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 .
Priority
This application is a division of 16/306,262 filed on 11/30/2018 now U.S. Patent No. 11,872,216 which is a national stage entry of PCT/MA2017/000014 filed on 06/02/2017. Acknowledgment is made of applicant's claim for foreign priority based on applications filed in France and Morocco on June 02, 2016 under 35 U.S.C. 119 (a)-(d). The certified copies have been filed in parent Application No. 16/306,262, filed on November 30, 2018.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 14, 2025 has been entered.
Response to Amendment
No amendments to the claims were made by Applicant’s reply filed on August 14, 2025. Claims 1-11 are cancelled. Claims 12-22 are currently pending and presented for examination.
Response to Arguments
The terminal disclaimer filed on August 14, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,872,216 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Accordingly, the previous double patenting rejection over U.S. Patent No. 11,872,216 in view of Schateikis et al. is hereby withdrawn.
Applicant's arguments filed on August 14, 2025 with respect to the remaining rejections, have been fully considered but they are not persuasive.
With respect to the rejection under 35 U.S.C. § 103 over Tesse, Applicant argues that Tesse does not teach or suggest the claimed ratio of amoxicillin:cineole of about 5. Applicant argues that based on the teachings and examples of Tesse, an ordinary skilled artisan would not arrive at the claimed ratio of amoxicillin:cineole of about 5. Applicant further argues that paragraph [0083] which teaches a preferred ratio of from 1:1 to 1:5 is not directed to an amoxicillin:cineole ratio. Applicant further argues that in paragraph [0135], Tesse states: “In one alternative of the invention, the amoxicillin is dosed at 1000 mg/administration and cineole is dosed at 1 000 mg/administration, advantageously 500 mg/administration more preferentially to 250 mg/administration” which is equivalent to an amoxicillin:cineole ratio of 1:1, 2:1 or 4:1. Thus, Applicant argues that the claimed ratio cannot be considered obvious in light of Tesse, nor would the person skilled in the art be motivated to use such ratio.
These arguments are found not persuasive since it has been well established that consideration of a reference is not limited to the preferred embodiments or working examples, but extends to the entire disclosure for what it fairly teaches, when viewed in light of the admitted knowledge in the art, to a person of ordinary skill in the art. In re Boe, 355 F.2d 961,148 USPQ 507, 510 (CCPA 1966); In re Lambedi, 545 F.2d 747, 750, 192 USPQ 279,280 (CCPA 1976): In re FracalossL 681 F.2d 792,794, 215 USPQ 569, 570 (CCPA 1982)4 In re Kaslow, 707 F.2d 1366, 13:4,217 USPQ 1089, 1095 (Fed. Cir. 1983). Furthermore, disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or non-preferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ423 (CCPA 1971). Furthermore, “[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
In the instant case, Tesse teaches the combination of a compound of formula I which includes cineole and an antimicrobial agent which is preferably amoxicillin, wherein the mass ratio of the compound of formula I to the antimicrobial agent is in the range from 8:1 to 1:10 and most advantageously from 1:1 to 1:5 [0079]-[0083]. Thus Tesse teaches a mass ratio of an antimicrobial agent to a compound of formula I in the range of 1:8 to 10:1 and preferably 1:1 to 5:1. Thus Tesse specifically teaches that a preferable ratio of an antimicrobial agent to a compound of formula I is 5:1. Thus, despite Applicant’s arguments, an ordinary skilled artisan following the teachings of Tesse would only optimize the components of the composition within the ratio as specifically taught in Tesse and there is no reason or suggestion in Tesse to formulate a composition outside the range specifically taught in Tesse. Furthermore, claims 12, 17, 24 and 26 of Tesse specifically claim a ratio of a compound of formula (I) : antimicrobial agent ranging from 8:1 to 1:10; specifically from 1:1 to 1:5; wherein the compound of formula (I) is cineole and the antimicrobial agent is amoxicillin. Thus a skilled artisan would optimize the ratio of cineole:amoxicillin according to the direction provided in Tesse which would be a ratio of cineole to amoxicillin from 1:8 to 10:1, and specifically from 1:1 to 1:5.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.").
