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 .
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.
Priority
The instant application, filed 11/22/2022, claims priority to U.S. provisional application 63/283,068, filed 11/24/2021.
Status of Claims/Application
The amendment filed 08/07/2025 is acknowledged. Claims 1 and 13 are currently amended. Claim 2 has been cancelled. Claims 1 and 3-20 are currently pending and are examined on the merits herein.
Withdrawn Rejections and/or Objections
Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claim Rejections - 35 USC § 103
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.
Claims 1 and 3-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0041585 (Moeck et al) A1 published 02/18/2010 (cited in IDS filed 07/30/2023) in view of US 2016/0243190 A1 (Barriere et al) published 08/25/2016 (cited in PTO-892).
US’585 teaches that Bacillus anthracis is a Gram-positive spore-forming rod-shaped bacterium which is the causative agent of anthrax ([0001]). US’585 claims a method of treating B. anthracis infection in a subject, comprising administering a therapeutically effective amount of a glycopeptide antibiotic to a subject wherein the glycopeptide antibiotic is a compound as defined by Formula I, or a pharmaceutically acceptable salt thereof (claims 30 and 45); in particular, the glycopeptide antibiotic of Formula I includes telavancin ([0089]). US’585 also claims a method of preventing a B. anthracis infection in a subject at risk of exposure to B. anthracis, comprising administering to the subject an amount of a glycopeptide antibiotic of Formula I sufficient to prevent infection (claims 32 and 45). US’585 claims the glycopeptide antibiotic of both methods is in the form of a pharmaceutical composition comprising the glycopeptide antibiotic and a pharmaceutically acceptable carrier or diluent (claim 48). US’585 teaches said carriers include mannitol ([0222]), and said diluents include water for injection or 5% dextrose ([0233]). Mannitol, water for injection, and 5% dextrose read on the at least one pharmaceutical excipient as defined in the instant claims (see instant claim 3); therefore, US’585 reads on aspects of instant claims 1, 3, and 13.
Regarding the method of treating the B. anthracis infection, US’585 claims its method of treatment wherein the antibiotic is administered within 15 minutes of diagnosis of B. anthracis infection or exposure (claim 34); this reads on the limitations of instant claims 4 and 5 wherein the antibiotic is administered within 15 minutes or 48 hours, respectively, of exposure or diagnosis. US’585 claims this administration is intravenous (claim 42); this reads on instant claim 6. US’585 teaches that the therapeutically effective amount of the glycopeptide antibiotic of the invention is preferably between 3 to 15 mg/kg body weight, regardless of the formulation ([0240]). This range encompasses the claimed range for the therapeutically effective amount as recited in instant claim 7. US’585 also teaches that the administration frequency for the treatment of a subject having a B. anthracis infection includes once daily ([0242]); this reads on instant claim 8.
US’585 defines the term “subject” to refer to an animal such as a mammal, preferably a human ([0217]); therefore, the methods as recited above wherein a subject is treated read on the limitation of instant claim 9 wherein the subject is a mammal. US’585 claims its method of treatment wherein the B. anthracis is a vegetative form, a spore, or a mixture of both (claim 43); this reads on the limitation of instant claim 10. Furthermore, US’585 claims its method of treatment wherein the B. anthracis infection is selected from the group consisting of cutaneous anthrax, gastrointestinal anthrax, or inhalational anthrax (claim 44); this reads on the limitation of instant claim 11. US’585 teaches in each method that the glycopeptide antibiotic may be used alone ([0219]); this supports US’585’s singular claim language in claim 45 reciting the method of treatment wherein “the glycopeptide antibiotic is a compound as defined in Formula I, or a pharmaceutically acceptable salt” (emphasis added, note that “antibiotic” is in singular form). This reads on the limitation of instant claim 12, wherein the telavancin (which is defined to be the compound of Formula I in US’585) or pharmaceutically acceptable salt is the only antibiotic administered for treating the B. anthracis infection.
Regarding the method of preventing a B. anthracis infection, US’585 claims its method of prevention wherein the antibiotic is administered less than 24 hours or less than 15 days prior to the risk of exposure (claims 36 and 37). This reads on the administration time limitations of instant claims 14 and 15.
