+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 Objections
Claim 22 objected to because of the following informalities: the word fertilisation should be fertilization. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 1-5, 8-15, 18-19, 22, & 24 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.
Claim 1 recites the limitation "the cells" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "the sperm cells" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 5 & 15, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 10 recites the limitation "the cells" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the cells" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the cells" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the cells" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the motile animal cells" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation "the cells" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 22, it is unclear as to what is “for treating asthenozoospermia”, clarification is requested.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 1, 5, 8-10, 12, 15, 18, 19, 22, & 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0209717 hereinafter Bonutti.
In regard to Claim 1: Bonutti teaches of an apparatus for use in promoting motility of flagellar cells (Bonutti, Paragraph 134), comprising an acoustic energy emission module configured to generate ultrasound energy (Bonutti, Paragraph 49; Figure 1 Item 100), the module being configured to generate ultrasound waves within a frequency range of about 2 MHz and about 120 MHz (Bonutti, Paragraph 57); and an applicator module configured to direct the generated ultrasound waves to a locus of the cells (Bonutti, Paragraph 51; Figure 1 Item 104) for a duration of between about 5 seconds and about 35 seconds (Bonutti, Paragraph 75; “The transducer may be held in position or signals could be applied to a treatment site for a few milliseconds, few seconds, or a few minutes before moving the transducer to a new location or altering the signals for application at a different treatment site”).
Bonutti specifically fails to teach the module being configured to generate ultrasound waves within a frequency range of about 2 MHz and about 120 MHz (Bonutti, Paragraph 57; “In the exemplary embodiment, transducer 310 is configured to output ultrasound energy having a frequency selected to be above 20 kHz, such as from about 1 MHz to about 5 MHz”).
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to add the frequency of the ultrasound waves taught in Bonutti, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.II. The Examiner notes that a particular parameter must be recognized as a result effective variable, in this case, that parameter is frequency range in MHz which achieves the recognized result of transmitting ultrasonic vibratory energy to the treatment site therefore, one of ordinary skill in the art at the filing date of the invention would have found the claimed range through routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). See also In re Boesch, 617 F.2d 272, USPQ 215 (CCPA 1980). Examiner also notes the lack of criticality for the range of values given in the claim.
Bonutti also fails to teach for a duration of between about 5 seconds and about 35 seconds (Bonutti, Paragraph 75; “The transducer may be held in position or signals could be applied to a treatment site for a few milliseconds, few seconds, or a few minutes before moving the transducer to a new location or altering the signals for application at a different treatment site”).
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to add the duration of the applied treatment taught in Bonutti, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.II. The Examiner notes that a particular parameter must be recognized as a result effective variable, in this case, that parameter is time in seconds which achieves the recognized result of preventing from overstimulation of the user therefore, one of ordinary skill in the art at the filing date of the invention would have found the claimed range through routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). See also In re Boesch, 617 F.2d 272, USPQ 215 (CCPA 1980). Examiner also notes the lack of criticality for the range of values given in the claim.
In regard to Claim 5: Bonutti teaches of the apparatus of claim 1,wherein the acoustic energy emission module is configured to generate ultrasound waves within frequency range of about 5 MHz and about 100 MHz (Bonutti, Paragraph 57), more preferably of about 10 MHz and about 50 MHz, and yet more preferably of about 19.28 MHz.
Bonutti specifically fails to teach wherein the acoustic energy emission module is configured to generate ultrasound waves within frequency range of about 5 MHz and about 100 MHz (Bonutti, Paragraph 57; “In the exemplary embodiment, transducer 310 is configured to output ultrasound energy having a frequency selected to be above 20 kHz, such as from about 1 MHz to about 5 MHz”).
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to add the frequency of the ultrasound waves taught in Bonutti, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.II. The Examiner notes that a particular parameter must be recognized as a result effective variable, in this case, that parameter is frequency range in MHz which achieves the recognized result of transmitting ultrasonic vibratory energy to the treatment site therefore, one of ordinary skill in the art at the filing date of the invention would have found the claimed range through routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). See also In re Boesch, 617 F.2d 272, USPQ 215 (CCPA 1980). Examiner also notes the lack of criticality for the range of values given in the claim.
