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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/27/2026 has been entered.
Response to Amendment
Applicant has amended claims 1 and 9 and cancelled claims 14-15. Claims 1, 3-4, and 7-13 remain pending.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Bermudez-Bejarano et al. (Bermúdez-Bejarano EB, Serrera-Figallo MA, Gutiérrez-Corrales A, Romero-Ruiz MM, Castillo-de-Oyagüe R, Gutiérrez-Pérez JL, Torres-Lagares D. Prophylaxis and antibiotic therapy in management protocols of patients treated with oral and intravenous bisphosphonates. J Clin Exp Dent. 2017;9(1):e141-9., henceforth Bermudez-Bejarano, previously made of record) in view of De Ceulaer et al. (De Ceulaer J, Tacconelli E, Vandecasteele SJ. Actinomyces osteomyelitis in bisphosphate-related osteonecrosis of the jaw (BRONJ): the missing link? Eur J Clin Microbiol Infect Dis. 2014; 33:1873-1880., henceforth De Ceulaer), Lynch (US 20130108683, henceforth Lynch, previously made of record), Briscoe (US 20190038297, henceforth Briscoe), Yang (US 20210330425, henceforth Yang), and as evidenced by Buonavoglia et al. (Buonavoglia, A.; Leone, P.; Solimando, A.G.; Fasano, R.; Malerba, E.; Prete, M.; Corrente, M.; Prati, C.; Vacca, A.; Racanelli, V. Antibiotics or No Antibiotics, That Is the Question: An Update on Efficient and Effective Use of Antibiotics in Dental Practice. Antibiotics 2021, 10, 550., henceforth Buonavoglia, previously made of record).
Regarding claim 1, Bermudez-Bejarano discloses a method of treating osteonecrosis of jaws (see Abstract), consisting essentially of: administering surgery (“conservative treatment may be accompanied by surgical treatments with varying levels of invasiveness”, pg. e148, left column, second paragraph); and administering an antibiotic treatment (see pgs. e144, e145) to the patient for one week prior to the surgery (“antibiotics should be prescribed three (14) or seven (15) days before tooth extraction”, pg. e145, left column, last paragraph demonstrates that it was known to use antibiotics for seven days prior to a surgery) and two weeks after the surgery (“post-extraction recommendations vary, with articles suggesting that antibiotic prophylaxis be administered anywhere from seven (15) to seventeen days (14) post-intervention”, pg. e145, right column, first paragraph), the antibiotic treatment consisting essentially of administering a first antibiotic (amoxicillin and clavulanic acid, see third row of Table 1 on pg. e145 regarding the Saia et al. study) targeting broad spectrum bacteria (see pg. e148, amoxicillin is commonly used because “broad spectrum antibiotics can be used in cases where MRONJ must be treated as soon as possible”) twice daily (see third row of Table 1 on pg. e145 regarding the Saia et al. study, amoxicillin and clavulanic acid is prescribed in 1g doses every 12 hours, or twice daily, see also the first note below) and a second antibiotic (“add metronidazole”, pg. e147, left column, first paragraph, see also the third row of Table 1 on pg. e145 regarding the Saia et al. study which also includes metronidazole) three times a day (see third row of Table 1 on pg. e145 regarding the Saia et al. study, metronidazole is prescribed in 500mg doses every 8 hours, or three times a day).
{Examiner further notes that the exact dosed amount of a given antibiotic is within the scope of a determination of one of ordinary skill in the art; Bermudez-Bejarano discloses that different dosages of amoxicillin and clavulanic acid can be used effectively as shown in the “Guidelines for antibiotic prophylaxis” column of Table 1. Thus, the exact dosage of metronidazole to be administered to the patient is a result effective variable which one of ordinary skill in the art would have been able to determine to best treat osteomyelitis, which further renders the claimed dosing regimen obvious. Applicant has also provided no criticality to the exact dosing schedule or unexpected results from the exact dosing schedule (see [0011] from Applicant’s Specification, “The dual antibiotic therapy can include administering Augmentin (e.g., 1 g twice daily) and Metronidazole (e.g., 400 mg three times a day)”, which does not indicate criticality of the claimed prescriptions).}
Bermudez-Bejarano does not explicitly disclose that it is treating osteomyelitis. De Ceulaer teaches that osteonecrosis must be considered as osteomyelitis of the jaw (see pg. 1878, Summary section, point 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have treated osteomyelitis with the antibiotic administration of Bermudez-Bejarano as De Ceulaer teaches that osteonecrosis is a part of osteomyelitis and thus that treatment of osteonecrosis is treatment of osteomyelitis.