It is noted that Applicant has not provided any showing of unexpected results or criticality. In the instant specification starting on page 47 it is stated “Amoxicillin is a b-lactamase-sensitive antibiotic. b-Lactamases, which are produced by amoxicillin-resistant bacteria, recognize and inactivate the b-lactam core of amoxicillin. When it is placed in solution, preferably in an aqueous solvent, amoxicillin can transiently form complexes of two amoxicillin molecules. The formation of these complexes is too transient to have any protective effect against b-lactamases. However, when the pharmaceutical formulation of the invention is placed in solution, stable amoxicillin complexes comprising at least three amoxicillin molecules form and protect the antibiotic against the action of b- lactamases. The formation of these complexes may also be obtained by placing amoxicillin in solution in the presence of cineole. Thus, in a final aspect, the invention also relates to a molecular complex comprising more than two amoxicillin molecules organized linearly or in a ring and interacting with each other via non-covalent bonds. Preferably, the molecular complex of the invention is formed solely of amoxicillin molecules. The molecular complex of the invention is formed from at least three amoxicillin molecules, preferably from three to six amoxicillin molecules, more preferably from three or four amoxicillin molecules and most particularly preferably from four amoxicillin molecules. The amoxicillin molecules of the molecular complex of the invention may be organized linearly or in a ring. Preferably, they are organized in a ring so that each amoxicillin molecule interacts with two other amoxicillin molecules. In a particular embodiment, the amoxicillin molecules can pass freely from an organization as a linear complex to an organization as a ring complex by breaking or forming non-covalent bonds. The molecular complex of the invention may be obtained by placing amoxicillin in solution in the presence of cineole in an aqueous solvent. Preferably, the molecular complex of the invention is obtained by placing amoxicillin in solution in the presence of cineole in an aqueous solvent in the absence of detergent. In a particular embodiment, the molecular complex of the invention is obtained by placing the pharmaceutical formulation of the invention in solution in an aqueous solvent. Preferably, the amoxicillin molecules of the molecular complex of the invention are not recognized by b-lactamases. Thus, the molecular complex of the invention may be used in the treatment of bacteria considered as amoxicillin-resistant. In a particular embodiment, the molecular complex of the invention may be obtained in aqueous medium when the mass ratio of amoxicillin to cineole is between about 0.01 and about 1000, preferably between about 0.1 and about 100, more preferably between about 1 and about 10, and most particularly preferably when the mass ratio of amoxicillin to cineole is about 5.”
Thus based on the instant specification, the molecular complex is formed when amoxicillin is combined with water and cineole. There is no evidence in the instant specification which demonstrates criticality for the ratio of amoxicillin:cineole, nor has any declaration under 37 CFR 1.132 been presented which demonstrates such criticality. All Applicant presents is attorney argument, but “attorney argument [is] not the kind of factual evidence that is required to rebut a prima facie case of obviousness.” In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997).
Applicant further argues that the complexation of amoxicillin molecules in the presence of cineol prevents b-lactamases from attacking the b-lactam ring of amoxicillin, thereby preserving the antibacterial activity of amoxicillin in the presence of b-lactamases, enzymes frequently secreted by antibiotic-resistant bacteria. Applicant argues that Example 2 of the instant specification shows the protecting effect of cineol on amoxicillin in presence of beta-lactamase and Example 10 shows the specific organization of amoxicillin molecules in the form of trimers and tetramers when in presence of cineol. Applicant disagrees that the formation of trimers and tetramers would necessarily result from the teachings of Tesse and notes that Tesse dissolves the components of the disclosed compositions in a TWEEN 80/water solution and thus, it is not clear that such trimers and tetramers would arise from the teachings of Tesse and this surprising property/effect is neither taught nor suggested by Tesse.
These arguments are found not persuasive since Example 10 demonstrates that amoxicillin dissolved in water forms a complex comprising amoxicillin dimers, and when amoxicillin is dissolved in the presence of cineole, in addition to the peaks already observed for amoxicillin alone, new peaks appear corresponding to amoxicillin trimers and to amoxicillin tetramers. Example 10 further demonstrates that when amoxicillin is dissolved in the presence of clavulanic acid, and in the absence of cineole, the spectroscopic profile of amoxicillin is unchanged and thus, the addition of cineole allows the rearrangement of the amoxicillin molecules in solution in the form of oligomers of 3 to 4 amoxicillin molecules. Thus, this data demonstrates that cineole is necessary to form the claimed molecular complex. Although the mass ratio of amoxicillin to cineole in this example is 5:1 as claimed, no other amounts are shown which demonstrates criticality for the claimed ratio. For example, Applicant does not provide data for ratios above and below the claimed ratio which demonstrates that the molecular complex is not formed. Furthermore, other than detergent, the claims of the instant application do not exclude the presence of additional components. In addition, no evidence has been presented as argued by Applicant that demonstrates that the presence or absence of detergent or DMSO interferes with this molecular complex of amoxicillin. In addition, Example 2 merely demonstrates that cineole protects amoxicillin from b-lactamase. However, Tesse specifically teaches combining amoxicillin with cineole and thus this effect will necessarily occur in the prior art. Example 2 also does not demonstrate any criticality for the ratio as claimed and only demonstrates criticality for cineole. Since the prior art specifically teaches including cineole in the composition, this data is not sufficient to overcome the rejection of record.
