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 .
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schultheiss et al. (US 2006/0036194 A1).
Regarding claim 1, Schultheiss discloses a method of treatment for a sensitive gum tissue exhibiting a sensitivity to touch, heat or cold conditions in a diagnosed patient (“method of treatment for a periodontal tissue exhibiting a periodontal disease or periodontal conditions in a diagnosed patient”, periodontal diseases and/or conditions may lead to sensitivity of the gums, Abstract) comprises the steps of activating an acoustic shock wave generator or source to emit acoustic shock waves (“method has the steps of activating an acoustic shock wave generator or source to emit acoustic shock waves”, Abstract and Figure 14); and subjecting the sensitive gum tissue of the patient to the acoustic shock waves stimulating said gum tissue (“subjecting the periodontal tissue of the patient to the acoustic shock waves stimulating said tissue”, Abstract), wherein the gum tissue is positioned within a path of the emitted shock waves (“wherein the tissue is positioned within a path of the emitted shock waves”, Abstract).
Regarding claim 2, Schultheiss further discloses the emitted shock waves are convergent, divergent, planar or near planar (“emitted shock waves are convergent, divergent, planar or near planar”, Paragraph 0014).
Regarding claim 3, Schultheiss further discloses wherein the emitted shock waves are convergent having one or more geometric focal volumes of points at a distance of at least X from the generator or source, the method further comprising positioning the gum tissue at a distance at or less than the distance X from the source (“the emitted shock waves can be convergent having one or more geometric focal volumes or points at a distance of at least X from the generator or source, the method further comprising positioning the organ at a distance at or less than the distance X from the source”, Paragraph 0014).
Regarding claim 4, Schultheiss further discloses further comprises the step of administering one or more medicaments prior, during or after subjecting the patient to acoustic shock waves (“the method of treatment may further have the steps of administering one or more medicaments prior, during or after subjecting the patient to acoustic shock waves”, Paragraph 0015).
Regarding claim 5, Schultheiss further discloses testing the sensitivity of the treated gum tissue of the diagnosed patient before and after exposure to one or more acoustic shock wave treatments (testing the bacterial count or viability of the treated tissue or region of the diagnosed patient after exposure to one or more acoustic shock wave treatments, Paragraph 0015).
Regarding claim 6, Schultheiss further discloses further comprises the step of: numbing and desensitizing the gum tissue (in some cases the gums may require numbing prior to treatment, Paragraph 0074).
Regarding claim 7, Schultheiss further discloses wherein the treated gum tissue has no indication of periodontal disease including any indication of one or more pathological conditions including: a periodontal biofilm mass, periapical endodontic lesions, endo-perio lesions, gingivitis, inflammation of gingival tissue, periodontitis, progressive loss of ligament, cementum or alveolar bone support to teeth (the Examiner notes this limitation is directed towards an intended use limitation that does not add any structural or manipulative limitations and therefore does not carry any patentable weight (i.e. the treated gum tissue having no indication of periodontal disease does not add any further limitations on the method of treatment). As Schultheiss’s method of treating gum tissue would treat gum tissue regardless of whether or not the tissue comprises indication of a pathological condition, and Paragraph 0065 of Schultheiss states “or preventing such conditions from occurring”, the Examiner considers this limitation to be disclosed by the prior art)).
Regarding claim 8, Schultheiss further discloses wherein the treated gum tissue activates or otherwise stimulates stem cells or release of cellular growth factors in the oral structure effecting a tissue repair or tissue regeneration (providing a stimulating stem cell activation or a cellular release or activation of VEGF and other growth factors, Paragraph 0077).
Regarding claim 9, Schultheiss discloses a method of treating a patient exhibiting sensitivity of gum tissue to reduce pain and inflammation using pressure pulses or shock waves (“method of treatment for a periodontal tissue exhibiting a periodontal disease or periodontal conditions in a diagnosed patient”, Abstract; various therapeutic pressure pulse wave patterns or acoustic shock waves are used to treat periodontal conditions, Paragraph 0056 and Figures 1-12) comprises the steps of: placing an applicator head of an acoustic shock wave or pressure pulse generator or source near the gum tissue of the patient (see shock wave generator comprises a shock wave head 43 placed near the gum tissue of the patient, Paragraph 0075 and Figure 14); coupling the applicator head directly or indirectly to an exposed surface of the skin near the gum tissue (shock wave head 43 may be placed either directly on treatment region such as the gums or placed on the check tissue and into the adjacent gingival tissue 100 to be treated, Paragraph 0074 and Figure 14); and activating the generator or source to emit pressure pulses or acoustic shock waves to the gum tissue exhibiting pain and inflammation to reduce the pain and inflammation (activating an acoustic shock wave generator or source to emit acoustic shock waves; and subjecting the periodontal tissue, or the entire periodontal region of the patient to the acoustic shock waves stimulating said tissue, Abstract).