{Examiner notes that De Ceulaer and Bermudez-Bejarano refer to osteonecrosis of the jaws using different abbreviations, BRONJ and MRONJ, respectively; these are the same condition which had its name/abbreviation changed over time, but the teachings for either one of them apply to both of them. An additional evidentiary reference pointing out this name change is provided in the Conclusion section of the Office Action from 01/27/2026.}
Bermudez-Bejarano as modified discloses the method of treating osteonecrosis is the method of treating osteomyelitis (see modification with De Ceulaer above). Examiner notes that osteonecrosis is, by definition, localized death of living bone.
Bermudez-Bejarano as modified does not explicitly disclose the method comprising administering surgery to remove necrotic bone and create bleeding spots in an affected area of a patient’s jaw as claimed. Lynch teaches a method of treating oral injuries including osteomyelitis ([0004]) and necrotizing infections (see at least [0004], [0010], and [0013]) where the method comprises administering surgery to remove necrotic bone (see [0006] and [0144]) and create bleeding spots in an affected area of target tissue ([0144], intramarrow bone penetrations are performed to produce bleeding bone).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have followed the surgical steps of Lynch to treat osteomyelitis including osteonecrosis, which is an oral injury, as in Bejarano-Bermudez as modified for the benefit of promoting healing of damaged tissue at the site of a wound (Lynch [0141]) and because the surgical steps of debridement and creating bleeding were known procedures at the time (Lynch [0006]).
Bermudez-Bejarano as modified does not disclose that the surgery is a piezoelectric surgery which consists essentially of administering ultrasonic vibrations with a frequency ranging from about 25 to 29 kHz which is translated and amplified onto inserts resulting in linear micro-vibrations. Briscoe teaches piezoelectric surgery done on bone such as jaws (see [0012], the piezoelectric device can be used in a surgery for treatment of jaws of a subject) consisting essentially of administering ultrasonic vibrations (see [0015] and see [0020], ultrasonic vibrations are used for the cutting of bone in dental surgery and implantation) with a frequency ranging from about 25 to 29 kHz (see [0020], a range of 20-30 kHz is taught to be used for cutting bone which is sufficiently specific as to teach the claimed range of 25-29 kHz as the ultrasonic vibrations of Briscoe and in the instant application are used for the same purpose and because Applicant has not indicated criticality of the claimed range, particularly where Applicant’s Specification refers to a range of about 25-29 kHz at [0012]) which is translated and amplified onto inserts (cutting insert of [0009]-[0011]) resulting in linear micro-vibrations (ultrasound frequency vibrations as in [0011]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the piezoelectric device of Briscoe for the surgery of Bermudez-Bejarano as modified since the limited range of ultrasonic frequencies used by the device of Briscoe prevents soft tissues from being damaged but is used for the cutting of bone in dental procedures (see Briscoe [0003], [0004], and [0026]).
Bermudez-Bejarano as modified does not disclose the method wherein the linear micro-vibrations are in a range of 60 µm to 200 µm as claimed. Yang teaches that ultrasonic vibrations in piezoelectric surgeries can have an amplitude in the range of 1-1000 µm ([0096]). Yang additionally teaches that characteristics of a piezoelectric device or surgery can be modified for a desired clinical application ([0096] “The rotation speed of files can be automatically changed according to the design of pattern and clinical applications”, while the exact quote is given for rotation speed of a file it is understood that the same teaching would apply for ultrasonic vibrations as well since both piezoelectric devices are listed as equivalents and since the conditions for optimization would be the same; Examiner additionally notes that Applicant has not shown any criticality to the claimed range, particularly shown in Applicant’s Specification at [0012] where it is stated that the vibrations are in a range of about 60 µm to 200 µm, and additionally no unexpected results are shown at this vibration amplitude).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have set the inserts of the piezoelectric device of Briscoe to vibrate in the claimed range as Yang teaches this range to be known in the art of piezoelectric surgeries and further because it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Bermudez-Bejarano does not explicitly disclose that the first antibiotic targets β-lactam and broad spectrum bacteria, or that the second antibiotic targets anaerobic bacteria. Buonavoglia evidences that a first antibiotic (amoxicillin, see Table 1 on pg. 3 and “first choice antibiotics … are usually broad-spectrum molecules [12], such as betalactams [such as] amoxicillin”, pg. 3 par. 3) targets β-lactam and broad spectrum bacteria (“broad-spectrum molecules [12], such as betalactams [such as] amoxicillin … in combination with clavunalate”, pg. 3 par. 3 – Examiner notes that clavunalate in Buonavoglia is understood to be a typographical error for clavulanate, which is the salt form of clavulanic acid as in Bermudez-Bejarano) and a second antibiotic (metronidazole, pg. 4 par. 6) targets anaerobic bacteria (“Another antibiotic widely used for pharmacological treatment of periodontal diseases is metronidazole, due to its efficacy against anaerobes”, pg. 4 par. 6).
