"A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397”. A person of ordinary skill in the art would reasonably expect members of the Streptogramin A family and Streptogramin B family to behave in accordance with Figure 1 of Noeske. Consequently, a person of ordinary skill in the art would reasonably expect any combination of Streptogramin A and Streptogramin B molecules to possess the synergistic effect disclosed by Noeske. A person of ordinary skill in the art would reasonably expect the pristinamycin 1A of Robertsen to have the same physiological effect as the Streptogramin B molecules disclosed by Noeske.
Therefore, a person of ordinary skill in the art would be led to this combination because as MPEP 2144.06(I) 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).” This is especially relevant in a case such as this where the prior art predicts a synergistic effect.
“It was well-known that PIA and PIIA are naturally synergistic resulting from being co-produced by the same bacteria and co- evolved for optimal synergy. On the other hand, NXL-103 and Synercid® are both composed solely of semi-synthetic compounds. There is nothing in any of the references to suggest mixing a natural streptogramin component and a synthetic streptogramin compound. Indeed, a skilled practitioner would have been discouraged from combining a natural streptogramin compound with a semi-synthetic streptogramin compound, a combination that can potentially disrupt synergy.” (Applicant Reply, 9/18/2025, pages 7-8). See also Applicant Declaration, 9/18/2025, section 5.
Nothing in the provided references makes any distinction between the mechanism of natural molecules and semi-synthetic molecules. Both Noeske and Robertsen refer to the streptogramin A and streptogramin B molecules in a general manner. No indication is provided that mechanistic differences exist based on the origin of said molecule. Properties of molecules are based on their structure as described in MPEP 2112.01(II): “A chemical composition and its properties are inseparable.” While the molecules in question are not identical, the prior art shows no indication that the mechanistic scheme disclosed by Noeske Figure 1 changes because of the origin of synthesis.
“Even assuming that a skilled practitioner would have been led to try to combine PIA and flopristin, there would have been no reasonable expectation of success. The Declaration sets forth data demonstrating that the outcome of any streptogramin A component and streptogramin B combination is highly unpredictable. See paragraphs 6-9. Notably, pairing the streptogramin B
component of pristinamycin (i.e., PIA) with the streptogramin A of NXL-103 (i.e., flopristin) results in very potent antibacterial activities, but combining the streptogramin B component of NXL-103 (i.e., linopristin) with the streptogramin A component of pristinamycin (i.e., PIIA) leads to very poor activities.” (Applicant Reply 9/18/2025, page 8). See also Applicant Declaration, 9/18/2025, sections 6-9.
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., a specific MIC value) are not recited in the rejected claim. 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). The current claims are not drawn to a combination of a specific activity level, only the combination itself.
Furthermore, the Declaration filed 9/18/2025 uses CBA1 vs CBA6 as an example of unpredictability of streptogramin combination (Applicant Declaration 9/18/2025, page 4, Table B). While it is true that CBA1 is more effective than CBA6, this is not the correct comparison in this case. A better comparison is CBA6, linopristin/pristinamycin IIA, compared to linopristin alone, as disclosed by Noeske in Table 1 (Noeske, page 5274, Table 1). Here, linopristin alone against H. influenzae has an MIC of >64, whereas Applicant Declaration reports CBA6 as having an MIC of 1.5 against H. influenzae. This is the exact synergy as predicted by Noeske as described above. The characterization of the activity of CBA6 as “poor” only applies in comparison to other synergistic combinations, not in comparison to single molecule treatments. Consequently, this comparison does not alter the reasonable expectation of success of a skilled artisan combining a streptogramin A molecule and a streptogramin B molecule in the general case.
“Even if one further assumes that the Examiner has established a prima facie case of obviousness respecting claim 33 over Robertsen in view of Noeske, the Declaration provides ample evidence of non-obviousness sufficient to rebut it.