US’585 only differs from the instantly claimed invention in that it fails to teach its telavancin is telavancin hydrochloride when teaching its method for treating a B. anthracis infection in a subject (or mammal), as limited by instant claims 1 and 16-20. However, US’585 teaches that the “pharmaceutically acceptable salt” defined by its invention refers to non-toxic acid addition salts; acids commonly employed to form acid addition salts are inorganic acids such as hydrochloric acid ([0214]).
US’190 teaches that telavancin is a lipoglycopeptide antibacterial agent used to treat infections caused by susceptible Gram-positive bacteria in human patients, such as complicated skin and skin structure infections (cSSSI), hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP), and Staphylococcus aureus ([0005]). US’190 teaches a once-daily dose of telavancin for administration to a human patient having complications caused by the Gram-positive bacteria Staphylococcus aureus, wherein the telavancin is administered as a hydrochloride salt (claims 1 and 13). Furthermore, US’190 teaches the use of a storage-stable formulation of telavancin hydrochloride that is commercially available under the trademark VIBATIV® as a sterile, preservative-free powder containing telavancin hydrochloride, 2-hydroxypropyl-β-cyclodextrin, and mannitol ([0149]-[0150]). It is noted that VIBATIV® reads on the pharmaceutical composition limited in all of the instant claims, because, along with telavancin hydrochloride, it contains only 2-hydroxypropyl-β-cyclodextrin and mannitol, which are two of the defined pharmaceutical excipients limited by the instant claims 3 and 16.
It would have been prima facie obvious for a person having ordinary skill in the art, before the effective filing date of the claimed invention, to utilize a storage-stable, commercially available form of telavancin hydrochloride (in the pharmaceutical formulation VIBATIV®) as taught in US’190 in the method of treating B. anthracis infection in a human, as taught by US’585, and arrive at the instantly claimed invention. This would have been obvious because the use of telavancin hydrochloride (especially in the formulation VIBATIV®) was a known variation in art related to the use of antibiotics against Gram-positive bacterial infections, and the method of US’585 would have benefitted from the design incentives resulting from the use of the storage-stable, sterile, and preservative-free formulation provided by VIBATIV®. Furthermore, utilizing a pharmaceutical composition that is commercially available saves the time and resources that would otherwise be spent to formulate the composition used in the method of treating B. anthracis taught by US’585. In view of the teachings of US’190, the ordinarily skilled artisan would have implemented the use of VIBATIV® as the pharmaceutical composition in the method taught by US’585; there would have been predictable success because US’585 teaches that telavancin is the active antibiotic in the treatment of B. anthracis, and common acid addition salts applicable to its invention include those with hydrochloric acid, which is the telavancin salt present in VIBATIV®. Obviousness exists when known work in one field of endeavor will prompt variations of it for use in the same field based on design incentives or market forces if the variations are predictable to one of ordinary skill in the art (see MPEP 2143 I(F)).
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 1, 3-6 and 8-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4 and 5 of U.S. Patent No. 10,751,383 B2 in view of US 2010/0041585 A1 (Moeck et al) published 02/18/2010 (cited in IDS filed 07/30/2023) and US 2016/0243190 A1 (Barriere et al) published 08/25/2016 (cited in PTO-892 accompanying this action). It is noted that US’190 is an earlier-published PGPub from the prosecution process leading to the issuance of Patent US’383, and discloses the same subject matter as US’383.
US’383 claims a method of treating a patient having a creatinine clearance less than 30 mL/minute and having a complicated skin and skin structure infection caused by Staphylococcus aureus, comprising intravenously administering a once-daily dose of 3.8 mg/kg of telavancin (free base equivalent) or a pharmaceutically-acceptable salt thereof (claim 1). US’383 claims the telavancin is administered as a hydrochloride salt (claim 4), and the telavancin is administered in combination with 2-hydroxypropyl-β-cyclodextrin (claim 5). The instant application defines 2-hydroxypropyl-β-cyclodextrin to be a pharmaceutical excipient (see instant claim 3). Therefore, US’383 reads on certain limitations of at least claims 1, 3, 6, 8, 16 and 20.