Since Buonavoglia evidences that the first antibiotic, which is amoxicillin and clavulanic acid as in Bermudez-Bejarano, targets β-lactam and broad spectrum bacteria, and that the second antibiotic, which is metronidazole as in Bermudez-Bejarano, targets anaerobic bacteria, it is understood that these claim limitations are inherent to Bermudez-Bejarano since the called out antibiotics are the same and thus what they target is their inherent nature.
Regarding claim 3, Bermudez-Bejarano as modified discloses the method wherein 1 gram of the first antibiotic is administered twice daily (see third row of Table 1 on pg. e145 regarding the Saia et al. study, amoxicillin and clavulanic acid is prescribed in 1g doses every 12 hours, or twice daily).
{Examiner further notes that the exact dosed amount of a given antibiotic is within the scope of a determination of one of ordinary skill in the art; Bermudez-Bejarano discloses that different dosages of amoxicillin and clavulanic acid can be used effectively as shown in the “Guidelines for antibiotic prophylaxis” column of Table 1. Thus, the exact dosage of metronidazole to be administered to the patient is a result effective variable which one of ordinary skill in the art would have been able to determine to best treat osteomyelitis, which further renders the claimed dosing regimen obvious. Applicant has also provided no criticality to the exact dosing schedule or unexpected results from the exact dosing schedule (see [0011] from Applicant’s Specification, “The dual antibiotic therapy can include administering Augmentin (e.g., 1 g twice daily) and Metronidazole (e.g., 400 mg three times a day)”, which does not indicate criticality of the claimed prescriptions).}
Regarding claim 4, Bermudez-Bejarano as modified discloses the method wherein 500 mg of the second antibiotic is administered three times a day (see third row of Table 1 on pg. e145 regarding the Saia et al. study, metronidazole is prescribed in 500mg doses every 8 hours, or three times a day).
While Bermudez-Bejarano does not explicitly disclose the method wherein 400 mg of the second antibiotic is administered three times a day as claimed, the exact dosed amount of a given antibiotic is within the scope of a determination of one of ordinary skill in the art; Bermudez-Bejarano discloses that different dosages of metronidazole can be used effectively as shown in the “Guidelines for antibiotic prophylaxis” column of Table 1. Thus, the exact dosage of metronidazole to be administered to the patient is a result effective variable which one of ordinary skill in the art would have been able to determine to best treat osteomyelitis, which renders the claimed dosing regimen obvious, and since metronidazole is disclosed in Bermudez-Bejarano as being administered in doses higher and lower than those claimed (Table 2 col. 2 on pg. e145 discloses a metronidazole dose of 1g/day, which would be a dosage of 333mg three times daily; the third row of Table 1 on pg. e145 regarding the Saia et al. study discloses metronidazole prescribed in 500mg doses three times a day), it is understood that this range is within the range disclosed in prior art. Applicant has also provided no criticality to the exact dosing schedule or unexpected results from the exact dosing schedule (see [0011] from Applicant’s Specification, “The dual antibiotic therapy can include administering Augmentin (e.g., 1 g twice daily) and Metronidazole (e.g., 400 mg three times a day)”, which does not indicate criticality of the claimed prescriptions).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Bermudez-Bejarano et al. (Bermúdez-Bejarano EB, Serrera-Figallo MA, Gutiérrez-Corrales A, Romero-Ruiz MM, Castillo-de-Oyagüe R, Gutiérrez-Pérez JL, Torres-Lagares D. Prophylaxis and antibiotic therapy in management protocols of patients treated with oral and intravenous bisphosphonates. J Clin Exp Dent. 2017;9(1):e141-9., henceforth Bermudez-Bejarano) in view of De Ceulaer et al. (De Ceulaer J, Tacconelli E, Vandecasteele SJ. Actinomyces osteomyelitis in bisphosphate-related osteonecrosis of the jaw (BRONJ): the missing link? Eur J Clin Microbiol Infect Dis. 2014; 33:1873-1880., henceforth De Ceulaer), Lynch (US 20130108683, henceforth Lynch), Briscoe (US 20190038297, henceforth Briscoe), Yang (US 20210330425, henceforth Yang), and as evidenced by Buonavoglia et al. (Buonavoglia, A.; Leone, P.; Solimando, A.G.; Fasano, R.; Malerba, E.; Prete, M.; Corrente, M.; Prati, C.; Vacca, A.; Racanelli, V. Antibiotics or No Antibiotics, That Is the Question: An Update on Efficient and Effective Use of Antibiotics in Dental Practice. Antibiotics 2021, 10, 550., henceforth Buonavoglia) as applied to claim 1 above, and further in view of Balanger et al. (Balanger M, Hinet M, Vacher C, Bellaiche N, Charrier JL, Millot S. Osteomyelitis of the Mandible after Dental Implants in an Immunocompetent Patient. Case Rep Dent. 2017;2017:9525893. doi: 10.1155/2017/9525893. Epub 2017 Apr 2. PMID: 28469945; PMCID: PMC5392388., henceforth Balanger, previously made of record).