Paragraphs 10-16 and Tables C-K in the Declaration show that the combination of PIA and flopristin consistently demonstrates surprisingly superior antimicrobial activities across four bacterial species and twelve strains over a wide range of component ratios as compared to eight other streptogramin B/streptogramin A combinations, including pristinamycin (PIA-PIIA), NXL- 103 (L-F), and Synercid® (Q-D).” (Applicant Reply 9/18/2025, page 8). See also Applicant Declaration, 9/18/2025, sections 10-16.
MPEP 716.02(c)(I) states: “"Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof." In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967).” Specifically, it is of critical importance that the synergistic effects of streptogramin A and streptogramin B molecules were known before the effective filing date of the claimed invention. Consequently, the given synergistic effect between a Streptogramin A and Streptogramin B would not be an unexpected result. Noeske discloses a table which shows an analysis of this synergistic effect for select molecules. (Noeske, page 5274, Table 1).
According to Noeske, Synercid® and NXL103 both have synergistic effects compared to their individual components. However, compared to each other, significant differences exist. NXL-103 is 4X more potent against E. coli, 16X more potent against H. influenzae, 4X more potent against E. faecalis, and so forth (Noeske, page 5274, Table 1). A person of ordinary skill in the art would recognize that such differences would potentially exist between any two combinations of streptogramin A and streptogramin B molecules.
Applicant specification Table 3 shows that CBA1 has a mean MIC of 0.19, which is less than 2X potent than the known linopristin-flopristin combination. CBA1 is 4X more potent than CBA6, but again, this is well within the difference in potency disclosed by Noeske between Synercid® and NXL103. So in this context, a difference of 4X potency was entirely expected as a possible outcome of the experiment. A person of ordinary skill in the art would be aware of the potential differences in efficacy between streptogramin A and streptogramin B combinations and use this knowledge to engage in an optimization procedure.
V. “In addition, as averred in paragraphs 17 and 18 in the Declaration, pairing PIA with flopristin offers a new and improved solution to a long-felt but unmet need due to the lack of streptogramin antibiotics.” (Applicant Reply 9/18/2025, page 9). See also Applicant Declaration, 9/18/2025, sections 17-18.
As noted by Applicant Declaration, Synercid® and NXL103 already exist and are theoretically available if regulatory agencies and pharmaceutical industries were to pursue those compositions (Applicant Declaration, 9/18/2025, page 10). A solution not being approved or successful is not the same as not existing. Furthermore, without regulatory approval in the United States, this disclosed composition has the same regulatory status as pristinamycin and therefore is not an improvement in fulfilling any unmet need.
Additionally, MPEP 716.04(I) states: “ First, the need must have been a persistent one that was recognized by those of ordinary skill in the art. In re Gershon, 372 F.2d 535, 539, 152 USPQ 602, 605 (CCPA 1967).” The referenced commercial failure in Applicant Declaration arguably speaks against the existence of a persistent need. While additional antibiotics are recognized by those of ordinary skill in the art, the persistent need for this particular class of antibiotics has not been established.
For the above reasons, the rejection of claim 33 over Robertsen in view of Noeske as evidenced by Mast is maintained.
Regarding claims 35 and 36, the above analysis does not change the nature of the rejection of claims 35 and 36.
Regarding claim 35, claim 35 recites: “A kit or a packaged article, comprising a first composition comprising pristinamycin IA or a pharmaceutically acceptable salt thereof; and a second composition comprising flopristin or a pharmaceutically acceptable salt thereof; and instructions for administering the first composition and the second composition in a method for treating an infection caused at least in part by a bacterium in a subject.”
This claim is very similar to claim 33, except for the addition of instructions for use.
MPEP 2111.05(I)(B) states: “Where a product merely serves as a support for printed matter, no functional relationship exists.” The MPEP also states: “For example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals. In re Ngai, 367 F.3d at 1339, 70 USPQ2d at 1864.”
Furthermore, MPEP 2111.05 states: “"[O]nce it is determined that the limitation is directed to printed matter, [the examiner] must then determine if the matter is functionally or structurally related to the associated physical substrate, and only if the answer is ‘no’ is the printed matter owed no patentable weight." In re DiStefano, 808 F.3d at 850, 117 USPQ2d at 1268.
Consequently, in this situation, the printed matter is owed no patentable weight and the rejection is maintained.