In regard to Claim 8: Bonutti teaches of the apparatus of claim 1, wherein the applicator module is configured to direct the generated ultrasound waves for a duration of between about 15 seconds and about 25 seconds (Bonutti, Paragraph 75; “The transducer may be held in position or signals could be applied to a treatment site for a few milliseconds, few seconds, or a few minutes before moving the transducer to a new location or altering the signals for application at a different treatment site”).
Bonutti also fails to teach wherein the applicator module is configured to direct the generated ultrasound waves for a duration of between about 15 seconds and about 25 seconds (Bonutti, Paragraph 75; “The transducer may be held in position or signals could be applied to a treatment site for a few milliseconds, few seconds, or a few minutes before moving the transducer to a new location or altering the signals for application at a different treatment site”).
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to add the duration of the applied treatment taught in Bonutti, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.II. The Examiner notes that a particular parameter must be recognized as a result effective variable, in this case, that parameter is time in seconds which achieves the recognized result of preventing from overstimulation of the user therefore, one of ordinary skill in the art at the filing date of the invention would have found the claimed range through routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). See also In re Boesch, 617 F.2d 272, USPQ 215 (CCPA 1980). Examiner also notes the lack of criticality for the range of values given in the claim.
In regard to Claim 9: Bonutti teaches of the apparatus of claim 8, wherein the applicator module is configured to direct the generated ultrasound waves for a duration of about 20 seconds (Bonutti, Paragraph 75; “The transducer may be held in position or signals could be applied to a treatment site for a few milliseconds, few seconds, or a few minutes before moving the transducer to a new location or altering the signals for application at a different treatment site”).
Bonutti also fails to teach wherein the applicator module is configured to direct the generated ultrasound waves for a duration of about 20 seconds (Bonutti, Paragraph 75; “The transducer may be held in position or signals could be applied to a treatment site for a few milliseconds, few seconds, or a few minutes before moving the transducer to a new location or altering the signals for application at a different treatment site”).
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to add the duration of the applied treatment taught in Bonutti, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.II. The Examiner notes that a particular parameter must be recognized as a result effective variable, in this case, that parameter is time in seconds which achieves the recognized result of preventing from overstimulation of the user therefore, one of ordinary skill in the art at the filing date of the invention would have found the claimed range through routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). See also In re Boesch, 617 F.2d 272, USPQ 215 (CCPA 1980). Examiner also notes the lack of criticality for the range of values given in the claim.
In regard to Claim 10: Bonutti teaches of a method for promoting motility of flagellar cells (Bonutti, Paragraph 134), comprising the steps of: generating ultrasound waves within a frequency range of about 2 MHz and about 120 MHz (Bonutti, Paragraph 57); and exposing a locus of the cells to the generated ultrasound waves for a duration of between about 5 seconds and about 35 seconds (Bonutti, Paragraph 75; “The transducer may be held in position or signals could be applied to a treatment site for a few milliseconds, few seconds, or a few minutes before moving the transducer to a new location or altering the signals for application at a different treatment site”).
Bonutti specifically fails to teach the module being configured to generate ultrasound waves within a frequency range of about 2 MHz and about 120 MHz (Bonutti, Paragraph 57; “In the exemplary embodiment, transducer 310 is configured to output ultrasound energy having a frequency selected to be above 20 kHz, such as from about 1 MHz to about 5 MHz”).
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to add the frequency of the ultrasound waves taught in Bonutti, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.II. The Examiner notes that a particular parameter must be recognized as a result effective variable, in this case, that parameter is frequency range in MHz which achieves the recognized result of transmitting ultrasonic vibratory energy to the treatment site therefore, one of ordinary skill in the art at the filing date of the invention would have found the claimed range through routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). See also In re Boesch, 617 F.2d 272, USPQ 215 (CCPA 1980). Examiner also notes the lack of criticality for the range of values given in the claim.
Bonutti also fails to teach for a duration of between about 5 seconds and about 35 seconds (Bonutti, Paragraph 75; “The transducer may be held in position or signals could be applied to a treatment site for a few milliseconds, few seconds, or a few minutes before moving the transducer to a new location or altering the signals for application at a different treatment site”).
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to add the duration of the applied treatment taught in Bonutti, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.II. The Examiner notes that a particular parameter must be recognized as a result effective variable, in this case, that parameter is time in seconds which achieves the recognized result of preventing from overstimulation of the user therefore, one of ordinary skill in the art at the filing date of the invention would have found the claimed range through routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). See also In re Boesch, 617 F.2d 272, USPQ 215 (CCPA 1980). Examiner also notes the lack of criticality for the range of values given in the claim.