Regarding claim 7, Bermudez-Bejarano as modified discloses the presence of osteomyelitis of the jaws (see the rejection of claim 1 regarding De Ceulaer).
Bermudez-Bejarano as modified does not disclose that the osteomyelitis of the jaws is caused by a prior dental implant and the affected area includes a site of the prior dental implant. Balanger teaches that osteomyelitis was known to be caused by dental implants (see pg. 2, left column, second paragraph and pg. 2, right column, second paragraph) and that such osteomyelitis results in an infected, necrotic affected area including the site of said dental implants (see pg. 1, left column, second paragraph, necrosis of tissues in osteomyelitis is known).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the osteomyelitis treatment method of Bermudez-Bejarano as modified to affected areas which were caused by prior dental implants as in Balanger, as these implant areas were known to cause osteomyelitis and as Balanger teaches that it is important to identify osteomyelitis especially when it is near a dental implant area such that the dental practitioner can accurately determine whether removal of the implant is necessary for successful treatment (Balanger pg. 1, right column, first paragraph).
Regarding claim 8, Bermudez-Bejarano as modified discloses the presence of osteomyelitis of the jaws (see the rejection of claim 1 above regarding De Ceulaer).
Bermudez-Bejarano as modified does not disclose that the osteomyelitis of the jaws is secondary osteomyelitis of the jaws. Balanger teaches that chronic osteomyelitis was known to be caused by dental implants (see pg. 2, left column, second paragraph and pg. 2, right column, second paragraph) and that such chronic osteomyelitis results in an infected, necrotic affected area including the site of said dental implants (see pg. 1, left column, second paragraph, necrosis of tissues in osteomyelitis is known). {Examiner notes that chronic osteomyelitis includes secondary osteomyelitis when there is an abscess during sequestration as indicated by Applicant’s specification in [0004], and there was an abscess as indicated in pg. 3, right column, first paragraph.}
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the osteomyelitis treatment method of Bermudez-Bejarano as modified to affected areas which were caused by prior dental implants as in Balanger, as these implant areas were known to cause chronic osteomyelitis and as Balanger teaches that it is important to identify chronic osteomyelitis especially when it is near a dental implant area such that the dental practitioner can accurately determine whether removal of the implant is necessary for successful treatment (Balanger pg. 1, right column, first paragraph).
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bermudez-Bejarano et al. (Bermúdez-Bejarano EB, Serrera-Figallo MA, Gutiérrez-Corrales A, Romero-Ruiz MM, Castillo-de-Oyagüe R, Gutiérrez-Pérez JL, Torres-Lagares D. Prophylaxis and antibiotic therapy in management protocols of patients treated with oral and intravenous bisphosphonates. J Clin Exp Dent. 2017;9(1):e141-9., henceforth Bermudez-Bejarano) in view of De Ceulaer et al. (De Ceulaer J, Tacconelli E, Vandecasteele SJ. Actinomyces osteomyelitis in bisphosphate-related osteonecrosis of the jaw (BRONJ): the missing link? Eur J Clin Microbiol Infect Dis. 2014; 33:1873-1880., henceforth De Ceulaer), Lynch (US 20130108683, henceforth Lynch), Briscoe (US 20190038297, henceforth Briscoe), Yang (US 20210330425, henceforth Yang), and Buonavoglia et al. (Buonavoglia, A.; Leone, P.; Solimando, A.G.; Fasano, R.; Malerba, E.; Prete, M.; Corrente, M.; Prati, C.; Vacca, A.; Racanelli, V. Antibiotics or No Antibiotics, That Is the Question: An Update on Efficient and Effective Use of Antibiotics in Dental Practice. Antibiotics 2021, 10, 550., henceforth Buonavoglia).
