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
This final action is in response to the amendment filed on 12/19/2025. The same art of record is applied in this final action as in the nonfinal action dated 08/20/2025
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Zocchi (US 8,535,619 B2) in view of Smith et al. (US 2012/0110824 A1).
Zocchi discloses an enclosure for an electronic medical device (Fig.1:11; and col.1, lines 5-8), the enclosure comprising:
a case (Fig.1:13) configured to receive an electronic medical device (Fig.2:15) configured to display glucose concentration information (col.6, lines 48-55 and col.62-67) and having a display screen (Fig.3:49), the case being sized and configured to substantially conform to a shape of the electronic medical device and including a window portion (col.7, lines 17-23) for a user to view the display screen of the electronic medical device;
wherein the window portion is recessed (Fig.3:49) from a front surface of the case;
the window portion (Fig.3:49) in Zocchi et al. is capable of being configured to resist moisture penetration into the case; and
an opening (the case 13 is in the opened position as shown in Fig.2 where the opening is closed using zipper 33) in the case sized and configured to allow for insertion of the electronic medical device (Fig.2:15) into the case and removal of the electronic medical device from the case.
Zocchi appears silent to disclose that the case comprises an elastic polymer material that substantially conforms to the shape of the electronic medical device when the electronic medical device is inserted into the case.
Smith et al. discloses an insertion package (Fig.8A:512) for inserting a plurality of insertable components of a medical device [0067]. The insertion package is made of elastic polymer material [0083] such as polyethylene (polyethylene is capable of resuming its normal shape after being distorted or contracted) that conforms to the shape of the electronic medical device when the electronic medical device is inserted in order vacuum out the air prior to sealing [0083]. 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 to add Smith et al. package to Zocchi case in order vacuum out the air prior to sealing so that the plastic material is heat-shrunk.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Zocchi (US 8,535,619 B2) in view of Smith et al. (US 2012/0110824 A1) and further in view of Moller et al. (US 2005/0074368 A1).
Zocchi discloses an enclosure for an electronic medical device (Fig.1:11; and col.1, lines 5-8), the enclosure comprising:
a case (Fig.1:13) configured to receive an electronic medical device (Fig.2:15) configured to display glucose concentration information (col.6, lines 48-55 and col.62-67) and having a display screen (Fig.3:49), the case being sized and configured to substantially conform to a shape of the electronic medical device and including a window portion (col.7, lines 17-23) for a user to view the display screen of the electronic medical device;
the window portion (Fig.3:49) in Zocchi et al. is capable of being configured to resist moisture penetration into the case; and
an opening (the case 13 is in the opened position as shown in Fig.2 where the opening is closed using zipper 33) in the case sized and configured to allow for insertion of the electronic medical device (Fig.2:15) into the case and removal of the electronic medical device from the case.
Zocchi appears silent to disclose that the case comprises an elastic polymer material that substantially conforms to the shape of the electronic medical device when the electronic medical device is inserted into the case. And also appears silent to teach that the window portion is recessed from a front surface of the case.
Smith et al. discloses an insertion package (Fig.8A:512) for inserting a plurality of insertable components of a medical device [0067]. The insertion package is made of elastic polymer material [0083] such as polyethylene (polyethylene is capable of resuming its normal shape after being distorted or contracted) that conforms to the shape of the electronic medical device when the electronic medical device is inserted in order vacuum out the air prior to sealing [0083]. 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 to add Smith et al. package to Zocchi case in order vacuum out the air prior to sealing so that the plastic material is heat-shrunk.
Smith et al. appears silent to teach that the window portion is recessed from a front surface of the case.
Moller et al. discloses a rigid [0022] removable cover (Fig.1:20) for a glucose meter where the window portion (Fig.1:72 and 48) is recessed from a front surface (Fig.1:70) of the case so that the cover can protect the blood glucose meter from becoming damaged from an impact [0006]. 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 to add Moller et al. rigid cover to the combined Zocchi blood glucose monitoring kit in order to provide protection to the blood meter from damages caused by impacts.
Claims 2-6, 9-12, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Zocchi (US 8,535,619 B2) in view of Smith et al. (US 2012/0110824 A1).
Regarding claims 2-3, Zocchi appears silent to disclose using openings having adhesive covers.
Smith et al. discloses an insertion package (Fig.7:400) for inserting a plurality of insertable components into a medical device [0067]. The insertion package includes multiple openings (Fig.7:410) with adhesive covers (Fig.7:420) so that the sterility of the medical device is not compromised [0067]. 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 to add Smith et al. package to Zocchi case so that the sterility of the blood glucose monitoring device is not compromised.
Regarding claims 4-6, Zocchi appears silent to teach the use of having openings with adhesive peelable covers.
Smith et al. discloses an insertion package (Fig.7:400) for inserting a plurality of insertable components into a medical device [0067]. The insertion package includes multiple openings (Fig.7:410) with adhesive covers (Fig.7:420) so that the sterility of the medical device is not compromised [0067]. Smith et al. further discloses the use of plastic peelable films [0038].