US’383 differs from the instantly claimed invention in that it fails to claim its method for the treatment or prevention of B. anthracis infection in the patient, as recited in instant claims 1, 13, and 16. US’383 doesn’t claim its telavancin hydrochloride and 2-hydroxypropyl-β-cyclodextrin are administered together as a pharmaceutical composition, as limited by all instant claims. Furthermore, regarding its method of treatment of infection, US’383 doesn’t claim: the pharmaceutical composition is administered within 15 minutes or 48 hours of diagnosis, as recited in instant claims 4 and 5; the patient is a mammal, as recited in instant claim 9 and 16-20; the B. anthracis is in vegetative and/or spore form, as limited by instant claims 10 and 18; the B. anthracis infection is cutaneous anthrax, gastrointestinal anthrax, or inhalational anthrax, as limited by instant claims 11 and 17; the telavancin is the only antibiotic administered, as recited in instant claims 12 and 19. Regarding a method of preventing infection, US’383 furthermore doesn’t claim a pharmaceutical composition containing its telavancin hydrochloride and 2-hydroxypropyl-β-cyclodextrin are administered less than 24 hours or less than 15 days prior to risk of exposure, as recited in instant claims 14 and 15, respectively.
The teachings of US’585 and US’190 are addressed supra.
It would have been prima facie obvious before the effective filing date of the claimed invention to combine the teachings of US’383, US’585 and US’190 and perform the method of treating a patient claimed by US’383 by utilizing telavancin hydrochloride in combination with 2-hydroxypropyl-β-cyclodextrin in the form of a pharmaceutical composition as taught by US’190’s VIBATIV®, in order to treat and prevent Bacillus anthracis infection in a mammal using administration guidance taught by US’585. Regarding the use of the form of pharmaceutical composition (VIBATIV®), the use of the antibiotic telavancin in hydrochloride salt form and in combination with 2-hydroxypropyl-β-cyclodextrin within the pharmaceutical composition of VIBATIV® was a known variation in art related to the use of antibiotics against Gram-positive bacterial infections, and the method of US’383 would have benefitted from the design incentives resulting from the use of the storage-stable, sterile, and preservative-free formulation provided by VIBATIV®. In view of the teachings of US’190, the ordinarily skilled artisan would have implemented the use of the pharmaceutical composition VIBATIV® into the method taught by US’383, which requires the combination of telavancin hydrochloride and 2-hydroxypropyl-β-cyclodextrin. There would have been predictable success because US’190 teaches that telavancin is the active antibiotic in VIBATIV®, and is the same antibiotic used in US’383. Obviousness exists when known work in one field of endeavor will prompt variations of it for use in the same field based on design incentives or market forces if the variations are predictable to one of ordinary skill in the art (see MPEP 2143 I(F)).
Regarding using all of the teachings of US’585 to treat and prevent B. anthracis infection via the method of US’383, the ordinarily skilled artisan would have extended the use of telavancin disclosed in US’383 from treating S. aureus infection to instead treat and prevent B. anthracis infection, because the method is comparable to the method taught in US’585 which uses telavancin to treat and prevent B. anthracis. The ordinarily skilled artisan would have reasonably used all of the guidance taught by US’585 surrounding species of patient (human/mammal), administration times, B. anthracis form and infection type, and lack of other antibiotics used, because US’585 teaches the same antibiotic as the one used in the method of US’383 (telavancin) is effective at both treating and preventing B. anthracis infection following its taught administration guidelines. The use of these guidelines would have predictably resulted in success based on the fact that the dose of the method in US’383 (3.8 mg/kg) is well within the taught range of pharmaceutically acceptable dose for the prevention and treatment of B. anthracis infection as taught by US’585 (3-15 mg/kg). The ordinarily skilled artisan would have applied the method of US’383, with the administration guidance from US’585, to treat and prevent B. anthracis infection in a mammal patient because the use of telavancin according to US’585 was known for the treatment and prevention of B. anthracis infection in mammals (humans). Therefore, substituting the patient population of US’383 (those afflicted with S. aureus infection) with human patients needing treatment and/or prevention of B. anthracis infection would have predictably resulted in successful treatment and prevention of B. anthracis infection, when following the administration guidelines from US’585. Obviousness exists when simple substitution of one known element for another (in this case, the patient population and administration guidance) would obtain predictable results – see MPEP 2143 I(B).
Response to Arguments
Applicant’s arguments (filed on 08/07/2025) with respect to the 35 U.S.C. 102(a)(1) and 102(a)(2) rejection over claims 1 and 3-15 as being anticipated by Moeck (U.S. Pub No. 2010/0041585 A1), the 35 U.S.C. 103 rejection over claims 1-20 as being unpatentable over Moeck in view of Barriere (U.S. Pub No. 2016/0243190 A1), and the Non-Statutory Double Patenting rejection over claims 1-6 and 8-20 as unpatentable over claims 1, 4 and 5 of U.S. Patent No. 10,751,383 B2 in view of Moeck and Barriere made in the non-final action dated 05/07/2025 have been fully considered but are not found to be persuasive for the following reasons.