Regarding claim 9, Bermudez-Bejarano discloses a method of treating osteonecrosis of jaws (see Abstract), consisting essentially of: administering surgery (“conservative treatment may be accompanied by surgical treatments with varying levels of invasiveness”, pg. e148, left column, second paragraph); and administering an antibiotic treatment (see pgs. e144, e145) to the patient for one week prior to the surgery (“antibiotics should be prescribed three (14) or seven (15) days before tooth extraction”, pg. e145, left column, last paragraph demonstrates that it was known to use antibiotics for seven days prior to a surgery) and two weeks after the surgery (“post-extraction recommendations vary, with articles suggesting that antibiotic prophylaxis be administered anywhere from seven (15) to seventeen days (14) post-intervention”, pg. e145, right column, first paragraph), the antibiotic treatment including a first antibiotic (amoxicillin and clavulanic acid, see third row of Table 1 on pg. e145 regarding the Saia et al. study) targeting broad spectrum bacteria (see pg. e148, amoxicillin is commonly used because “broad spectrum antibiotics can be used in cases where MRONJ must be treated as soon as possible”) twice daily (see third row of Table 1 on pg. e145 regarding the Saia et al. study, amoxicillin and clavulanic acid is prescribed in 1g doses every 12 hours, or twice daily, see also the first note below) and a second antibiotic (“add metronidazole”, pg. e147, left column, first paragraph, see also the third row of Table 1 on pg. e145 regarding the Saia et al. study which also includes metronidazole) three times daily (see third row of Table 1 on pg. e145 regarding the Saia et al. study, metronidazole is prescribed in 500mg doses every 8 hours, or three times a day).
{Examiner further notes that the exact dosed amount of a given antibiotic is within the scope of a determination of one of ordinary skill in the art; Bermudez-Bejarano discloses that different dosages of amoxicillin and clavulanic acid can be used effectively as shown in the “Guidelines for antibiotic prophylaxis” column of Table 1. Thus, the exact dosage of metronidazole to be administered to the patient is a result effective variable which one of ordinary skill in the art would have been able to determine to best treat osteomyelitis, which further renders the claimed dosing regimen obvious. Applicant has also provided no criticality to the exact dosing schedule or unexpected results from the exact dosing schedule (see [0011] from Applicant’s Specification, “The dual antibiotic therapy can include administering Augmentin (e.g., 1 g twice daily) and Metronidazole (e.g., 400 mg three times a day)”, which does not indicate criticality of the claimed prescriptions).}
Bermudez-Bejarano does not explicitly disclose that it is treating osteomyelitis. De Ceulaer teaches that osteonecrosis must be considered as osteomyelitis of the jaw (see pg. 1878, Summary section, point 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have treated osteomyelitis with the antibiotic administration of Bermudez-Bejarano as De Ceulaer teaches that osteonecrosis is a part of osteomyelitis and thus that treatment of osteonecrosis is treatment of osteomyelitis.
{Examiner notes that De Ceulaer and Bermudez-Bejarano refer to osteonecrosis of the jaws using different abbreviations, BRONJ and MRONJ, respectively; these are the same condition which had its name/abbreviation changed over time, but the teachings for either one of them apply to both of them. An additional evidentiary reference pointing out this name change is provided in the Conclusion section of the Office Action from 01/27/2026.}
Bermudez-Bejarano as modified discloses the method of treating osteonecrosis is the method of treating osteomyelitis (see modification with De Ceulaer above). Examiner notes that osteonecrosis is, by definition, localized death of living bone.
Bermudez-Bejarano as modified does not explicitly disclose the method comprising administering surgery to remove necrotic bone and create bleeding spots in an affected area of a patient’s jaw as claimed. Lynch teaches a method of treating oral injuries including osteomyelitis ([0004]) and necrotizing infections (see at least [0004], [0010], and [0013]) where the method comprises administering surgery to remove necrotic bone (see [0006] and [0144]) and create bleeding spots in an affected area of target tissue ([0144], intramarrow bone penetrations are performed to produce bleeding bone).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have followed the surgical steps of Lynch to treat osteomyelitis, which is an oral injury, as in Bejarano-Bermudez as modified for the benefit of promoting healing of damaged tissue at the site of a wound (Lynch [0141]) and because the surgical steps of debridement and creating bleeding were known procedures at the time (Lynch [0006]).
Bermudez-Bejarano as modified does not explicitly disclose the method of treating osteomyelitis of the jaws comprising: excising of fistula and curettage of granulation tissue from an affected area of a patient’s jaw. Buonavoglia teaches excising of fistula and curettage of granulation tissue prior to administering surgery (Buonavoglia pg. 14 discloses that as a part of a surgical procedure, removing of bacteria or debris is present, as well as removal of granulation tissue, and occasionally leaving surgical flaps; it is the Examiner’s position that this constitutes appropriate cleaning of a wounded area and preoperative treatment thereof, and that if fistula were present as a part of the debris of the wounded area, it would be removed or excised, and that the curettage of granulation tissue as claimed is the same thing as the taught removal of granulation tissue).
It would have further been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include excision of fistula, curettage of granulation tissue, removal of necrotic bone, irrigation of dry sockets, curettage of bone plates, and any other needed extractions as in Buonavoglia to the oral surgery of Bermudez-Bejarano as Buonavoglia teaches these to be steps involved in the treatment of oral injuries which are completed as is needed on a case-by-case basis (surgical curettage is needed in treatment of dry sockets as in pg. 14 par. 2 as part of atraumatic surgical technique, but this is not always the case) and further since it is understood that it would be within the skill of one with ordinary skill in the art to have appropriately completed the surgery to address all anatomical issues as a part of the osteomyelitis.
Bermudez-Bejarano as modified does not disclose that the surgery is a piezoelectric surgery which comprises administering ultrasonic vibrations with a frequency ranging from about 25 to 29 kHz which is translated and amplified onto inserts resulting in linear micro-vibrations. Briscoe teaches piezoelectric surgery done on bone such as jaws (see [0012], the piezoelectric device can be used in a surgery for treatment of jaws of a subject) consisting essentially of administering ultrasonic vibrations (see [0015] and see [0020], ultrasonic vibrations are used for the cutting of bone in dental surgery and implantation) with a frequency ranging from about 25 to 29 kHz (see [0020], a range of 20-30 kHz is taught to be used for cutting bone which is sufficiently specific as to teach the claimed range of 25-29 kHz as the ultrasonic vibrations of Briscoe and in the instant application are used for the same purpose and because Applicant has not indicated criticality of the claimed range, particularly where Applicant’s Specification refers to a range of about 25-29 kHz at [0012]) which is translated and amplified onto inserts (cutting insert of [0009]-[0011]) resulting in linear micro-vibrations (ultrasound frequency vibrations as in [0011]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the piezoelectric device of Briscoe for the surgery of Bermudez-Bejarano as modified since the limited range of ultrasonic frequencies used by the device of Briscoe prevents soft tissues from being damaged but is used for the cutting of bone in dental procedures (see Briscoe [0003], [0004], and [0026]).
Bermudez-Bejarano as modified does not disclose the method wherein the linear micro-vibrations are in a range of 60 µm to 200 µm as claimed. Yang teaches that ultrasonic vibrations in piezoelectric surgeries can have an amplitude in the range of 1-1000 µm ([0096]). Yang additionally teaches that characteristics of a piezoelectric device or surgery can be modified for a desired clinical application ([0096] “The rotation speed of files can be automatically changed according to the design of pattern and clinical applications”, while the exact quote is given for rotation speed of a file it is understood that the same teaching would apply for ultrasonic vibrations as well since both piezoelectric devices are listed as equivalents and since the conditions for optimization would be the same; Examiner additionally notes that Applicant has not shown any criticality to the claimed range, particularly shown in Applicant’s Specification at [0012] where it is stated that the vibrations are in a range of about 60 µm to 200 µm, and additionally no unexpected results are shown at this vibration amplitude).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have set the inserts of the piezoelectric device of Briscoe to vibrate in the claimed range as Yang teaches this range to be known in the art of piezoelectric surgeries and further because it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Bermudez-Bejarano does not explicitly disclose that the first antibiotic targets β-lactam and broad spectrum bacteria, or that the second antibiotic targets anaerobic bacteria. Buonavoglia evidences that a first antibiotic (amoxicillin, see Table 1 on pg. 3 and “first choice antibiotics … are usually broad-spectrum molecules [12], such as betalactams [such as] amoxicillin”, pg. 3 par. 3) targets β-lactam and broad spectrum bacteria (“broad-spectrum molecules [12], such as betalactams [such as] amoxicillin … in combination with clavunalate”, pg. 3 par. 3 – Examiner notes that clavunalate in Buonavoglia is understood to be a typographical error for clavulanate, which is the salt form of clavulanic acid as in Bermudez-Bejarano) and a second antibiotic (metronidazole, pg. 4 par. 6) targets anaerobic bacteria (“Another antibiotic widely used for pharmacological treatment of periodontal diseases is metronidazole, due to its efficacy against anaerobes”, pg. 4 par. 6).
Since Buonavoglia evidences that the first antibiotic, which is amoxicillin and clavulanic acid as in Bermudez-Bejarano, targets β-lactam and broad spectrum bacteria, and that the second antibiotic, which is metronidazole as in Bermudez-Bejarano, targets anaerobic bacteria, it is understood that these claim limitations are inherent to Bermudez-Bejarano since the called out antibiotics are the same and thus what they target is their inherent nature.
Regarding claim 10, Bermudez-Bejarano as modified discloses the method wherein 1 gram of the first antibiotic is administered twice daily (see third row of Table 1 on pg. e145 regarding the Saia et al. study, amoxicillin and clavulanic acid is prescribed in 1g doses every 12 hours, or twice daily).
{Examiner further notes that the exact dosed amount of a given antibiotic is within the scope of a determination of one of ordinary skill in the art; Bermudez-Bejarano discloses that different dosages of amoxicillin and clavulanic acid can be used effectively as shown in the “Guidelines for antibiotic prophylaxis” column of Table 1. Thus, the exact dosage of metronidazole to be administered to the patient is a result effective variable which one of ordinary skill in the art would have been able to determine to best treat osteomyelitis, which further renders the claimed dosing regimen obvious. Applicant has also provided no criticality to the exact dosing schedule or unexpected results from the exact dosing schedule (see [0011] from Applicant’s Specification, “The dual antibiotic therapy can include administering Augmentin (e.g., 1 g twice daily) and Metronidazole (e.g., 400 mg three times a day)”, which does not indicate criticality of the claimed prescriptions).}
Regarding claim 11, Bermudez-Bejarano as modified discloses the method wherein 500 mg of the second antibiotic is administered three times a day (see third row of Table 1 on pg. e145 regarding the Saia et al. study, metronidazole is prescribed in 500mg doses every 8 hours, or three times a day).
While Bermudez-Bejarano does not explicitly disclose the method wherein 400 mg of the second antibiotic is administered three times a day as claimed, the exact dosed amount of a given antibiotic is within the scope of a determination of one of ordinary skill in the art; Bermudez-Bejarano discloses that different dosages of metronidazole can be used effectively as shown in the “Guidelines for antibiotic prophylaxis” column of Table 1. Thus, the exact dosage of metronidazole to be administered to the patient is a result effective variable which one of ordinary skill in the art would have been able to determine to best treat osteomyelitis, which renders the claimed dosing regimen obvious, and since metronidazole is disclosed in Bermudez-Bejarano as being administered in doses higher and lower than those claimed (Table 2 col. 2 on pg. e145 discloses a metronidazole dose of 1g/day, which would be a dosage of 333mg three times daily; the third row of Table 1 on pg. e145 regarding the Saia et al. study discloses metronidazole prescribed in 500mg doses three times a day), it is understood that this range is within the range disclosed in prior art. Applicant has also provided no criticality to the exact dosing schedule or unexpected results from the exact dosing schedule (see [0011] from Applicant’s Specification, “The dual antibiotic therapy can include administering Augmentin (e.g., 1 g twice daily) and Metronidazole (e.g., 400 mg three times a day)”, which does not indicate criticality of the claimed prescriptions).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Bermudez-Bejarano et al. (Bermúdez-Bejarano EB, Serrera-Figallo MA, Gutiérrez-Corrales A, Romero-Ruiz MM, Castillo-de-Oyagüe R, Gutiérrez-Pérez JL, Torres-Lagares D. Prophylaxis and antibiotic therapy in management protocols of patients treated with oral and intravenous bisphosphonates. J Clin Exp Dent. 2017;9(1):e141-9., henceforth Bermudez-Bejarano) in view of De Ceulaer et al. (De Ceulaer J, Tacconelli E, Vandecasteele SJ. Actinomyces osteomyelitis in bisphosphate-related osteonecrosis of the jaw (BRONJ): the missing link? Eur J Clin Microbiol Infect Dis. 2014; 33:1873-1880., henceforth De Ceulaer), Lynch (US 20130108683, henceforth Lynch), Briscoe (US 20190038297, henceforth Briscoe), Yang (US 20210330425, henceforth Yang), and Buonavoglia et al. (Buonavoglia, A.; Leone, P.; Solimando, A.G.; Fasano, R.; Malerba, E.; Prete, M.; Corrente, M.; Prati, C.; Vacca, A.; Racanelli, V. Antibiotics or No Antibiotics, That Is the Question: An Update on Efficient and Effective Use of Antibiotics in Dental Practice. Antibiotics 2021, 10, 550., henceforth Buonavoglia) as applied to claim 9 above, and further in view of Balanger et al. (Balanger M, Hinet M, Vacher C, Bellaiche N, Charrier JL, Millot S. Osteomyelitis of the Mandible after Dental Implants in an Immunocompetent Patient. Case Rep Dent. 2017;2017:9525893. doi: 10.1155/2017/9525893. Epub 2017 Apr 2. PMID: 28469945; PMCID: PMC5392388., henceforth Balanger).