In regard to Claim 12: Bonutti teaches of the method of claim 10, wherein the locus of the cells is exposed to the generated ultrasound waves via an applicator module (Bonutti, Paragraphs 105 & 107; “Device 100 may include one or more modalities for improving fluid flow of medicinal agents [e.g., pharmaceuticals, biologics, enzymes, etc.] into cells”).
In regard to Claim 15: Bonutti teaches of the method of claim 10, comprising generating ultrasound waves within a frequency range of about 5 MHz and about 100 MHz (Bonutti, Paragraph 57), more preferably of about 10 MHz and about 50 MHz, and yet more preferably of about 19.28 MHz.
Bonutti specifically fails to teach wherein the acoustic energy emission module is configured to generate ultrasound waves within frequency range of about 5 MHz and about 100 MHz (Bonutti, Paragraph 57; “In the exemplary embodiment, transducer 310 is configured to output ultrasound energy having a frequency selected to be above 20 kHz, such as from about 1 MHz to about 5 MHz”).
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to add the frequency of the ultrasound waves taught in Bonutti, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.II. The Examiner notes that a particular parameter must be recognized as a result effective variable, in this case, that parameter is frequency range in MHz which achieves the recognized result of transmitting ultrasonic vibratory energy to the treatment site therefore, one of ordinary skill in the art at the filing date of the invention would have found the claimed range through routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). See also In re Boesch, 617 F.2d 272, USPQ 215 (CCPA 1980). Examiner also notes the lack of criticality for the range of values given in the claim.
In regard to Claim 18: Bonutti teaches of the method of claim 10, comprising exposing the cells to the generated ultrasound waves for a duration of between about 15 seconds and about 25 seconds (Bonutti, Paragraph 75; “The transducer may be held in position or signals could be applied to a treatment site for a few milliseconds, few seconds, or a few minutes before moving the transducer to a new location or altering the signals for application at a different treatment site”).
Bonutti also fails to teach comprising exposing the cells to the generated ultrasound waves for a duration of between about 15 seconds and about 25 seconds (Bonutti, Paragraph 75; “The transducer may be held in position or signals could be applied to a treatment site for a few milliseconds, few seconds, or a few minutes before moving the transducer to a new location or altering the signals for application at a different treatment site”).
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to add the duration of the applied treatment taught in Bonutti, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.II. The Examiner notes that a particular parameter must be recognized as a result effective variable, in this case, that parameter is time in seconds which achieves the recognized result of preventing from overstimulation of the user therefore, one of ordinary skill in the art at the filing date of the invention would have found the claimed range through routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). See also In re Boesch, 617 F.2d 272, USPQ 215 (CCPA 1980). Examiner also notes the lack of criticality for the range of values given in the claim.
In regard to Claim 19: Bonutti teaches of the method of claim 10, comprising exposing the motile animal cells to the generated ultrasound waves for a duration of about 20 seconds (Bonutti, Paragraph 75; “The transducer may be held in position or signals could be applied to a treatment site for a few milliseconds, few seconds, or a few minutes before moving the transducer to a new location or altering the signals for application at a different treatment site”).
Bonutti also fails to teach comprising exposing the motile animal cells to the generated ultrasound waves for a duration of about 20 seconds (Bonutti, Paragraph 75; “The transducer may be held in position or signals could be applied to a treatment site for a few milliseconds, few seconds, or a few minutes before moving the transducer to a new location or altering the signals for application at a different treatment site”).
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to add the duration of the applied treatment taught in Bonutti, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.II. The Examiner notes that a particular parameter must be recognized as a result effective variable, in this case, that parameter is time in seconds which achieves the recognized result of preventing from overstimulation of the user therefore, one of ordinary skill in the art at the filing date of the invention would have found the claimed range through routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). See also In re Boesch, 617 F.2d 272, USPQ 215 (CCPA 1980). Examiner also notes the lack of criticality for the range of values given in the claim.
In regard to Claim 22: Bonutti teaches of the method of claim 10, wherein the cells are sperm cells, for treating asthenozoospermia, for improving fertilisation potential of sperm cells or for determining sperm cell viability (Bonutti, Paragraph 134).
