DETAILED ACTION
RESPONSE TO AMENDMENT
1. Receipt of Applicants’ amendments and arguments/remarks filed 12/19/2025 is acknowledged.
INFORMATION DISCLOSURE STATEMENT
2. No new Information Statement has been submitted for review.
WITHDRAWN REJECTIONS
3. Rejections not reiterated from previous Office Actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
NEW REJECTIONS
4. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5-12, 19 and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Loira Pastoriza et al. (WO 2019038430) in view of Hao et al. (US 20070254035 and Parcq et al. (US 20230233686).
Loira Pastoriza et al. (WO 2019038430) (hereinafter Loira Pastoriza et al.) disclose an extrudate of at least one protoberberine alkaloid and at least one polymer (abstract). Loira Pastoriza et al. disclose the term consisting of at least a first amorphous phase and possibly a second crystalline phase means that said protoberberine alkaloid may comprise either 100 % amorphous phase by mass, or consist of both a first amorphous phase and a second crystalline phase, the sum of the percentage masses of said first and second phases amounting in this case to 100 (page 6, lines 19-27). The composition can consist of 50-100 % by mass amorphous phase and 0-50 % of a crystalline phase (page 8, lines 1-10). The protoberberine alkaloid includes berberine (col. 8, lines 10-col. 9, line 1). The polymer include celluloses and oligosaccharides such as chitosans (page 9, lines 3-18). The composition further includes at least one plasticizing agent which further enhances the alkaloids solubility and bioavailability (col. 9, lines 25-30). The plasticizing agent is selected from polyols, lipids, lechitins, sucrose esters, triethyl citrate, polyethylene glycol, glycerol, dibutyl sebate, butyl stearate, glycerol monostearate, diethyl phthalate and mixtures thereof (page 10, lines 13-16). The compositions further include one additive selected from lubricants, surfactants, antioxidants, chelating agents and mixtures thereof (page 10, lines 19-21). Loira Pastoriza et al. disclose advantageously, the composition also contains at least one first additional active phenolic-type substance selected from phenolic acids, stilbenes, phenolic alcohols, lignanes, flavonoids and mixtures thereof (page 11, lines 7-12). The composition is present as pellets, granules, powders, effervescent or non-effervescent tablets, solutions, suspensions, gels, or any other suitable form compatible with administration to an animal or human (page 12, lines 12-16). The process of making the composition involves mixing together and in a extruder as well as hot melt extrusion (e.g., a thermoformed extrusion) (page 12, lines 19-30). Claim 19 is directed to intended use of the composition and does not further limit the structure of claim 1. The berberine may be present at 40 % (Fig 4, page 16). The composition is in the form of a powder where the berberine is blended with at least one polymer (homogenous).It is mixed in the same manner as claimed (hot melt extrusion) (Ex 1).
The specific combination of features claimed is disclosed within the broad generic ranges taught by the reference but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989).
However, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have selected various combinations of the various disclosed protoberberine alkaloid and polymers (e.g., oligosaccharides) to arrive at compositions yielding no more than one would expect from such an arrangement.
The differences are that the Loira Pastoriza et al. does not disclose the same polymer of natural or synthetic origin as claimed, for example collagens or that the collagens have a molecular weight of between 50 and 300, Da.