Therefore, in the instant case, Tesse specifically teaches combining cineole with amoxicillin in water and thus, Tesse necessarily teaches the molecular complex as claimed in the instant claims. Tesse teaches the combination of a compound of formula I (cineole) and an antimicrobial agent (amoxicillin) wherein the mass ratio of the compound of formula I to the antimicrobial agent is in the range from 8:1 to 1:10 (amox:cineole 1:8 to 10:1) and most advantageously from 1:1 to 1:5 (amox:cineole 1:1 to 5:1) ([0079]-[0083] [0105] [0117] [0133] and claims 12, 17, 24 and 26). Tesse specifically teaches dilution of the compounds in a solvent wherein the solvent is Tween® 80 diluted with water, tween® 80 diluted with propylene, or DMSO diluted with water [0068]. Tesse specifically teaches the combination of cineole and amoxicillin as well as the combination of cineole and Augmentin (amoxicillin and clavulanic acid) in only water as the solvent [0169]-[0170]. Thus Tess teaches embodiments wherein detergent is excluded. Furthermore, it is noted that Tesse teaches that the pharmaceutical composition comprising the combination of a compound of formula I (cineole) and an antimicrobial agent (amoxicillin) can be in dry form, which dry form is to be reconstituted at the time of the use, in liquid form (in particular syrup, injectable, infusible or drinkable (elixir) solution or collyrium), or in an injectable form (in an aqueous, non-aqueous or isotonic solution) [0148]. Thus Tesse teaches that the combination of a compound of formula I (cineole) and an antimicrobial agent (amoxicillin) wherein the mass ratio of the compound of formula I to the antimicrobial agent is in the range from 8:1 to 1:10 (amox:cineole 1:8 to 10:1) and most advantageously from 1:1 to 1:5 (amox:cineole 1:1 to 5:1) can be in a suitable form for injection which is an aqueous solution. Thus it is maintained that Tesse teaches the molecular complex as claimed since Tesse teaches the combination of amoxicillin and cineole which is combined with water.
Thus, the claims of the instant application are rendered obvious in view of the teachings of Tesse which teaches combining amoxicillin and cineole in water in a preferred ratio of 5:1. Furthermore, with respect to Applicant’s argument that Tesse et al. does not teach the formation of trimers and tetramers in the presence of cineole or that this complex can overcome bacterial resistance to amoxicillin while reducing the rate of resistance prevalence, it is not necessary that the prior art suggests the same advantage or result discovered by applicant when the steps of the claim are the same as those described or suggested by the prior art. See, e.g., In re Kahn, 441 F.3d 977, 987 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Lintner, 458 F.2d 1013 (CCPA 1972); In re Dillon, 919 F.2d 688 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). The mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Prindle, 297 F.2d 251, 254 (CCPA 1962). Here, the latent property identified by Applicant is the formation of trimers and tetramers in the presence of cineole or that this complex can overcome bacterial resistance to amoxicillin while reducing the rate of resistance prevalence. Tesse specifically teaches combining cineole with amoxicillin to potentiate its activity and although Tesse does not teach how or why cineole potentiates amoxicillin, does not render nonobvious an otherwise known invention. Furthermore, because Tesse teaches the combination of amoxicillin and cineole which is combined with water, and moreover teaches combining the antibacterial agent (amoxicillin) and a compound of formula I (cineole) in a preferred ratio of 5:1, the properties discovered by Applicant will also be present in the prior art absent a demonstration to the contrary.
Therefore, in response to applicant's argument that Tesse et al. does not teach the formation of trimers and tetramers in the presence of cineole or that this complex can overcome bacterial resistance to amoxicillin while reducing the rate of resistance prevalence, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant further argues that Treacy et al. does not remedy the defects associated with the teachings of Tesse.
This argument is found not persuasive for the reasons as detailed above. In addition, although Tesse does not specifically teach treating the claimed bacterial infections, the teachings of Treacy et al. do make up for this deficiency since Treacy et al. teaches that amoxicillin may be used to treat pharyngitis, sinusitis, bronchitis, tonsillitis, pneumoniae, ear infection (otitis media), uncomplicated skin and skin structure infections, and uncomplicated urinary infections [0078].
Accordingly, prior to the effective filing date of the instant claims, it would have been obvious to a person of ordinary skill in the art to use the formulation of Tesse which contains amoxicillin, to treat common bacterial infections known in the art in which amoxicillin is useful, including sinusitis, bronchitis, otitis media and other bacterial infections.