Regarding the 35 U.S.C. 102(a)(1) and 102(a)(2) rejection over claims 1 and 3-15 as being anticipated by Moeck (U.S. Pub No. 2010/0041585 A1), Applicant states that claims 1 and 13 have been amended to incorporate the language of claim 2, which was not rejected as being anticipated by Moeck.
Applicant' s arguments have been fully considered and, because of the amendments to claims 1 and 13, the 35 U.S.C. 102 anticipation rejection of claims 1 and 3-15 has been withdrawn.
Regarding the 35 U.S.C. 103 rejection over claims 1-20 as being unpatentable over Moeck in view of Barriere (U.S. Pub No. 2016/0243190 A1):
Applicant argues that, in order to reject a claim based on substitution of one known element for another, "Office personnel must articulate ... a finding that one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable." MPEP § 2143(I)(B) (emphasis added). Applicant alleges that such a finding has not been made, and cannot be made, in the present case. Applicant argues that no evidence or explanation was provided to support the conclusory statement that "substituting the patient population of US'383 (those afflicted with S. aureus infection) with human patients needing treatment and/or prevention of B. anthracis infection would have predictably resulted in successful treatment." (Office Action at 12). Applicant argues that one of ordinary skill in the art at the time of the invention would not reasonably expect that VIBATIV® could successfully treat a patient population with a different type of infection. Applicant cites Zhanel (IDS 07/30/2023) which states that glycopeptides such as telavancin have different activities (sometimes poor activity) against different pathogens. Moreover, Applicant argues that neither of the references cited by the Office provides evidence of VIBATIV'S® activity against B. anthracis infection. Accordingly, Applicant alleges that the Office has not met its burden to establish that the results of substituting patients with a different infection would have been predictable (Remarks pp. 5-6).
Applicant argues that the Office has not met its burden to articulate a finding that implementation of VIBATIV® would have been predictable. Applicant argues that because "Telavancin" is mentioned only one time in Moeck, and because it is one of a “multitude of compounds encompassed by Formula I,” this does not constitute evidence of its function in the treatment or prevention of B. anthracis infection. Applicant cites In re Wilson, which states that "[t]he burden is on the Examiner to first provide evidence establishing that compounds are well-known equivalents for a specific purpose." Applicant argues that there are no experimental examples or testing of telavancin disclosed by Moeck or any disclosure that would have provided one of skill with the belief that VIBATIV® could be successfully used to treat or prevent B. anthracis infection. Applicant argues Barriere fails to cure these deficiencies (Remarks p. 7).
These arguments are not found to be persuasive.
Regarding (a), firstly, nowhere in the non-final Action’s 35 U.S.C. 103 rejection over claims 1-20 is the Examiner invoking MPEP § 2143(I)(B) when providing a prima facie case for obviousness regarding instant claims 1-20 being unpatentable over Moeck in view of Barriere. Applicant appears to be mistakenly referencing the Examiner’s rationale specific to the NSDP rejection over claims 1-6 and 8-20 when alleging that the Office has invoked MPEP § 2143(I)(B) (see Remarks p. 6, wherein Applicant is discussing rationale from p. 12 of the Office Action dated 05/07/2025). Instead, the Examiner invoked MPEP § 2143(I)(F) by stating that obviousness exists when known work in one field of endeavor will prompt variations of it for use in the same field based on design incentives or market forces if the variations are predictable to one of ordinary skill in the art, and this is the basis of the Examiner’s statement that it would have been prima facie obvious for a person having ordinary skill in the art to utilize the storage-stable, commercially available form of telavancin hydrochloride (in the pharmaceutical formulation VIBATIV®) as taught in US’190 (Barriere) in the method of treating B. anthracis infection in a human, as taught by US’585 (Moeck) (see 05/07/2025 Office Action pp. 7-8 bridging para). It is assumed that the Applicant’s arguments regarding substitution of patient populations is intended to be in response to the NSDP rejection, and will be discussed in section 3 of this Response to Arguments below. Regarding the Applicant’s argument that neither of the references cited by the Office provides evidence of VIBATIV'S® activity against B. anthracis infection, despite there being a lack of specific evidence in the prior art that VIBATIV® (a commercially available form of telavancin hydrochloride) is active against B. anthracis infection, US’585 (Moeck) clearly teaches telavancin (or a pharmaceutically acceptable salt thereof) to be a particular embodiment of glycopeptide antibiotic used in a method of treating B. anthracis infection in a subject (claims 30 and 45; [0089]). Therefore, because telavancin is one of the particular glycopeptide antibiotics taught by Moeck to be used to treat B. anthracis infection in a subject, it would thus be prima facie obvious for a person having ordinary skill in the art to use telavancin hydrochloride (a pharmaceutically acceptable salt of telavancin) to treat B. anthracis infection. No evidence is necessary for it to be understood that B. anthracis is treated by telavancin, one of the particular embodiments of Formula I, in the method taught by Moeck.
Regarding (b), it is reiterated that, because telavancin is one of the particular embodiments of glycopeptide antibiotic of Formula I taught by Moeck to be used to treat B. anthracis infection in a subject, it would thus be prima facie obvious for a person having ordinary skill in the art to use VIBATIV® (telavancin hydrochloride, a pharmaceutically acceptable salt of telavanvin) to treat B. anthracis infection. Despite there being a lack of specific examples demonstrating the use of telavancin to treat or prevent B. anthracis infection, it would still be obvious to use VIBATIV® to treat B. anthracis infection purely because Moeck teaches telavancin to be a particular embodiment of the glycopeptide antibiotic used in a method of treating B. anthracis infection, and VIBATIV® is a stable form of telavancin desirably used to treat similar Gram-positive bacterial infections. It is also noted that Moeck provides only four particular embodiments for the glycopeptide antibiotic of formula I, these embodiments being oritavancin, teicoplanin, dalbavancin and telavancin ([0089]). This is hardly a “multitude of compounds encompassed by Formula I,” as alleged by the Applicant on p. 7 of the Remarks.
Regarding the Non-Statutory Double Patenting rejection over claims 1-6 and 8-20 as unpatentable over claims 1, 4 and 5 of U.S. Patent No. 10,751,383 B2 in view of Moeck and Barriere, Applicant argues that, for the same reasons the pending claims are non-obvious in view of Moeck and Barriere, as discussed above, the pending claims are not invalid for nonstatutory double patenting.
These arguments are not found to be persuasive. Regarding Applicant’s arguments mistakenly applied to the 35 U.S.C. 103 rejection above regarding an alleged lack of evidence or explanation to support the conclusory statement in Office Action p. 12 that "substituting the patient population of US'383 (those afflicted with S. aureus infection) with human patients needing treatment and/or prevention of B. anthracis infection would have predictably resulted in successful treatment," there is clear explanatory support in both the Examiner’s rationale and the combined teachings of the references for a person having ordinary skill in the art to reasonably expect telavancin hydrochloride (in the form of VIBATIV®) to treat B. anthracis infection. Please refer to the following quote from the Office action pp. 11-12:
“[T]he ordinarily skilled artisan would have extended the use of telavancin disclosed in US’383 from treating S. aureus infection to instead treat and prevent B. anthracis infection, because the method is comparable to the method taught in US’585 which uses telavancin to treat and prevent B. anthracis. The ordinarily skilled artisan would have reasonably used all of the guidance taught by US’585 surrounding species of patient (human/mammal), administration times, B. anthracis form and infection type, and lack of other antibiotics used, because US’585 teaches the same antibiotic as the one used in the method of US’383 (telavancin) is effective at both treating and preventing B. anthracis infection following its taught administration guidelines. The use of these guidelines would have predictably resulted in success based on the fact that the dose of the method in US’383 (3.8 mg/kg) is well within the taught range of pharmaceutically acceptable dose for the prevention and treatment of B. anthracis infection as taught by US’585 (3-15 mg/kg). The ordinarily skilled artisan would have applied the method of US’383, with the administration guidance from US’585, to treat and prevent B. anthracis infection in a mammal patient because the use of telavancin according to US’585 was known for the treatment and prevention of B. anthracis infection in mammals (humans).” (Emphasis added to highlight the explanations as to why the ordinarily skilled artisan would have a reasonable expectation of success using telavancin hydrochloride to treat B. anthracis in a population).
Please also see the rest of the response to the Applicant’s arguments supra regarding the teachings of US’383 (later publication of Barriere) and Moeck.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SOPHIA MARIE TAYLOR/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616