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 .
Terminal Disclaimer
The terminal disclaimer filed on 03/25/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of USPN 12,048,691 and copending application 18/665330 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 30-41 and 44-57 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jain et al. WO 2018112372 A1 (Jain ‘372).
Jain ‘372 teaches a tablet core comprising at least 65% tebipenem pivoxil HBr and tableting excipients. See abstract, and page 7. Tablet comprises 300 mg of tebipenem pivoxil in tablet weight of about 500 mg is found in page 12, paragraph 0054. The claimed diluent, binder, disintegrant and glidant in the claimed amount is found in pages 8-9 and Examples. The claimed method of treatment is found in pages 12-14 and claims. Microcrystalline, silicon dioxide and crospovidone having the claimed grade can be found in pages 8-9 and in the Examples.
Response to Arguments
Applicant's arguments filed 07/10/2026 have been fully considered but they are not persuasive.
Applicant argues that the § 102 rejection is legally deficient. The Office improperly combines multiple disclosures to allegedly anticipate the pending claims. For anticipation, the cited reference must teach every aspect of the claimed invention either explicitly or impliedly, and any feature not directly taught must be inherently present. Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628, 631 (Fed. Cir. 1987). Moreover, the single source must disclose all of the claimed elements "arranged or combined in the same way as in the claims." Net MoneyIN Inc. v. VeriSign,Inc., 545 F.3d 1359, 1369-70 (Fed. Cir. 2008); In re Arkley, 455 F.2d 586, 587-88 (CCPA 1972); Connell v. Sears Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983). "It is not-8-
enough that the prior art reference . . .includes multiple, distinct teachings that [an ordinary] artisan might somehow combine to achieve the claimed invention." Net MoneyIN Inc., 545 F.3d at 1369-70; In re Arkley, 455 F.2d 586, 587-88 (CCPA 1972) ("reference must clearly and unequivocally disclose the claimed compound or direct those skilled in the art to the compound without any need for picking, choosing, and combining various disclosures not directly related to each other by the teachings of the cited reference"). Additionally, the tebipenem pivoxil HBr tablet cores exemplified in Jain '372 contain a lower weight percentage tebipenem pivoxil HBr (46.5% or 58.2%) than the pending claims (70% to 80%) and either comprise mannitol (8.2% to 23.2%) or lactose (16.9%) as a diluent whereas the pending claims exclude these excipients. See, e.g., Jain '372 at Tables 11A, 11B, 12A, 12B, and 13. Thus, for at least these reasons, the claimed tebipenem pivoxil HBr tablet core is not anticipated by the tebipenem pivoxil HBr formulations of Jain '372. Accordingly, Applicant respectfully requests that the Office withdraw this rejection.
However, Applicant’s arguments are not persuasive for the following reasons:
In response to Applicant’s argument that the tebipenem pivoxil HBr tablet cores exemplified in Jain '372 contain a lower weight percentage tebipenem pivoxil HBr (46.5% or 58.2%) than the pending claims (70% to 80%) and either comprise mannitol (8.2% to 23.2%) or lactose (16.9%) as a diluent whereas the pending claims exclude these excipients. See, e.g., Jain '372 at Tables 11A, 11B, 12A, 12B, and 13, it is noted that disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994) (The invention was directed to an epoxy impregnated fiber-reinforced printed circuit material. The applied prior art reference taught a printed circuit material similar to that of the claims but impregnated with polyester-imide resin instead of epoxy. The reference, however, disclosed that epoxy was known for this use, but that epoxy impregnated circuit boards have "relatively acceptable dimensional stability" and "some degree of flexibility," but are inferior to circuit boards impregnated with polyester-imide resins. The court upheld the rejection concluding that applicant’s argument that the reference teaches away from using epoxy was insufficient to overcome the rejection since "Gurley asserted no discovery beyond what was known in the art." Id. at 554, 31 USPQ2d at 1132.). 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). The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). Here, Applicant’s attention is called to the teaching in paragraph 0038, where Jain ‘372 teaches the amount of tebipenem pivoxil in the tablet is 30% to 70% and the amount of pharmaceutically acceptablet excipients is 70% to 30%. First, Jain ‘372 teaches the amount of tebipenem pivoxil can be as much as 70%. Second, from this teaching, Jain ‘372 clearly read on the claim 70% tebipenem pivoxil.