In regard to Claim 24: Bonutti teaches of the method of claim 10, wherein an acoustic energy emission module is provided to output ultrasound at a given frequency range (Bonutti, Paragraph 75), input power and for a particular duration based on cellular type (Bonutti, Paragraph 73).
Claim(s) 2 & 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0209717 hereinafter Bonutti in view of US 2003/0071540 hereinafter Ito.
In regards to Claim 2: Bonutti teaches of the apparatus of claim 1, but does not teach wherein the acoustic energy emission module comprises two sets of interdigitate transducers configured to generate ultrasound energy in the form of standing acoustic waves.
Ito teaches wherein the acoustic energy emission module comprises two sets of interdigitate transducers configured to generate ultrasound energy in the form of standing acoustic waves (Ito, Paragraph 5; Figure 1 Item 2 & 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the transducers taught in Ito to the device of Bonutti, the motivation being to provide an uniform electrical field over the target area.
In regard to Claim 11: Bonutti teaches of the method claim 10, but does not teach wherein the ultrasound waves are generated in the form of standing acoustic waves by an acoustic energy emission module comprising two sets of interdigitate transducers.
Ito teaches wherein the ultrasound waves are generated in the form of standing acoustic waves by an acoustic energy emission module comprising two sets of interdigitate transducers (Ito, Paragraph 5; Figure 1 Item 2 & 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the transducers taught in Ito to the device of Bonutti, the motivation being to provide an uniform electrical field over the target area.
Claim(s) 3 & 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0209717 hereinafter Bonutti in view of US 4,743,361 hereinafter Schram.
In regard to Claim 3: Bonutti teaches of the apparatus of claim 1, but does not teach wherein the applicator module comprises a polydimethylsiloxane fluid chamber or a fluid chamber attached with acoustic coupling medium to house the sperm cells.
Schram teaches wherein the applicator module comprises a polydimethylsiloxane fluid chamber or a fluid chamber attached with acoustic coupling medium to house the sperm cells (Schram, Column 18 Lines 1-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the fluid chamber attached with acoustic coupling taught by Schram to the method taught in Bonutti, the motivation being to maximize acoustic transmissions into the user.
In regard to Claim 4: Bonutti teaches of the method of claim 10, but does not teach wherein the applicator module comprises a polydimethylsiloxane fluid chamber or a fluid chamber attached with acoustic coupling medium to house the sperm cells.
Schram teaches wherein the applicator module comprises a polydimethylsiloxane fluid chamber or a fluid chamber attached with acoustic coupling medium to house the sperm cells (Schram, Column 18 Lines 1-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the fluid chamber attached with acoustic coupling taught by Schram to the method taught in Bonutti, the motivation being to maximize acoustic transmissions into the user.
Claim(s) 4 & 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0209717 hereinafter Bonutti in view of US 4,743,361 hereinafter Schram in view of 2020/0346044 hereinafter Woodacre.
In regard to Claim 4: A modified Bonutti teaches of the apparatus of claim 3, but does not teach wherein the fluid chamber attached with acoustic coupling medium is a glass fluid chamber.
Woodacre teaches wherein the fluid chamber attached with acoustic coupling medium is a glass fluid chamber (Woodacre, Paragraph 77; Examiner points out that prior art exemplifies that glass has acoustic impedance matching propertied, assisting in the transfer of sound needed in the current device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the acoustic impedance matching properties provided by glass to the fluid chamber of taught in a modified Bonutti, the motivation being to provide a material with acoustic impedance matching properties.
In regard to Claim 14: A modified Bonutti teaches of the apparatus of claim 13, but does not teach wherein the fluid chamber attached with acoustic coupling medium is a glass fluid chamber.
Woodacre teaches wherein the fluid chamber attached with acoustic coupling medium is a glass fluid chamber (Woodacre, Paragraph 77; Examiner points out that prior art exemplifies that glass has acoustic impedance matching propertied, assisting in the transfer of sound needed in the current device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the acoustic impedance matching properties provided by glass to the fluid chamber of taught in a modified Bonutti, the motivation being to provide a material with acoustic impedance matching properties.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOE R DIETZ whose telephone number is (571)272-1135. The examiner can normally be reached Mon-Fri 8am - 5pm.
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/N.R.D./Patent Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
