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 § 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 1- 20 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.
The term “substantially” in claim 1 (line 7) is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Accordingly, the examiner cannot determine the metes and bounds of the presently claimed invention as defined by claim 1.
In order to provide an initial examination and search the examiner will interpret claim 1 as if the word “substantially” in line 7 were deleted or absent.
The 112 rejection an initial examiner interpretation/treatment immediately above applies to:
Claim 2 (line 4),
Claim 3 (line 5),
Claim 4 (line 2),
Claim 5 (line 8),
Claim 10 (line 4),
Claim 14 (line 4),
Claim 15 (line 5), and
Claim 17 (line 6).
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.
Claims 1-5, and 9-16 are rejected under 35 U.S.C. 103 as being unpatentable over Dahl et al. (U.S. Patent Application Publication 2017/0080237) in view of Laghi (U.S. Patent Application Publication 2006/0111485).
Regarding claims 1 and 9, Dahl et al. disclose a method of making an implantable medical device, the method comprising:
heating a filler material to a liquid, flowable state (“liquid composition 152,” see [0027], [0040], figure 3, and claim 2 for example),
depositing the filler material in the liquid, flowable state into a cavity to encapsulate the electrical components within the filler material (see [0005], [0022], [0027]-[0028] and figure 3), and
allowing the gel filler material to cool to a semi-solid state (see [0040], and claims 1-2 for example.).
Dahl et al. fail to recite the filler material is a gel filler material comprising a styrene-ethylene-butylene-styrene (SEBS) thermoplastic block copolymer and a plasticizing oil – in the form of mineral oil {claim 9}.
Like Dahl et al., Laghi discloses an implantable medical device using a liquid filler material that solidifies upon cooling and teach the liquid filler material is a gel filler material comprising a styrene-ethylene-butylene-styrene (SEBS) thermoplastic block copolymer (see [0041]) and a plasticizing oil (see [0042]) in order to provide a known and workable example of a gel filler material for an implantable medical device.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Dahl et al., as taught by Laghi, to make the liquid filler material from a gel filler material comprising a styrene-ethylene-butylene-styrene (SEBS) thermoplastic block copolymer and a plasticizing oil in order to provide a known and workable example of a gel filler material for an implantable medical device.
Regarding claims 2-3, Dahl et al. disclose the claimed invention including a housing (“housing 102 can include a housing wall 150,” see [0026] and figure 3) wherein A) the housing comprises a first housing part (the upper portion of 102 in figure 3) and the cavity comprises a first cavity portion (the cavity adjacent upper portion of the circuit board 154 in figure 3) defined by the first housing part, and wherein a first set of the electrical components (“electronic components 156, 158, 160, 162,” see [0026] and figure 3) is disposed within the first cavity portion, and wherein depositing the gel
filler material includes depositing the gel filler material in the first cavity portion to
encapsulate the first set of the electrical components, and B) the housing comprises a second housing part (the lower portion of 102 in figure 3) and the cavity comprises a second cavity portion (the cavity at or below the upper portion of the circuit board 154 in figure 3) defined by the second housing part, and wherein a second set of the electrical components (“electronic components” 164, 166, 168, see [0026] and figure 3) is disposed within the second cavity portion, and wherein depositing the gel filler material includes depositing the gel filler material in the second cavity portion to encapsulate the second set of the electrical components.
Regarding claim 4, Dahl et al. disclose the claimed invention including comprising joining the first and second housing parts after allowing the gel filler material to cool to the semi-solid state ([0042]).
Regarding claim 5, Dahl et al. disclose the claimed invention including prior to
depositing the liquid filler material, forming the housing by joining first and second housing parts to define the cavity with the electrical components disposed therein, wherein the housing includes a fill port and an exhaust port; and wherein depositing the gel filler material includes introducing the gel filler material into the cavity through the fill port (see the apertures/holes in [0042]-[0044], [0046]); and
hermetically sealing the fill port and the exhaust port after allowing the filler material to cool to the solid state (see abstract, [0005], [0029], and [0042] for example).
Regarding claims 10-13, Dahl et al. disclose a device comprising:
a housing (“housing 102 can include a housing wall 150,” see [0026] and figure 3) defining a hermetically sealed cavity (see abstract, [0005], [0029], and [0042] for example);
electrical components (“electronic components 156, 158, 160, 162, 164, 166, 168,” see [0026] and figure 3) mounted within the housing; and
a semi-solid filler material (“liquid composition 152” that solidifies upon cooling, see [0027], [0040] and figure 3) disposed within the cavity and encapsulating the electrical components.
Dahl et al. fail to recite the filler material is a gel filler material comprising a styrene-ethylene-butylene-styrene (SEBS) {claim 11}, thermoplastic block copolymer {claim 10}, and a plasticizing oil {claim 12} – in the form of mineral oil {claim 13}.