Regarding claim 36, claim 35 is obvious as described above. Claim 36 recites: “The kit or packaged article of claim 35 wherein the instructions include administering to the subject the first composition and the second composition simultaneously, administering the first composition before the second composition is administered, or administering the first composition after the second composition is administered.”
MPEP 2111.05(I)(B) states: “Where a product merely serves as a support for printed matter, no functional relationship exists.” The MPEP also states: “For example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals. In re Ngai, 367 F.3d at 1339, 70 USPQ2d at 1864.”
Furthermore, MPEP 2111.05 states: “"[O]nce it is determined that the limitation is directed to printed matter, [the examiner] must then determine if the matter is functionally or structurally related to the associated physical substrate, and only if the answer is ‘no’ is the printed matter owed no patentable weight." In re DiStefano, 808 F.3d at 850, 117 USPQ2d at 1268.
Consequently, in this situation, the printed matter is owed no patentable weight and the rejection is maintained.
Claim 34 was previously rejected under 35 U.S.C. 103 as being unpatentable over Robertsen (Robertsen, et al. Antibiotics 8.4: 157 (2019)) in view of Noeske (Noeske, et al Antimicrobial agents and chemotherapy 58.9: 5269-5279 (2014)) as evidenced by Mast (Mast, et al. International Journal of Medical Microbiology 304.1:44-50 (2014)) as applied to claim 33 above, and further evidenced by Politano (.Politano, et al. Current opinion in investigational drugs (London, England: 2000) 11.2: 225 (2010)) and Abdel-Hamid ( Abdel-Hamid et al, Journal of pharmaceutical and biomedical analysis 32.6: 1167-1174 (2003)).
Regarding claim 34, the rejection of claim 33 is maintained as described above. The above analysis does not change the nature of this rejection for claim 34. Claim 34 recites the limitation: “The composition of claim 33 wherein the PIA:flopristin ratio is in the range from about 1:99 to about 99:1 by weight.”
Robertsen discloses that the two substances pristinamycin IIA and pristinamycin IA are produced and used in a 70:30 ratio (Robertsen, page 24, para. 1). Additionally, Politano discloses that “NXL103 is a 70/30 mixture of streptogramin A/streptogramin B components” (Politano, Abstract), and Abdel-Hamid discloses that “Synercid is a combination of two semisynthetic pristinamycin derivatives, quinupristin and dalfopristin in 30:70 (w/w) ratio.” (Abdel-Hamid, Abstract).
This ratio lies within the range provided for claim 34. MPEP 2131.03 (I) states: “"If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). Due to the nature of claim 33, anticipation is not appropriate, but instead supports a finding of obviousness.
Therefore, claim 34 is obvious over Robertsen in view of Noeske, as evidenced by Mast, Politano, and Abdel-Hamid and the rejection is maintained.
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.
Maintained rejections
Claims 33 and 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Robertsen (Robertsen, et al. Antibiotics 8.4: 157 (2019)) in view of Noeske (Noeske, et al Antimicrobial agents and chemotherapy 58.9: 5269-5279 (2014)) as evidenced by Mast (Mast, et al. International Journal of Medical Microbiology 304.1:44-50 (2014)).
Regarding claim 33, claim 33 recites “A composition comprising pristinamycin IA (PIA) or a pharmaceutically acceptable salt thereof; and flopristin or a pharmaceutically acceptable salt thereof.”
Robertsen discloses that the antibiotic pristinamycin is composed of two substances: pristinamycin IIA and pristinamycin IA (Robertsen, page 24, para. 1 and Fig. 8). Mast further discloses that pristinamycin II congeners are of the streptogramin A type and pristinamycin I congeners are of the streptogramin B type (Mast 2014, page 45, Fig. 1).