Thus, for at least the above reasons, the 102(a)(1) rejection by Jain ‘372 is maintained.
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.
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 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.
Claims 30-57 are rejected under 35 U.S.C. 103 as being unpatentable over Jain et al. WO 2018145089 A1 (Jain ‘089), in view of Jain ‘372.
Jain ‘089 teaches new crystalline tebipenem pivoxil salt forms, including a crystalline tebipenem pivoxil hydrobromide salt form (Form B). The disclosure also includes a composition, comprising a crystalline tebipenem pivoxil salt and a pharmaceutically acceptable carrier and further includes a method for treating an antibiotic resistant bacterial infection, comprising administering to a patient in need of such treatment a therapeutically effective amount of a crystalline tebipenem pivoxil salt. The XRPD and HPLC analysis were repeated after one week of storage at 40°C, 75% relative humidity. The XRPD diffractogram showed characteristic peaks for tebipenem pivoxil maleate crystalline Form B. The tebipenem pivoxil maleate salt Form B, post storage, was 90.2 % pure by HPLC. See Abstract and paragraphs 0077-0081. Jain further teaches pharmaceutical compositions comprising at least one active agent, e.g., a crystalline tebipenem pivoxil salt, and at least one other substance, such as a carrier, excipient, or diluent. Pharmaceutical compositions meet the U.S. FDA's GMP (good manufacturing practice) standards for human or non-human drugs. See paragraph 0040. The disclosure includes a crystalline tebipenem pivoxil hydrobromide salt form (Form B), wherein the XPRD of the form, obtained from a Cu Ka source, has any 5, 6, 7, 8, 9, 10, 11, 12 or more of the following values: 9.3, 9.5, 10.7, 12.6, 13.0, 14.0, 15.2, 15.7, 17.6, 18.7, 19.1, 20.0, 20.4, 20.8,21.1, 21.9, 22.6, 23.5, 23.7, 24.9, 25.3, 25.5, 25.8, 26.1, 26.5, 26.8, 27.3, 27.6, 28.4, 28.8, 29.4, 29.7, or 29.9 +/- 0.2 degrees 2θ. Paragraph 0093. Tablet can be compressed tablets and can be prepared by compressing in a suitable machine the active ingredients in a free-flowing form such as powder or granules, optionally mixed with an excipient. Molded tablets can be made by molding in a suitable machine a mixture of the powdered compound moistened with an inert liquid diluent. Examples of excipients that can be used in oral dosage forms of the invention include, but are not limited to, binders, fillers, disintegrants, and lubricants. Binders suitable for use in pharmaceutical compositions and dosage forms include, but are not limited to, corn starch, potato starch, or other starches, gelatin, natural and synthetic gums such as acacia, sodium alginate, alginic acid, other alginates, powdered tragacanth, guar gum, cellulose and its derivatives (e.g. , ethyl cellulose, cellulose acetate, carboxymethyl cellulose calcium, sodium carboxymethyl cellulose), polyvinyl pyrrolidone, methyl cellulose, pre-gelatinized starch, hydroxypropyl methyl cellulose, (e.g. , Nos. 2208, 2906, 2910), microcrystalline cellulose, and mixtures thereof. Examples of fillers suitable for use in the pharmaceutical compositions and dosage forms disclosed herein include, but are not limited to, talc, calcium carbonate (e.g. , granules or powder), microcrystalline cellulose, powdered cellulose, dextrates, kaolin, mannitol, silicic acid, sorbitol, starch, pre-gelatinized starch, and mixtures thereof. The binder or filler in pharmaceutical compositions of the invention is typically present in from about 50 to about 99 weight percent of the pharmaceutical composition or dosage form. Suitable forms of microcrystalline cellulose include, but are not limited to, the materials sold as AVICEL-PH-101™, AVICEL-PH- 103™, AVICEL RC-581™, AVICEL- PH- 105™ (available from FMC Corporation, American Viscose Division, Avicel Sales, Marcus Hook, Pa.), and mixtures thereof. A specific binder is a mixture of microcrystalline cellulose and sodium carboxymethyl cellulose sold as AVICEL RC-581™. Suitable anhydrous or low moisture excipients or additives include AVICEL-PH- 103™ and Starch 1500 LM™. Disintegrants are used in the compositions of the invention to provide tablets that disintegrate when exposed to an aqueous environment. Tablets that contain too much disintegrant may disintegrate in storage, while those that contain too little may not disintegrate at a desired rate or under the desired conditions. Thus, a sufficient amount of disintegrant that is neither too much nor too little to detrimentally alter the release of the active ingredients should be used to