Regarding claim 10, Schultheiss further discloses wherein the emitted pressure pulses or acoustic shock waves are transmitted in a pattern passing through the gum tissue (emitted shock wave patterns pass through the check tissue and into gum tissue, Paragraph 0074).
Regarding claim 11, Schultheiss further discloses wherein the emitted pressure pulses or acoustic shock waves pattern impinges the gum tissue (the emitted shock wave patterns impinge the affected organ or tissue, Paragraph 0077).
Regarding claim 12, Schultheiss further discloses wherein the pressure pulse being an acoustic pulse which includes several cycles of positive and negative pressure (pressure pulses being an acoustic pulse which includes several cycles of positive and negative pressures, Paragraph 0040).
Regarding claim 13, Schultheiss further discloses wherein the pressure pulse has an amplitude of the positive part of such a cycle should be above 0.1 MPa and the time duration of the pressure pulse is from below a microsecond to about a second (The amplitude of the positive part of such a cycle should be above about 0.1 MPa and its time duration is from below a microsecond to about a second, Paragraph 0040).
Regarding claim 14, Schultheiss further discloses wherein the rise times of the positive part of the first pressure cycle is in the range of nanoseconds (ns) up to some milliseconds (ms) (rise times of the positive part of the first pressure cycle may be in the range of nano-seconds (ns) up to some milli-seconds (ms), Paragraph 0040)).
Regarding claim 15, Schultheiss further discloses wherein the acoustic shock waves being very fast pressure pulses having amplitudes above 0.1 MPa and rise times of the amplitude being below 1000 ns (very fast pressure pulses are called shock waves. Shock waves used in medical applications do have amplitudes above 0.1 MPa and rise times of the amplitude are below 1000 ns, Paragraph 0040).
Regarding claim 16, Schultheiss further discloses wherein the duration of the shock wave is typically below 1-3 microseconds (ps) for the positive part of a cycle and typically above some microseconds for the negative part of a cycle (The duration of a shock wave is typically below 1-3 micro-seconds (.mu.s) for the positive part of a cycle and typically above some micro-seconds for the negative part of a cycle, Paragraph 0040).
Regarding claim 17, Schultheiss further discloses wherein subjecting the gum tissue to convergent, divergent, planar or near planar acoustic shock waves or pressure pulses (“emitted shock waves are convergent, divergent, planar or near planar”, Paragraph 0014). in the absence of a focal point impinging the cells stimulating a cellular response in the absence of creating cavitation bubbles evidenced by not experiencing the sensation of hemorrhaging caused by the emitted waves or pulses in cells wherein the cells are positioned within a path of the emitted shock waves or pressure pulses (the Examiner notes this limitation is directed towards an intended use limitation that does not add any structural or manipulative limitations and therefore does not carry any patentable weight (i.e. the treated gum tissue having a cellular response in absence of creating cavitation bubbles evidenced by not experiencing the sensation of hemorrhaging caused by the emitted waves). As Schultheiss’s method of treating gum tissue would treat gum tissue in the same manner in which the Applicant claims, the Examiner considers this limitation to be disclosed by the prior art)) and away from any localized geometric focal volume or point of the emitted shock waves wherein the emitted shock waves or pressure pulses either have no geometric focal volume or point or have a focal volume or point ahead of the cells or beyond the cells thereby passing the emitted waves or pulses through the cells while avoiding having any localized focal point within the cells (the shock wave 200 extends to a focal point or focal geometric volume 20 at a location spaced a distance X from the generator or source 1, Paragraph 0122 and Figures 10-12).
Regarding claim 18, Schultheiss further discloses wherein the emitted pressure pulses or shock waves are convergent, divergent, planar or near planar (“emitted shock waves are convergent, divergent, planar or near planar”, Paragraph 0014) and the pressure pulse shock wave generator or source is based on electro-hydraulic, electromagnetic, piezoceramic or ballistic wave generation having an energy density value ranging as low as 0.00001 mJ/mm2 to a high end of below 1.0 mJ/mm2 (The unfocused waves can be divergent, planar or near planar and having a low pressure amplitude and density in the range of 0.00001 mJ/mm.sup.2 to 1.0 mJ/mm.sup.2 or less, Paragraph 0074; electro-hydraulic pressure pulse/wave generator, Paragraph 0049 and Figure 3).
Regarding claim 19, Schultheiss further discloses wherein subjecting the gum tissue directly to the acoustic shock waves having a low energy density of less than 1.0 mJ/mm2 per shock wave (the unfocused waves can be divergent, planar or near planar and having a low pressure amplitude and density in the range of 0.00001 mJ/mm.sup.2 to 1.0 mJ/mm.sup.2 or less, Paragraph 0074, Paragraph 0074) stimulates said cells or gum tissue wherein the cells or gum tissue is positioned directly within a path of the emitted pressure pulses (deploying shock waves to stimulate strong cells in the surrounding tissue to activate, Paragraph 0079, Figure 14) or acoustic shock waves in the absence of any focal point or if a focal point exists, the cells or gum tissue being treated is positioned away from any focal point (the shock wave 200 extends to a focal point or focal geometric volume 20 at a location spaced a distance X from the generator or source 1, Paragraph 0122 and Figures 10-12).
