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 .
The amendment filed 16 September 2026 is acknowledged and has been entered.
Claims 10, 17-18, 21-22, 24-34 and 36-47 have been cancelled.
Claims 1-9 and 35 have been withdrawn.
Claims 11-16, 19-20, 23 are presented for examination on the merits.
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.
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.
Claim(s) 11-16, 19-20, 23 stand rejected under 35 U.S.C. 103 as being unpatentable over Katti et al. (US2019/0255221) in view of Ilk et al. (2018) and any of Chu et al. (2014) or Chun et al. (2005) or Rodriguez-Perez et al.
Katti et al. beneficially disclose a scaffold composition comprising a biocompatible polymer and a clay. Preferably, the polymer is a natural polymer, synthetic polymer, blend, combination, or mixture of the same. Preferably, the clay comprises a smectite. Optionally, the scaffold can be coated in an additional ingredient such as amino acid, anesthetic, antibiotic, antiangiogenic agent, antibody, anticoagulant, antineoplastic agent, antiviral agent, biomaterial, bone morphogenetic proteins, carbohydrate, cell, cytotoxic agent, drug, electrolyte, growth factor, immunomodulator, inorganic material, lipid, mineral, oligonucleotide, osteoblast, osteoclast, osteo stem cell, polypeptide, progenitor, protein, therapeutic agent, tissue, tissue or cell aggregate, vasoactive agent, and combinations thereof.
Examples of natural polymers include proteins and polysaccharides, which can be used individually, in blends, combinations and/or mixtures. Preferred natural polymers, include, but are not limited to, albumin, alginate, cellulose (which is inclusive of regenerated cellulose), chitin, chitosan, collagen, gelatin, heparin, and other naturally occurring polymers such as regenerated silk or polysaccharide, and/or blends, combinations, or mixtures of the same.
Furthermore, the reference discloses:
[0089] Some of the optional ingredients can be prepared in a “biomimetic” manner in situ. For example, precursors to the desired optional ingredient can be added to the space between the clay sheets on the nanoscale so that an optional ingredient is formed between the sheets of clay. For example, amino acid molecules can be attached to the clay sheets to create HAP in a manner similar to the way HAP is naturally made in bones. This “biomimetic” in situ HAP-clay is morphologically and crystallographically identical to the natural HAP found in bones, while made in a synthetically engineered manner.
[0121] In addition to favorable cellular response indicated by the MTT and ALP assays, the formation of hierarchical mineralized fibrillar structures was also observed providing further evidence of biomineralization facilitated by vesicular delivery (FIG. 8C), which indicates a true bone-mimetic environment. Nanoindentation tests on the bone nodules reveal mechanical properties similar to human bone.
The cited reference does not explicitly disclose a phenolic phytochemical of plant extracts coating or impregnating the clay scaffold.
Ilk et al. (2018) beneficially teach combining a plant extract with chitosan/ODAMMT-based nanocomposite.
The cited references do not teach oregano, cranberry or Rhodiola extracts. However, each of these extracts are known to possess phenolic phytochemicals. For example:
Chu et al. beneficially teach that the extracts of R. crenulata have been madeinto pharmaceutical preparations and functional foods. Previous studies have demonstrated that the roots of R. crenulata possess beneficial properties, including the scavenging of active-oxygen species, anti-Alzheimer’s disease effects, and blood-glucose-lowering activity. In the previous phytochemical studies, more than 100 compounds were isolated from R. crenulata, including phenols, phenylpropanoids, phenylethanoids, flavonoids, monoterpenoids, cyanogens, and their corresponding glycosides.12 Among the isolated compounds, salidroside and p-tyrosol were the major bioactive constituents and showed antioxidant, antifatigue, and anti-inflammatory activities.
Chun et al. beneficially teach that phenolic phytochemicals have been shown to
have antimicrobial and antifungal activity. Oregano (Origanum vulgare L.) is an important Mediterranean herb rich in phenolic compounds with antioxidant and antimicrobial activity. Using tissue culture techniques several high phenolics and rosmarinic acid-containing oregano clonal lines have been isolated with high antioxidant activity with antimicrobial potential. In this investigation the antioxidant activity of
phenolic-enriched clonal oregano extracts, and their antimicrobial activity against ulcer-associated Helicobacter pylori have been evaluated.
Rodriguez-Perez et al. beneficially teach that phenolic compounds from a cranberry extract were isolated in order to assess their contribution to the antibacterial activity against uropathogenic strains of Escherichia coli (UPEC). With this purpose, a total of 25 fractions from a cranberry extract were isolated using semipreparative high performance liquid chromatography (HPLC) and characterized based on the results obtained by reversed-phase HPLC coupled to mass spectrometry detection. Then, the effects on UPEC surface hydrophobicity and biofilm formation of the cranberry extract as well as the purest fractions (a total of 13) were tested. As expected, the whole extract presented a powerful antibacterial activity against UPEC while the selected fractions presented a different behavior. Myricetin and quercitrin significantly decreased (p < 0.05) E. coli biofilm formation compared with the control, while dihydroferulic acid glucuronide, procyanidin A dimer, quercetin glucoside, myricetin and prodelphinidin B led to a significant decrease of the surface hydrophobicity compared with the control. The results suggest that apart from proanthocyanidins, other compounds, mainly flavonoids, can act against E. coli biofilm formation and also modify UPEC surface hydrophobicity in vitro, one of the first steps of adhesion.