Like Dahl et al., Laghi discloses an implantable medical device using a liquid filler material that solidifies upon cooling and teach the liquid filler material is a gel filler material comprising a styrene-ethylene-butylene-styrene (SEBS) thermoplastic block copolymer (see [0041]) and a plasticizing oil (see [0042]) in order to provide a known and workable example of a gel filler material for an implantable medical device.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Dahl et al., as taught by Laghi, to make the liquid filler material from a gel filler material comprising a styrene-ethylene-butylene-styrene (SEBS) thermoplastic block copolymer and a plasticizing oil in order to provide a known and workable example of a gel filler material for an implantable medical device.
Regarding claims 14-16, Dahl et al. disclose the claimed invention including a housing (“housing 102 can include a housing wall 150,” see [0026] and figure 3) wherein A) the housing comprises a first housing part (the upper portion of 102 in figure 3) and the cavity comprises a first cavity portion (the cavity adjacent upper portion of the circuit board 154 in figure 3) defined by the first housing part, and wherein a first set of the electrical components (“electronic components 156, 158, 160, 162,” see [0026] and figure 3) is disposed within the first cavity portion, and wherein depositing the gel
filler material includes depositing the gel filler material in the first cavity portion to
encapsulate the first set of the electrical components, and B) the housing comprises a second housing part (the lower portion of 102 in figure 3) and the cavity comprises a second cavity portion (the cavity at or below the upper portion of the circuit board 154 in figure 3) defined by the second housing part, and wherein a second set of the electrical components (“electronic components” 164, 166, 168, see [0026] and figure 3) is disposed within the second cavity portion, and wherein depositing the gel filler material includes depositing the gel filler material in the second cavity portion to encapsulate the second set of the electrical components.
With respect to claim 16, that is wherein the first housing part and the second housing part are joined to form the housing, see [0042] and figure 3.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Dahl et al. (U.S. Patent Application Publication 2017/0080237) in view of Laghi (U.S. Patent Application Publication 2006/0111485) as applied to claim 1 above, and further in view of case law.
Regarding claims 6, and 7, Dahl et al. in view of Laghi show the invention above
but fail to explicitly recite:
heating the gel filler material includes heating the gel filler material to a temperature above 70º C, and
allowing the gel filler material to cool includes allowing the gel filler to cool to a temperature below 70º C.
These two recitations are met if the combination makes obvious a gel filler material has a glass transition temperature of 70º C.
As can be seen by reviewing Dahl et al., Dahl et al. disclose a filler material that is in liquid form at temperatures between “about −50 degrees Celsius and 150 degrees Celsius,” see [0039], which means the glass transition temperature ranges from about just above −50 degrees Celsius to just above 150 degrees Celsius.
So having a glass transition temperature of 70º C for the filler material would fall within this disclosed range.
Therefore the examiner takes Official Notice of the claimed heating to above 70º C and cooling to below 70º C since 70º C is within the recited range given by Dahl et al., Dahl et al. disclose heating and cooling the filler material in order to manipulate whether the filler material is in the liquid state or solid state, and having the glass transition temperature at 70º C would avoid changing the state of the filler material by introducing into the body of the patient when it is implanted in the body of the patient thus keeping the device stable while it is in the patient’s body.
If applicant does not traverse the examiner’s assertion of official notice or applicant’s traverse is not adequate, the examiner should clearly indicate in the next Office action that the common knowledge or well-known in the art statement is taken to be admitted prior art because applicant either failed to traverse the examiner’s assertion of official notice or that the traverse was inadequate. If the traverse was inadequate, the examiner should include an explanation as to why it was inadequate,” see MPEP 2144.03C.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Dahl et al. in view of Laghi, as taught by Official Notice, to provide the (gel) filler material with a glass transition temperature of 70º C since 70º C is within the recited range given by Dahl et al., Dahl et al. disclose heating and cooling the filler material in order to manipulate whether the filler material is in the liquid state or solid state, and having the glass transition temperature at 70º C would avoid changing the state of the filler material by introducing into the body of the patient when it is implanted in the body of the patient thus keeping the device stable while it is in the patient’s body.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Dahl et al. (U.S. Patent Application Publication 2017/0080237) in view of Laghi (U.S. Patent Application Publication 2006/0111485) in view of case law (Official Notice) as applied to claim 6 above, and further in view of case law (Official Notice).
Regarding claim 8, Dahl et al. in view of Laghi ) in view of case law (Official Notice)) show the invention above
but fail to explicitly recite allowing the gel filler material to cool includes actively cooling the gel filler material in an environment below ambient temperature.
However, the examiner takes Official Notice of the step of allowing the gel filler material to cool includes actively cooling the gel filler material in an environment below ambient temperature since it is well known that liquid-to-solid transition time can be reduced by exposing the (gel) filler material to colder than ambient temperature.