Robertsen does not disclose the case where streptogramin A component is flopristin and the streoptogramin B component is pristinamycin IA. However, Noeske discloses two products, Synercid and NXL 103, wherein streptogramin type A molecules (dalfopristin and flopristin) are combined with streptogramin type B molecules (quinupristin and linopristin) to result in functional antibiotics (Noeske, page 5269, col. 2, para 2). Mast discloses that “In the beginning, pristinamycin was only introduced as a drug in France, Belgium, the Netherlands, and Germany.”, so the combination of pristinamycin IIA and pristinamycin IA has been used as a drug as well (Mast 2014, page 45, col. 1, para. 3)
Noeske further discloses that: “Streptogramins A and B must be used in combination, due to the fact that the individual streptogramin components exert a bacteriostatic effect, whereas their combination is bactericidal.” (Noeske, page 5269, col. 2, para 2). Noeske shows how streptogramins A and B interact with A2062 of the 70S bacterial ribosome, but do not appear to interact with each other in any meaningful way (Noeske, page 5260, Fig. 1).
It would have been obvious to a person of ordinary skill in the art before the effective file date of the claimed invention to combine pristinamycin IA as disclosed by Robertsen with flopristin as disclosed by Noeske to arrive at the invention recited in claim 33. A person of ordinary skill in the art would have a reasonable expectation of success in combining these two molecules for at least two reasons. First, both molecules have been used in known antibiotics already. Second, each molecule must have exhibited the necessary streptogramin A and B activity in those antibiotics. MPEP 2144.06(I) 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).”
Specifically, the binding affinity of streptogramin B molecules is known to increase in the presence of streptogramin A molecules. (Noeske, page 5271, col. 1, para. 1). Based on the activity of NXL 103 using flopristin and the activity of pristinamycin using pristinamycin IA, each molecule had sufficient individual efficacy to make those antibiotics active; therefore, a person of ordinary skill in the art would expect flopristin to bind to the bacterial ribosome and increase in the affinity pristinamycin IA for said ribosome in a similar manner as other streptogramin antibiotics, resulting in an active antibiotic.
Consequently, claim 33 is obvious over Robertsen in view of Noeske as evidenced by Mast and rejected.
Regarding claim 35, claim 35 recites: “A kit or a packaged article, comprising a first composition comprising pristinamycin IA or a pharmaceutically acceptable salt thereof; and a second composition comprising flopristin or a pharmaceutically acceptable salt thereof; and instructions for administering the first composition and the second composition in a method for treating an infection caused at least in part by a bacterium in a subject.”
This claim is very similar to claim 33, except for the addition of instructions for use.
MPEP 2111.05(I)(B) states: “Where a product merely serves as a support for printed matter, no functional relationship exists.” The MPEP also states: “For example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals. In re Ngai, 367 F.3d at 1339, 70 USPQ2d at 1864.”
Furthermore, MPEP 2111.05 states: “"[O]nce it is determined that the limitation is directed to printed matter, [the examiner] must then determine if the matter is functionally or structurally related to the associated physical substrate, and only if the answer is ‘no’ is the printed matter owed no patentable weight." In re DiStefano, 808 F.3d at 850, 117 USPQ2d at 1268.
Consequently, in this situation, the printed matter is owed no patentable weight and claim 35 is rejected on the same grounds as claim 33 above.
Regarding claim 36, claim 35 is obvious as described above. Claim 36 recites: “The kit or packaged article of claim 35 wherein the instructions include administering to the subject the first composition and the second composition simultaneously, administering the first composition before the second composition is administered, or administering the first composition after the second composition is administered.”
MPEP 2111.05(I)(B) states: “Where a product merely serves as a support for printed matter, no functional relationship exists.” The MPEP also states: “For example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals. In re Ngai, 367 F.3d at 1339, 70 USPQ2d at 1864.”
Furthermore, MPEP 2111.05 states: “"[O]nce it is determined that the limitation is directed to printed matter, [the examiner] must then determine if the matter is functionally or structurally related to the associated physical substrate, and only if the answer is ‘no’ is the printed matter owed no patentable weight." In re DiStefano, 808 F.3d at 850, 117 USPQ2d at 1268.