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the Application to further include plant extracts containing phenolic phytochemicals from oregano, cranberry and/or Rhodiola within the clay scaffold taught by Katti et al. based upon the beneficial teachings provided by the cited references with respect to the antibacterial effects of the extracts. It would have been obvious to combine the instant ingredients for their known benefit since each is well known in the art for the same purpose and for the following reasons: each of the plant extracts is known to possess antibiotic activity. In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court reaffirmed "the conclusion that when 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." Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273,282 (1976)). The Supreme Court also emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 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." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton."). The Supreme Court thus implicitly endorsed the principle, stated in In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980) (citations omitted), that: It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art.
Accordingly, the instant claims, where no unexpected results are observed, would have been obvious to one of ordinary skill having the above cited references before him/her.
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 11-16, 19-20, 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,541,150 in view of any of Chu et al. (2014) or Chun et al. (2005) or Rodriguez-Perez et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to a composition a polymer and clay in the form of a scaffold and combining additional active ingredients. Such active ingredients can be in the form of phytochemicals such as taught by the cited references.
Response to Arguments
Applicant’s amendments/arguments, with respect to the 35 USC 112(b) rejections have been fully considered and are persuasive. The 35 USC 112(b) rejection of the previous Office action has been withdrawn.
Applicant's amendments/arguments filed with respect to the 35 USC 103 and ODP rejections have been fully considered but they are not persuasive.
Applicant has amended independent claim 11 to include bone mimetic scaffold, but such is already taught by the cited. Katti et al. reference.
It should be reiterated that the claims under examination are directed to a composition, not its intended use or a method of use. Thus, added language such as “the phenolic phytochemical induces apoptosis of cancer cells metastasized to bone and is not cytotoxic to healthy bone cells” does not effectively limit the claimed composition, but merely states an intrinsic property of the phenolic phytochemicals, all of which are recited in claims 13-16.
The claims remain broadly directed to the a scaffold, which is taught by the previous Katti patent in which phenolic phytochemicals are incorporated. This incorporation is known in the prior art as is the specific phytochemicals from the recited botanicals.
Applicant asserts that the present application provides experimental evidence that the phytochemicals selectively induce apoptosis in cancer cells metastasized to bone without cytotoxicity to healthy bone cells. Example 2 beginning at paragraph [0127] of the specification as originally filed demonstrates that R. crenulata reduced proliferation of MCF-7 and MM231 breast cancer cells cultured in the 3D bone-metastatic testbed, while healthy bone cells treated with the same concentrations, including up to 800 ppm, exhibited no reduction in viability and were confirmed by live/dead staining to remain unaffected. See paragraphs [0130]-[0132]. Flow cytometry further demonstrated increased apoptosis in the treated 3D bone-metastatic cultures, and caspase-3 and caspase-9 were significantly upregulated in the bone-metastatic breast cancer cells. See paragraphs [0133] and [0137]. In contrast, treatment of healthy bone cells produced no significant change in pro- or anti-apoptotic biomarkers, further demonstrating that the apoptotic response was selective for the cancer cells in the bone-metastatic environment. See paragraphs [0136] and [0140]. Example 4 beginning at paragraph [0164] of the specification as originally filed goes on to demonstrate the same selective effect for the oregano and cranberry extracts. Both reduced viability and induced apoptosis in 3D bone-metastatic breast cancer cultures, including significant activation of caspase-3 and caspase-9, whereas healthy bone cells showed no reduction in viability and no significant changes in apoptotic markers. See paragraphs [0176]-[0184] and [0189]. This selective induction of apoptosis in cancer cells metastasized to bone without cytotoxicity to healthy bone cells is unexpected in view of the cited references.
However, with respect to such unexpected results, please note that in KSR, the Court also reaffirmed that evidence of unexpected results may overcome an examiner's prima facie case of obviousness. KSR, 550 U.S. at 416 ("The fact that the elements worked together in an unexpected and fruitful manner supported the conclusion that Adams' design was not obvious to those skilled in the art" - discussing United States v. Adams, 383 U.S. 39). However, "any superior property must be unexpected to be considered as evidence of non-obviousness." Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007). Thus, "[m]ere improvement in properties does not always suffice to show unexpected results ....[W]hen an applicant demonstrates substantially improved results.., and states that the results were unexpected, this should suffice to establish unexpected results in the absence of evidence to the contrary." In re Soni, 54 F.3d 746, 751 (Fed. Cir. 1995). Moreover, in order to establish unexpected results for claimed invention, objective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support. In re Greenfield, 571 F.2d 1185, 1189 (CCPA 1978). Please also note that "the discovery of an optimum value of a variable in a known process is usually obvious." Pfizer v. Apotex, 480 F.3d at 1368. The rationale for determining the optimal parameters for prior art result effective variables "flows from the 'normal desire of scientists or artisans to improve upon what is already generally known.'" Id. (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)).
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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL G FIEBIG whose telephone number is (571)270-5366. The examiner can normally be reached M-F 8-4.
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, Anand Desai can be reached at 5712720947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RUSSELL G FIEBIG/Examiner, Art Unit 1655
Prosecution Insights