Thus, for reasons of record, and for the reasons detailed above, the previous rejection under 35 USC 103 is hereby maintained and reproduced below. This action is FINAL.
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.
Claims 12-14 and 16-22 are rejected under 35 U.S.C. 103 as being unpatentable over Tesse WO 2016/041958 A1 (Provided on IDS) (equivalent document U.S. Publication No. 2018/0021296 A1 used as translation).
Claims 12-14 and 16-22 of the instant application claim a molecular complex comprising three to four amoxicillin molecules organized linearly or in a ring and interacting with each other by non-covalent bonds, and cineole, wherein the molecular complex is obtained by placing amoxicillin and cineole in an aqueous solvent and in the absence of detergent and wherein the mass ratio of amoxicillin to cineole is about 5, as well as a method of treating an infectious pathology such as a bacterial infection comprising administering said composition.
In the instant specification it is stated that “in the presence of cineole, amoxicillin forms a complex of at least three amoxicillin molecules.” See page 10 of the instant specification. It is further stated that “the present invention also relates to a molecular complex comprising more than two amoxicillin molecules organized linearly or in a ring and interacting with each other via noncovalent bonds. Preferably, the molecular complex according to the invention is formed from at least three amoxicillin molecules, more preferably from three to six amoxicillin molecules, and most particularly preferably from four amoxicillin molecules. The molecular complex according to the invention is obtained or may be obtained by dissolving amoxicillin in the presence of cineole in an aqueous solvent and in the absence of detergent.” See pages 5-6 of the instant specification.
Thus the claims are interpreted as a formulation comprising amoxicillin, cineole and an aqueous solvent such as water. Please note that “In determining whether the invention as a whole would have been obvious under 35 U.S.C. 103, we must first delineate the invention as a whole. In delineating the invention as a whole, we look not only to the subject matter which is literally recited in the claim in question... but also to those properties of the subject matter which are inherent in the subject matter and are disclosed in the specification. . . Just as we look to a chemical and its properties when we examine the obviousness of a composition of matter claim, it is this invention as a whole, and not some part of it, which must be obvious under 35 U.S.C. 103.” In re Antonie, 559 F.2d 618, 620, 195 USPQ 6,8 (CCPA 1977). See also Ex parte Novitski, 26 USPQ2d 1389 (Bd. Pat. App. & Inter. 1993) (The Board rejected a claim directed to a method for protecting a plant from plant pathogenic nematodes by inoculating the plant with a nematode inhibiting strain of P. cepacia. A U.S. patent to Dart disclosed inoculation using P. cepacia type Wisconsin 526 bacteria for protecting the plant from fungal disease. Dart was silent as to nematode inhibition but the Board concluded that nematode inhibition was an inherent property of the bacteria. The Board noted that applicant had stated in the specification that Wisconsin 526 possesses an 18% nematode inhibition rating.).
Tesse teaches the combination of a compound of formula I and an antimicrobial agent wherein the mass ratio of the compound of formula I to the antimicrobial agent is in the range from 8:1 to 1:10 and most advantageously from 1:1 to 1:5 [0079]-[0083]. Tesse teaches that the antimicrobial agent is preferably an antibiotic [0105]. Tesse further teaches preferably the compound of formula I is cineole [0117]. Tesse further teaches the antibiotic is preferably amoxicillin, amoxicillin/clavulanic acid, etc. [0133]. Tesse further teaches that in one embodiment the amoxicillin/clavulanic acid mixture: cineole ratio is 10:1, 1:1 or even 1:5 [0137]. Tesse specifically teaches the combination of cineole and amoxicillin as well as the combination of cineole and Augmentin (amoxicillin and clavulanic acid) (pages 9-14).
Tesse teaches the object of the invention is the compounds of formula (I), used at a dose at which they do not have antimicrobial properties any longer, for use as agents for potentiating the antimicrobial active ingredients with which they are co-administrated, wherein the “potentiator(s)+antimicrobial(s)” combination has the purpose of preventing and/or treating bacterial and fungal infections in humans or animals [0001]. Tesse specifically teaches the antimicrobial is amoxicillin for the treatment of the microbial infection which is a bacterial infection induced by a bacterial strain, of the cocci or positive-gram bacillus type, and [0134]. Tesse further teaches the treatment of a bacterium resistant to at least one, in particular at least two, in particular at least three, or even at least four, antibiotic(s) or antibiotic family(ies), conventionally used [0049]-[0051]. Tesse further teaches potentiation of an antimicrobial which means that the use of a compound according to the invention makes it possible to achieve a prophylactic or therapeutic effect higher than the prophylactic or therapeutic effect achieved using said antimicrobial(s) alone and this potentiation enables the resistance appearance to be reduced, or even cancelled [0064].