Hao et al. (US 20070254035) (hereinafter Hao et al.) disclose preparing active polymer extrudates with guest matter where the guest matter is inclusive of a drug (abstract and para 0001). The extruder comprises a heating means thus would be considered thermoformed (para 0051). The extrusion can be conducted with polymers of molecular weights from 1 to 10,000 Kda (para 0032). 1 kda is equal to 1,000 Da and thus overlaps with the claimed daltons. Hao et al. disclose that we have now surprisingly found that by selection of higher molecular weight the polymer in the range as hereinbefore defined and preferably in the range 1 to 1000 kDa, more preferably 1 to 500 kDa, more preferably 1 to 250 kDa, more preferably 1 to 200 kDa, for example 1 to 50 or 50 to 200 kDa, more preferably 1 to 150 kDa, for example 1 to 30 or 30 to 150 kDa polymer substrate is suited both to incorporation of guest matter and to formation of extrudates (para 0032). Suitably a polymer substrate is selected for which the internal cohesive force between the molecules is strong enough to overcome the break up of material during the extrusion process. Hao et al. disclose accordingly polymer having strong internal cohesive forces may be employed at lower molecular weight in the above range and polymer having weaker internal cohesive force may be employed at higher molecular weight in the above range (para 0032). Hao et al. further teach that the molecular weight affects the morphology of the extrudates (para 0033). The polymers include cellulose or collagens (paras 0055-0066). The polymers may also include polypeptides and proteins.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have the polymer of Loira Pastoriza et al. include collagen, proteins or polypeptides as disclosed in Hao et al. One would have been motivated to do so because Hao et al. is concerned with incorporating guest matter (drugs inclusive of antimicrobials) into these polymers forming extrudates. Hao et al. demonstrates that these polymers include cellulose or collagens thus recognizes that these are both suitable choice polymers for incorporation of drugs. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to substitute the cellulose of Loira Pastoriza et al. for the collagen in Hao et al. Hao et al. recognizes selection of higher molecular weight polymer substrate is suited both to incorporation of guest matter and to formation of extrudates (para 0032). 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).
The modified Loira Pastoriza et al. disclose sustained release polymers but does not disclose pea protein. Parcq et al. (US 20230233686) (hereinafter Parcq et al.) disclose use of crosslinked pea dextrin for sustained release of active ingredients (paras 0020 and 0057). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use pea dextrin as the polymer in Loira Pastoriza et al. One would have been motivated to do so because it provides for sustained release for the active ingredients. While the solubility rate is not discloses, the combined teaching of the prior art arrives at the same structure as claimed and thus the solubility rate would necessarily follow.
DOUBLE PATENTING
5. 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, 5-12, 19 and 21-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 13-14 of copending Application No. 18541626. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to thermoformed extrudate with the same polymers that overlap the differences being that the instant application disclose protoberberine alkaloid whereas the ‘626 application discloses N-alkylamides such as piperine. These are both poorly water soluble drugs and it is prima facie obvious to substitute the instant drug (e.g., berberine) in the ‘626 application. Both are art recognized antibiotics (para 0018 or US 20200338016).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 5-12,19 and 21-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 18031576. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to thermoformed extrudate with the same polymers that overlap the differences being that the instant application disclose protoberberine alkaloid whereas the ‘576 application discloses labdane diterpene such as andrographolide. These are both poorly water soluble drugs and it is prima facie obvious to substitute the instant drug (e.g., berberine) in the ‘576 application. Both are art recognized for use as antimicrobials in treatment of an infectious disease in an animal (see pages 8 and 26 of WO 2018/176093).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 5-12, 19 and 21-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16, 23-24 of copending Application No. 17622128. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to thermoformed extrudate with the same polymers that overlap the differences being that the instant application disclose protoberberine alkaloid whereas the ‘128 application discloses at least one triterpene and/or at least one triterpenoid and/or a least one of the glycosylated forms thereof such as botulinic acid These are both poorly water soluble drugs and it is prima facie obvious to substitute the instant drug (e.g., berberine) in the ‘128 application. Both are art recognized for use as antimicrobials (see US 20160295858 para 0046).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
RESPONSE TO ARGUMENTS
6. Applicants argue that Hoa et al. teaches away from use of hot melt extrusion.
In response, the Examiner respectfully submits that the claimed process of hot melt is given little patentable weight as patentability of a product does not depend on the method. Additionally, the refence teaches that operation at higher temperatures is common practice in the art (paras 0013 and 0027). The reference teaches “in the processing of thermally labile fibres for use in dyeing, textiles, electronics etc below the polymer Tg, Tm or melt viscosity, in incorporation of dyes and other thermally labile materials into polymers that cannot be formed by traditional processes e.g. melt extrusion and the like” (para 0134). This is not a teaching away from use of the polymers as the reference states that operation at higher temperatures is common practice.
Applicants request the double patenting rejections be held in abeyance. Since no terminal disclaimer has been filed, the double patenting rejections are maintained.
CONCLUSION
7. 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.
CORRESPONDENCE
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANAH AL-AWADI/Primary Examiner, Art Unit 1615
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