form solid oral dosage forms of the invention. The amount of disintegrant used varies based upon the type of formulation, and is readily discernible to those of ordinary skill in the art. Typical pharmaceutical compositions comprise from about 0.5 to about 15 weight percent of disintegrant, specifically from about 1 to about 5 weight percent of disintegrant. Disintegrants that can be used in pharmaceutical compositions and dosage forms of the invention include, but are not limited to, agar-agar, alginic acid, calcium carbonate, microcrystalline cellulose, croscarmellose sodium, crospovidone, polacrilin potassium, sodium starch glycolate, potato or tapioca starch, pre-gelatinized starch, other starches, clays, other algins, other celluloses, gums, and mixtures thereof. Lubricants that can be used in pharmaceutical compositions and dosage forms of the invention include, but are not limited to, calcium stearate, magnesium stearate, mineral oil, light mineral oil, glycerin, sorbitol, mannitol, polyethylene glycol, other glycols, stearic acid, sodium lauryl sulfate, talc, hydrogenated vegetable oil (e.g. , peanut oil, cottonseed oil, sunflower oil, sesame oil, olive oil, corn oil, and soybean oil), zinc stearate, ethyl oleate, ethyl laureate, agar, and mixtures thereof. Additional lubricants include, for example, a syloid silica gel (AEROSIL 200™, manufactured by W.R. Grace Co. of Baltimore, Md.), a coagulated aerosol of synthetic silica (marketed by Degussa Co. of Piano, Tex.), CAB-O- SIL™ (a pyrogenic silicon dioxide product sold by Cabot Co. of Boston, Mass.), and mixtures thereof. If used at all, lubricants are typically used in an amount of less than about one weight percent of the pharmaceutical compositions or dosage forms into which they are incorporated. See paragraphs 0117-0122. Daily dosing is found in paragraph 0140. The pharmaceutical composition may be used to treat a disorder, e.g. , a bacterial infection. A method for treating a disorder may comprise administering to a patient in need of treatment a therapeutically effective amount of the pharmaceutical composition. See paragraph 0145.
Jain ‘089 does not expressly teach the components in a tablet core in the amounts recited in the claims.
Jain ‘372 teaches a tablet core comprising at least 65% tebipenem pivoxil HBr and tableting excipients. See abstract, and page 7. Tablet comprises 300 mg of tebipenem pivoxil in tablet weight of about 500 mg is found in page 12, paragraph 0054. The claimed diluent, binder, disintegrant and glidant in the claimed amount is found in pages 8-9 and Examples. The claimed method of treatment is found in pages 12-14 and claims. Microcrystalline, silicon dioxide and crospovidone having the claimed grade can be found in pages 8-9 and in the Examples.
Thus, it would have been prima facie obvious to one of ordinary skill in the art to, by routine experimentation select an amount that falls withing the claimed ranges in view of the teaching of Jain ‘372 with the expectation of at least similar result. This is because both of the Jain references teach the desirability to obtain a composition useful for the treatment of bacterial infection in a human, and this is because Jain ‘372 teaches a tablet core comprising the claimed components in the claimed amounts is known in the art.
Claims 30-57 are rejected under 35 U.S.C. 103 as being unpatentable over Bhiwgade et al. US 2008/0069879 A1, in view of Jain ‘089.
This rejection has been withdrawn in view of the Remarks filed on 07/10/2026. See pages 12-13.
Response to Arguments
Applicant's arguments filed 07/10/2026 have been fully considered but they are not persuasive.
Applicant argues that the Jain '372 does not provide any reason or motivation to specifically choose the claimed combinations. As discussed above, claim 30 is directed to a tablet core "consisting essentially of' very specific components at tightly defined weight percentage ranges. Specifically, claim 30 is-10-directed to tablet cores having 70% to 80% w/w tebipenem pivoxil HBr, 15% to 25% w/w of microcrystalline cellulose, 0.5% to 5% w/w of crospovidone, 0.5% to 2% w/w of silicon dioxide, and 0.5% to 2% w/w of magnesium stearate. Given the broad disclosure of Jain '372, a person of ordinary skill in the art would have only the examples to guide them. See Office Action at 9 (Office's reliance on Jain '372's examples as alleged support for its rejection). Here too, Jain '372 fails. The pending claims differ from Jain '372 by (1) containing a much higher weight percent of tebipenem pivoxil HBr (70% to 80%), whereas Jain '372 contains at most 58.2%.
However, Applicant’s attention is called to the teaching in paragraph 0038, which Jain ‘372 teaches the weight of tebipenem pivoxil at 70%. Therefore, one of ordinary skill in the art would have been motivated to, by routine experimentation select the amount of tebipenem pivoxil that falls within the claimed 70%-80% range given the teaching in Jain ‘372. It is noted that 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."). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%); In re Scherl, 156 F.2d 72, 74-75, 70 USPQ 204, 205-206 (CCPA 1946) (prior art showed an angle in a groove of up to 90° and an applicant claimed an angle of no less than 120°); In re Becket, 88 F.2d 684 (CCPA 1937) ("Where the component elements of alloys are the same, and where they approach so closely the same range of quantities as is here the case, it seems that there ought to be some noticeable difference in the qualities of the respective alloys."); In re Dreyfus, 73 F.2d 931, 934, 24 USPQ 52, 55 (CCPA 1934)(the prior art, which taught about 0.7:1 of alkali to water, renders unpatentable a claim that increased the proportion to at least 1:1 because there was no showing that the claimed proportions were critical); In re Lilienfeld, 67 F.2d 920, 924, 20 USPQ 53, 57 (CCPA 1933)(the prior art teaching an alkali cellulose containing minimal amounts of water, found by the Examiner to be in the 5-8% range, the claims sought to be patented were to an alkali cellulose with varying higher ranges of water (e.g., "not substantially less than 13%," "not substantially below 17%," and "between about 13[%] and 20%"); K-Swiss Inc. v. Glide N Lock GmbH, 567 Fed. App'x 906 (Fed. Cir. 2014)(reversing the Board's decision, in an appeal of an inter partes reexamination proceeding, that certain claims were not prima facie obvious due to non-overlapping ranges); In re Brandt, 886 F.3d 1171, 1177, 126 USPQ2d 1079, 1082 (Fed. Cir. 2018)(the court found a prima facie case of obviousness had been made in a predictable art wherein the claimed range of "less than 6 pounds per cubic feet" and the prior art range of "between 6 lbs./ft3 and 25 lbs./ft3" were so mathematically close that the difference between the claimed ranges was virtually negligible absent any showing of unexpected results or criticality.). "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005) (claimed alloy held obvious over prior art alloy that taught ranges of weight percentages overlapping, and in most instances completely encompassing, claimed ranges; furthermore, narrower ranges taught by reference overlapped all but one range in claimed invention). However, if the reference’s disclosed range is so broad as to encompass a very large number of possible distinct compositions, this might present a situation analogous to the obviousness of a species when the prior art broadly discloses a genus. Id. See also In re Baird, 16 F.3d 380, 383, 29 USPQ2d 1550, 1552 (Fed. Cir. 1994) ("[a] disclosure of millions of compounds does not render obvious a claim to three compounds, particularly when that disclosure indicates a preference leading away from the claimed compounds."); MPEP § 2144.08; and subsection III.D below for an additional discussion on consideration of prior art disclosures of a broad range.
A range can be disclosed in multiple prior art references instead of in a single prior art reference depending on the specific facts of the case. Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1322, 73 USPQ2d 1225, 1228 (Fed. Cir. 2004). The patent claim at issue was directed to a weight plate having 3 elongated openings that served as handles for transporting the weight plate. Multiple prior art patents each disclosed weight plates having 1, 2 or 4 elongated openings. 392 F.3d at 1319, 73 USPQ2d at 1226. The court stated that the claimed weight plate having 3 elongated openings fell within the "range" of the prior art and was thus presumed obvious. 392 F.3d at 1322, 73 USPQ2d at 1228. The court further stated that the "range" disclosed in multiple prior art patents is "a distinction without a difference" from previous range cases which involved a range disclosed in a single patent since the "prior art suggested that a larger number of elongated grips in the weight plates was beneficial… thus plainly suggesting that one skilled in the art look to the range appearing in the prior art." Id.
Thus, for at least the above reasons, the 103 rejection over the Jain references are maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615