If applicant does not traverse the examiner’s assertion of official notice or applicant’s traverse is not adequate, the examiner should clearly indicate in the next Office action that the common knowledge or well-known in the art statement is taken to be admitted prior art because applicant either failed to traverse the examiner’s assertion of official notice or that the traverse was inadequate. If the traverse was inadequate, the examiner should include an explanation as to why it was inadequate,” see MPEP 2144.03C.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Dahl et al. in view of Laghi in view of Official Notice, as further taught by Official Notice, to expose the (gel) filler material to colder than ambient temperature in order to reduce the liquid-to-solid transition time of the gel filler material.
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Dahl et al. (U.S. Patent Application Publication 2017/0080237) in view of case law (Official Notice) in further view of Laghi (U.S. Patent Application Publication 2006/0111485).
Regarding claims 17-20, Dahl et al. disclose a device/system comprising:
a hermetically sealed (“see abstract, [0005], [0029], and [0042] for example) housing forming an internal cavity (“housing 102 can include a housing wall 150,” see [0026] and figure 3);
electrical components mounted (“electronic components 156, 158, 160, 162, 164, 166, 168, 170,” see [0026] and figure 3) within the cavity of the housing, wherein portions of the cavity not occupied by the electrical components define a residual volume of the housing; and
a semi-solid filler material (“liquid composition 152,” see [0027], and [0040] for example) filling the residual volume and encapsulating the electrical components, the filler material assuming a flowable liquid state at a particular temperature or greater, and capable of transitioning to semi-solid state at a temperature below that particular temperature (see [0027], [0040], and claim 1 for example).
Dahl et al. fails to recite the filler material:
1) is a gel filler material assumes a flowable liquid state at a temperature of 70 degrees Celsius or greater, and capable of transitioning to semi-solid state at a temperature below 70 degrees Celsius {claim 17},
2) comprises a thermoplastic block copolymer and a plasticizing oil {claim 18}.
3) wherein the thermoplastic block copolymer is a styrene-ethylene-butylene-styrene (SEBS) thermoplastic block copolymer {claim 19}, and
4) wherein the plasticizing oil is a mineral oil {claim 20}.
With respect to the recitation that the filler material assumes a flowable liquid state at a temperature of 70 degrees Celsius or greater, and capable of transitioning to semi-solid state at a temperature below 70 degrees Celsius, the examiner interprets this as equivalent to the filler material has a glass transition temperature of 70º C.
As can be seen by reviewing Dahl et al., Dahl et al. disclose a filler material that is in liquid form at temperatures between “about −50 degrees Celsius and 150 degrees Celsius,” see [0039], which means the glass transition temperature ranges from about just above −50 degrees Celsius to just above 150 degrees Celsius.
So having a glass transition temperature of 70º C for the filler material would fall within this disclosed range.
Therefore the examiner takes Official Notice of the claimed heating to above 70º C and cooling to below 70º C since 70º C is within the recited range given by Dahl et al., Dahl et al. disclose heating and cooling the filler material in order to manipulate whether the filler material is in the liquid state or solid state, and having the glass transition temperature at 70º C would avoid changing the state of the filler material by introducing into the body of the patient when it is implanted in the body of the patient thus keeping the device stable while it is in the patient’s body.
If applicant does not traverse the examiner’s assertion of official notice or applicant’s traverse is not adequate, the examiner should clearly indicate in the next Office action that the common knowledge or well-known in the art statement is taken to be admitted prior art because applicant either failed to traverse the examiner’s assertion of official notice or that the traverse was inadequate. If the traverse was inadequate, the examiner should include an explanation as to why it was inadequate,” see MPEP 2144.03C.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Dahl et al., as taught by Official Notice, to provide the (gel) filler material with a glass transition temperature of 70º C since 70º C is within the recited range given by Dahl et al., Dahl et al. disclose heating and cooling the filler material in order to manipulate whether the filler material is in the liquid state or solid state, and having the glass transition temperature at 70º C would avoid changing the state of the filler material by introducing into the body of the patient when it is implanted in the body of the patient thus keeping the device stable while it is in the patient’s body.
Additionally, like Dahl et al., Laghi discloses an implantable medical device using a liquid filler material that solidifies upon cooling and teach the liquid filler material is a gel filler material comprising a styrene-ethylene-butylene-styrene (SEBS) thermoplastic block copolymer (see [0041]) and a plasticizing oil (see [0042]) in order to provide a known and workable example of a gel filler material for an implantable medical device.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Dahl et al. in view of Official Notice, as taught by Laghi, to make the liquid filler material from a gel filler material comprising a styrene-ethylene-butylene-styrene (SEBS) thermoplastic block copolymer and a plasticizing oil in order to provide a known and workable example of a gel filler material for an implantable medical device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON F ROANE whose telephone number is (571)272-4771. The examiner can normally be reached generally Mon-Fri 8am-9pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AARON F ROANE/Primary Examiner, Art Unit 3792