Tesse specifically exemplifies a composition comprising water, amoxicillin and cineole wherein the ratio of amoxicillin to cineole is 1:1.5 [0169]-[0170].
Thus Tesse specifically teaches a formulation comprising the combination of cineole and amoxicillin in water, and thus the formulation of Tesse will necessarily form a molecular complex comprising three to four amoxicillin molecules organized linearly or in a ring and interacting with each other by non-covalent bonds as claimed.
Tesse does not specifically exemplify a formulation having a mass ratio of amoxicillin to cineole of about 5 as claimed.
However, Tesse teaches the combination of a compound of formula I and an antimicrobial agent wherein the mass ratio of the compound of formula I to the antimicrobial agent is in the range from 8:1 to 1:10 and most advantageously from 1:1 to 1:5 [0079]-[0083]. Thus Tesse teaches a mass ratio of amoxicillin to cineole in the range of 1:8 to 10:1 and preferably 1:1 to 5:1.
Accordingly, it would have been obvious to a person of ordinary skill in the art to formulate the composition of Tesse having a mass ratio of amoxicillin to cineole at about 5 as claimed since Tesse specifically teaches preferred mass ratio ranges of amoxicillin to cineole in the range of 1:8 to 10:1 and preferably 1:1 to 5:1.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.").
Claims 21 and 22 are rendered obvious since Tesse specifically teaches that the cineole potentiates the antimicrobial agent which is preferably amoxicillin. Tesse further teaches the treatment of a bacterium resistant to at least one antibiotic. Tesse further teaches that this potentiation of an antimicrobial agent enables the resistance appearance to be reduced, or even cancelled [0064]. Accordingly, it would have been obvious to a person of ordinary skill in the art to use the combination of Tesse which combines amoxicillin and cineole for the treatment of amoxicillin resistant bacteria since Tesse teaches combining amoxicillin with cineole to potentiate its activity which enables resistance to be reduced or even cancelled. Furthermore, Tesse specifically teaches treating other bacteria resistant to other b-lactam antibiotics such as MRSA, in another alternative of the invention, the microbial infection is a bacterial infection induced by a methicillin-resistant E. coli or S. aureus type bacterial strain and the antimicrobial is an amoxicillin/clavulanic acid mixture [0136].
Furthermore, as detailed above, since Tesse renders obvious the same composition as claimed comprising the same components in the same amount, forming a molecular complex formed of four amoxicillin molecules, organized in a ring or organized linearly as claimed in claims 18-20 are rendered obvious.
"Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705,709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Thus the cited claims of the instant application are rendered obvious in view of the teachings of Tesse.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Tesse WO 2016/041958 A1 (Provided on IDS) (equivalent document U.S. Publication No. 2018/0021296 A1 used as translation) as applied to claims 12-14 and 16-22 above and further in view of Treacy et al. U.S. Publication No. 2008/0139526 A1.
Claim 15 of the instant application claims treating a bacterial infection selected from the group consisting of cystitis, recurring acute cystitis, bacterial sinusitis, acute maxillary sinusitis, otitis, acute otitis media, bronchitis, chronic and/or acute bronchitis, bronchopneumopathy, chronic and/or acute bronchopneumopathy, pyelonephritis, upper genital tract infections, parodontitis, severe stomatological infections, abscesses, phlegmons, cellulites, animal bites, bone and joint infections, and osteomyelitis.
Tesse is as set forth above.
Tesse does not specifically teach treating the claimed bacterial infections.
Treacy et al. teaches that amoxicillin may be used to treat pharyngitis, sinusitis, bronchitis, tonsillitis, pneumoniae, ear infection (otitis media), uncomplicated skin and skin structure infections, and uncomplicated urinary infections [0078].
Accordingly, prior to the effective filing date of the instant claims, it would have been obvious to a person of ordinary skill in the art to use the formulation of Tesse which contains amoxicillin, to treat common bacterial infections known in the art in which amoxicillin is useful, including sinusitis, bronchitis, otitis media and other bacterial infections.
Thus claim 15 is rendered obvious in view of the cited prior art teachings.
Conclusion
Claims 12-22 are rejected. Claims 1-11 are canceled. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA R. MCMILLIAN whose telephone number is (571)270-5236. The examiner can normally be reached Tuesday-Friday 12:00 PM-6:00 PM.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 KARA R. MCMILLIAN whose telephone number is (571)270-5236. The examiner can normally be reached Tuesday-Friday 12:00 PM-6:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached at (571)270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM