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 .
Response to Amendment
Applicant has amended claims 1, 9, and 14. Claims 1, 3-4, and 7-15 remain pending.
Applicant has also removed the recitation to inserts in the claims that previously caused an objection to the Drawings; Examiner accordingly withdraws the Drawings objection and notes that no Drawings are filed.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14 and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 14, the claim is indefinite where it now refers to independent claim 1; it is unclear which portions of claim 1 are meant to be required in claim 14 and which are not in the amended claim. This is further rendered unclear where none of the claim elements or limitations in claim 14 rely on antecedent basis from claim 1, as claim 14 appears to introduce all new limitations, and thus it is unclear which surgical or medicine treatment steps are meant to be repeated or only required a single time. For the purposes of compact prosecution, Examiner has understood claim 14 to be independent from claim 1, but since it shares claim limitations with claim 1, Examiner has cited the rejection of claim 1 based on prior art references for the rejection of claim 14 based on prior art. Prior art for the steps which Applicant intends to be required from claim 1 which are meant to be recited in claim 14 can thus be found in the rejection of claim 1.
Claim 15 is indefinite due to its dependency on, and thus requirement of the indefinite limitations of, independent claim 14.
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), comprising: 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”) 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).
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 this Office Action.}
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 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) comprising 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), comprising: 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”) 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).
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 this Office Action.}
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 , 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) comprising 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).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over 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), and 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) 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).
Regarding claim 14, Bermudez-Bejarano as modified discloses the method of treating osteomyelitis of jaws, comprising: administering piezoelectric surgery to remove necrotic bone and create bleeding spots in an affected area of a patient's jaw as recited in claim 1; and administering an antibiotic treatment to the patient for one week prior to the piezoelectric bone surgery and two weeks after the piezoelectric surgery, the antibiotic treatment including administering a first antibiotic targeting β-lactam and broad spectrum bacteria twice daily and a second antibiotic targeting anaerobic bacteria three times a day (see rejection of claim 1 above which explains the rejection of these claim elements).
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 15, Bermudez-Bejarano as modified discloses the method wherein the osteomyelitis of the jaws is secondary osteomyelitis of the jaws (see Balanger pg. 2, right column, second paragraph, the osteomyelitis is chronic osteomyelitis, and chronic osteomyelitis includes secondary osteomyelitis). {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.}
Response to Arguments
Applicant's arguments filed 11/20/2025 have been fully considered but they are not persuasive.
Applicant has argued that the combination of references fails to teach or suggest the method in the claims directed to treatment of osteomyelitis using piezoelectric surgery, and particularly that Briscoe does not teach or suggest such treatment of osteomyelitis using piezoelectric surgery. Examiner respectfully disagrees. Briscoe teaches the use of piezoelectric surgery in dental orthopedic procedures including piezoelectric devices operating at the claimed frequencies, and Lynch teaches the use of dental orthopedic surgery including administering surgery to remove necrotic bone (see Lynch [0006] and [0144]) and create bleeding spots in an affected area of target tissue (see Lynch [0144], intramarrow bone penetrations are performed to produce bleeding bone). Thus, in the modified method, it is the Examiner’s position that one of ordinary skill in the art would have combined the teachings of the prior art to have applied the mode of surgery of Briscoe (piezoelectric surgery in the claimed frequency range) as the type of orthopedic surgery which is used in Lynch (removing necrotized bone and creating bleeding spots) for the treatment of osteonecrosis and osteomyelitis, especially because Briscoe teaches that piezoelectric devices are generally known for use in dentistry and are beneficial for providing “(a) greater precision; (b) reduction of heat produced during the cutting; (c) production of holes freer of bone debris; and (d) selective drilling of bone tissues” (see Briscoe [0003]).
Examiner also notes that the claim does not prevent the use of vibrations at frequencies or micro-vibration distances outside of the claimed ranges, but rather requires that the claimed frequencies and distances are used.
Thus, Applicant’s arguments are respectfully found unpersuasive and Examiner rejects the claims as indicated above.
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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Weeda (“Goodbye BRONJ… Hello MRONJ”, Taylor and Francis Group, 2016, previously made of record) is considered relevant prior art where it teaches that BRONJ and MRONJ are the same process which was renamed (see the final paragraph of the first column of pg. 283, “changing the name of the osteolytic process from BRONJ to MRONJ”).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783
/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783