Consequently, in this situation, the printed matter is owed no patentable weight and claim 36 is rejected on the same grounds as claim 33 above.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Robertsen (Robertsen, et al. Antibiotics 8.4: 157 (2019)) in view of Noeske (Noeske, et al Antimicrobial agents and chemotherapy 58.9: 5269-5279 (2014)) as evidenced by Mast (Mast, et al. International Journal of Medical Microbiology 304.1:44-50 (2014)) as applied to claim 33 above, and further evidenced by Politano (.Politano, et al. Current opinion in investigational drugs (London, England: 2000) 11.2: 225 (2010)) and Abdel-Hamid ( Abdel-Hamid et al, Journal of pharmaceutical and biomedical analysis 32.6: 1167-1174 (2003)).
Regarding claim 34, claim 33 is rejected as described above. Claim 34 recites the limitation: “The composition of claim 33 wherein the PIA:flopristin ratio is in the range from about 1:99 to about 99:1 by weight.”
Robertsen discloses that the two substances pristinamycin IIA and pristinamycin IA are produced and used in a 70:30 ratio (Robertsen, page 24, para. 1). Additionally, Politano discloses that “NXL103 is a 70/30 mixture of streptogramin A/streptogramin B components” (Politano, Abstract), and Abdel-Hamid discloses that “Synercid is a combination of two semisynthetic pristinamycin derivatives, quinupristin and dalfopristin in 30:70 (w/w) ratio.” (Abdel-Hamid, Abstract).
Consequently, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to try a formulation of 70/30 flopristin to pristinamycin IA. A person of ordinary skill in the art would be motivated to try this ratio because the above described streptogramin antibiotics use this ratio.
This ratio lies within the range provided for claim 34. MPEP 2131.03 (I) states: “"If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). Due to the nature of claim 33, anticipation is not appropriate, but instead supports a finding of obviousness.
Therefore, claim 34 is obvious over Robertsen in view of Noeske, as evidenced by Mast, Politano, and Abdel-Hamid and rejected.
New rejection
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Robertsen (Robertsen, et al. Antibiotics 8.4: 157 (2019)) in view of Noeske (Noeske, et al Antimicrobial agents and chemotherapy 58.9: 5269-5279 (2014)) as evidenced by Mast (Mast, et al. International Journal of Medical Microbiology 304.1:44-50 (2014)) as applied to claim 33 above, further in view of Chaudhari et al. (Chaudhari, et al. Int J Adv Pharm Biol Chem 1.1: 21-34 (2012)).
Regarding claim 53, claim 33 is obvious as described above. Claim 53 further recites a carrier, vehicle, excipient or diluent. Chaudhari discloses a variety of excipients and motivation of a person of ordinary skill in the art to include them depending on the specific need (Chaudhari, page 28, Table 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the composition of claim 33 with the excipients disclosed by Chaudhari to arrive at the claimed invention. A person of ordinary skill in the art would have a reasonable expectation of success: “Excipients can be considered as indispensable component of medicinal products and in most of the formulations they are present in greater proportion with regards to active pharmaceutical ingredient, as it forms the bulk of the formulation it is always necessary to select an excipient which satisfies the ideal properties for a particular excipient.” (Chaudhari, page 22, col. 1, para. 2).
Consequently, claim 53 is obvious over Robertsen in view of Noeske as evidenced by Mast as applied to claim 33 above, and further in view of Chaudhari and rejected.
Rejoinder
Applicant has requested rejoinder of claims 37-50 pursuant to MPEP 821.04(b). MPEP 821.04 states: “In order to be eligible for rejoinder, a claim to a nonelected invention must depend from or otherwise require all the limitations of an allowable claim. A withdrawn claim that does not require all the limitations of an allowable claim will not be rejoined.”
No claims are currently allowed; therefore these claims will not be rejoined at this time.
Conclusion
No claim is allowed.
Rejections are maintained for claims 33-36.
Claim 53 is rejected.
Claims 37-50 are not rejoined at this time.
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 David Paul Bowles whose telephone number is (571)272-0919. The examiner can normally be reached Monday-Friday 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID PAUL BOWLES/ Examiner, Art Unit 1654
/LIANKO G GARYU/ Supervisory Patent Examiner, Art Unit 1654