Regarding claim 20, Schultheiss further discloses wherein the energy density is selected to avoid any cell damage to the cells or gum tissue (selected treatment dosage is avoidance or minimization of surrounding cell damage, Paragraph 0077),
Regarding claim 21, Schultheiss further discloses wherein treating the gum tissue to stimulate by accelerating or increasing cell growth or regeneration (the stimulation of growth factors promote accelerated healing, Paragraph 0096) wherein the administering is applied to the patient who has a pathological condition of the gums exhibiting damage caused by gum disease, injury or inflammation, any one of which has caused pain and inflammation (treated periodontal tissue may include a pathological condition caused by gum disease, injury or inflammation, Paragraph 0015) which is reduced by the treatment (treatment reduced noticeable pain, Paragraph 0086).
Regarding claim 22, Schultheiss further discloses stimulates by accelerating and increasing cell tissue growth or regeneration or repair in addition to reducing gum tissue swelling and pressure and inflammation (the stimulation of growth factors promote accelerated healing, Paragraph 0096) in the absence of any pathological condition (the Examiner notes this limitation is directed towards an intended use limitation that does not add any structural or manipulative limitations and therefore does not carry any patentable weight (i.e. the treated gum tissue having no indication of a pathological disease does not add any further limitations on the method of treatment). As Schultheiss’s method of treating gum tissue would treat gum tissue regardless of whether or not the tissue comprises indication of a pathological condition, the Examiner considers this limitation to be disclosed by the prior art)) and wherein the cell or gum tissue is from a mammal which is a human or an animal (human or mammal periodontal tissue, Paragraph 0074).
Regarding claim 23, Schultheiss discloses a method of treating a patient exhibiting sensitivity of gum tissue to reduce pain and inflammation using pressure pulses or shock waves (“method of treatment for a periodontal tissue exhibiting a periodontal disease or periodontal conditions in a diagnosed patient”, periodontal diseases and/or conditions may lead to sensitivity of the gums, Abstract) comprises the steps of placing an applicator head of an acoustic shock wave or pressure pulse generator or source near the cheek of the patient (see shock wave generator comprises a shock wave head 43 placed near the cheek of the patient, Paragraph 0075 and Figure 14); coupling the applicator head directly or indirectly to an exposed surface of the skin near the cheek (shock wave head 43 may be placed either directly on treatment region such as the gums or placed on the check tissue and into the adjacent gingival tissue 100 to be treated, Paragraph 0074 and Figure 14); and activating the generator or source to emit pressure pulses or acoustic shock waves to the gum tissue exhibiting pain and inflammation to reduce the pain and inflammation (activating an acoustic shock wave generator or source to emit acoustic shock waves; and subjecting the periodontal tissue, or the entire periodontal region of the patient to the acoustic shock waves stimulating said tissue, Abstract).
Regarding claim 24, Schultheiss discloses a method of treating a patient exhibiting sensitivity of gum tissue using a reflexology zone to reduce pressure and inflammation causing proptosis (“method of treatment for a periodontal tissue exhibiting a periodontal disease or periodontal conditions in a diagnosed patient”, periodontal diseases and/or conditions may lead to sensitivity of the gums, Abstract) using pressure pulses or shock waves (emitted shock wave patterns pass through the check tissue and into gum tissue, Paragraph 0074) comprises the steps of placing an applicator head of an acoustic shock wave or pressure pulse generator or source near a gum or mouth reflexology zone of the patient (see shock wave generator comprises a shock wave head 43 placed near a patient’s gum or mouth reflexology zone, Paragraph 0075 and Figure 14): coupling the applicator head directly or indirectly to an exposed surface of the skin near the gum or mouth reflexology zone (shock wave head 43 may be placed either directly on treatment region such as the gums or placed on the check tissue and into the adjacent gingival tissue 100 to be treated, Paragraph 0074 and Figure 14): and activating the generator or source to emit pressure pulses or acoustic shock waves to the gum or mouth reflexology zone to treat the gum tissue exhibiting pain and inflammation to reduce the pain and inflammation (activating an acoustic shock wave generator or source to emit acoustic shock waves; and subjecting the periodontal tissue, or the entire periodontal region of the patient to the acoustic shock waves stimulating said tissue, Abstract).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Spector (US 6,755,796 B2) and Voss et al. (US 5,595,178).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH B LEDERER whose telephone number is 571-272-7274. The examiner can normally be reached on Monday - Friday, 7:30 AM - 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached on (571)-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH B LEDERER/Examiner, Art Unit 3785
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785