Regarding claim 12, Bermudez-Bejarano as modified discloses the presence of osteomyelitis of the jaws (see the rejections of claim 9 above regarding De Ceulaer).
Bermudez-Bejarano as modified does not disclose that the osteomyelitis of the jaws is caused by a prior dental implant and the affected area includes a site of the prior dental implant. Balanger teaches that osteomyelitis was known to be caused by dental implants (see pg. 2, left column, second paragraph and pg. 2, right column, second paragraph) and that such osteomyelitis results in an infected, necrotic affected area including the site of said dental implants (see pg. 1, left column, second paragraph, necrosis of tissues in osteomyelitis is known).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the osteomyelitis treatment method of Bermudez-Bejarano as modified to affected areas which were caused by prior dental implants as in Balanger, as these implant areas were known to cause osteomyelitis and as Balanger teaches that it is important to identify osteomyelitis especially when it is near a dental implant area such that the dental practitioner can accurately determine whether removal of the implant is necessary for successful treatment (Balanger pg. 1, right column, first paragraph).
Regarding claim 13, Bermudez-Bejarano as modified discloses the presence of osteomyelitis of the jaws (see the rejections of claim 9 above regarding De Ceulaer).
Bermudez-Bejarano as modified does not disclose that the osteomyelitis of the jaws is secondary osteomyelitis of the jaws. Balanger teaches that chronic osteomyelitis was known to be caused by dental implants (see pg. 2, left column, second paragraph and pg. 2, right column, second paragraph) and that such chronic osteomyelitis results in an infected, necrotic affected area including the site of said dental implants (see pg. 1, left column, second paragraph, necrosis of tissues in osteomyelitis is known). {Examiner notes that chronic osteomyelitis includes secondary osteomyelitis when there is an abscess during sequestration as indicated by Applicant’s specification in [0004], and there was an abscess as indicated in pg. 3, right column, first paragraph.}
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the osteomyelitis treatment method of Bermudez-Bejarano as modified to affected areas which were caused by prior dental implants as in Balanger, as these implant areas were known to cause chronic osteomyelitis and as Balanger teaches that it is important to identify chronic osteomyelitis especially when it is near a dental implant area such that the dental practitioner can accurately determine whether removal of the implant is necessary for successful treatment (Balanger pg. 1, right column, first paragraph).
Response to Arguments
Applicant's arguments filed 04/27/2026 have been fully considered but they are not persuasive.
Applicant first argues that the relied upon combination of references does not disclose the claimed limitations regarding the piezoelectric surgery, especially regarding vibrations in the claimed frequency ranges for removing necrotic bone and creation of bleeding spots. Examiner respectfully disagrees; as indicated above, Lynch and Buonavoglia teach the claimed surgical steps for treatment of osteomyelitis but do not teach specific vibration ranges; Briscoe teaches the claimed range to be known in the art for cutting of bone as required by the surgical steps of Lynch and Buonavoglia, and it would have been obvious to one of ordinary skill in the art to have used the vibration range of Briscoe for the surgical steps of Lynch and Buonavoglia as Briscoe teaches the claimed range to be known in the art as leaving soft tissues undamaged but providing for bone cutting as required (see Briscoe [0003], [0004], and [0026]). Regarding Applicant’s argument that Briscoe describes cutting soft tissue, Briscoe [0004] teaches “The latter advantage relies on the fact that the ultrasound frequencies useful to drill bone tissues (20-30 kHz) are ineffective to for soft tissues, the cutting of which requires higher frequencies (50-60 kHz). Accordingly, by setting the frequency to the range wherein bone is impacted but soft tissues are not, it is possible to impact bone selectively”, and thus this is found unpersuasive.
Applicant additionally argues that the combination of references does not disclose the required antibiotic treatment limitations as the relied upon Bermudez-Bejarano references teaches pre-treatment with one antibiotic and post treatment with a separate, second antibiotic; the claims do not require the antibiotics to be administered simultaneously, only that there are two different antibiotics administered as treatment over the claimed time frame, and thus this argument is similarly found unpersuasive.
Thus, Applicant’s arguments are respectfully found unpersuasive and Examiner rejects the claims as indicated above.
Conclusion
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/SAMUEL J MARRISON/Examiner, Art Unit 3783
/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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