As to the issue of choosing peelable films with various different strengths, one of ordinary skill in the art would readily recognize that depending on the size/type of the medical device and the locations of the openings, one will use peelable adhesive covers with greater strengths where the openings are under strain vs openings that are not. 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 to add Smith et al. package to Zocchi case so that the sterility of the blood glucose monitoring device is not compromised.
Regarding claims 9-12, Zocchi appears silent to teach the use of polyethylene, and also appears silent to teach the use of different materials having different stiffness.
Smith et al. discloses an insertion package (Fig.7:400) for inserting a plurality of insertable components into a medical device [0067]. The insertion package includes multiple openings (Fig.7:410) with adhesive covers (Fig.7:420) so that the sterility of the medical device is not compromised [0067]. Smith et al. further discloses the use of polyethylene [0083] where package is made up of different materials with different stiffness values [0083] so that certain parts of the package surround the device while other parts cover insertion recesses [0083].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 to add Smith et al. package to Zocchi case so that the sterility of the blood glucose monitoring device is not compromised.
Regarding claims 14-15, Zocchi appears silent to teach the use of different materials and also appears silent to disclose that the enclosure includes openings.
Smith et al. discloses an insertion package (Fig.7:400) for inserting a plurality of insertable components into a medical device [0067]. The insertion package includes multiple openings (Fig.7:410) with adhesive covers (Fig.7:420) so that the sterility of the medical device is not compromised [0067]. Smith et al. further that the package is made up of different materials for use with different portions of the insertion package [0083] so that certain parts of the package surround the device while other parts cover insertion recesses [0083].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 to add Smith et al. package to Zocchi case so that the sterility of the blood glucose monitoring device is not compromised.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Zocchi (US 8,535,619 B2) in view of Smith et al. (US 2012/0110824 A1) as applied to claim 7, and further in view of Varela (US 2010/0004522 A1).
The combined Zocchi enclosure appears silent to disclose that the communication port is a USB port.
Valera discloses a wearable blood glucose ([0003]: Fig.5:82) that includes a USB port (Fig.8:128; [0120]) in order to obtain data from an external computer [0120]. 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 to add Valera’s USB port to the combined Zocchi enclosure in order to be able obtain data from an external computer.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Zocchi (US 8,535,619 B2) in view of Smith et al. (US 2012/0110824 A1) as applied to claim 10, and further in view of Chemberlen (US 5,584,409).
The combined Zocchi enclosure appears silent to teach the use polycarbonate and acrylonitrile butadiene styrene.
Chemberlen discloses one direction valves for packages that are used in medical applications (col.1, lines 5-10 and col.2, lines 14-16) that include polycarbonate and acrylonitrile butadiene styrene (col.6, lines 7-10) in order to provide packages that can be utilized for a wide variety of industrial products, medical type products and the like (col.5, lines 33-38). 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 to add polycarbonate and acrylonitrile butadiene styrene to the combined Zocchi enclosure in order to provide packages that can be utilized for a wide variety of industrial products, medical type products and the like.
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Zocchi (US 8,535,619 B2) in view of in view of Smith et al. (US 2012/0110824 A1) as applied to claim 1, and further in view of Harding et al. (US 5,454,896).
Regarding claims 16-17, the combined Zocchi enclosure appears silent to disclose the use of openings having the shape of slits.
Harding et al. teaches processes of attaching a flexible inner bag to the inside of a squeeze bottle dispenser (col.1, lines 7-10; and Fig.1:10) where the flexible inner bag includes a hole in the shape of a cross-shaped slit (col.4, lines 50-56) in order to provide a hole when the slit flaps bend (col.4, lines 56-58). 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 to add Harding et al. cross-shaped slit to the combined Zocchi enclosure in order to provide a hole when the slit flaps bend.
Regarding claim 18, Zocchi blood glucose monitoring device (Fig.2:15) is configured to display continuous glucose concentration data over a time period (col.7, lines 4-23).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 2012/0110824 A1) in view of Zocchi (US 8,535,619 B2).
Regarding claim 19, Smith et al. discloses a method [0047] for reprocessing a reusable electronic medical device ([0027]; Fig.2:100), the method comprising:
receiving an electronic medical device from a first user (the surgical device in Fig.2 is a reusable electronic device), wherein the electronic medical device is contained in a first protective enclosure (Fig.9B:690), that is sized and configured to substantially conform to a shape of the electronic medical device;
wherein the window portion is recessed (Fig.3:49) from a front surface of the first protective enclosure;
the window portion (Fig.3:49) in Zocchi et al. is capable of being configured to resist moisture penetration into the first protective enclosure;
removing the electronic medical device from the first protective enclosure (Fig.8A:510 and 520; contaminated medical devices that are to be reprocessed are deemed to be maintained in a protective enclosure until they are to be sterilized);
inserting the electronic medical device [0067] into a second protective enclosure through an opening in the second protective enclosure (Fig.7:400);
adhering a cover [0071] to the second protective enclosure over the opening; and
providing the electronic medical device contained within the second protective enclosure to a second user ([0074]; the medical device is provided to a medical facility for use).
Smith et al. teaches that all different types medical devices [0027] including devices having sensors. However, Smith et al. appears silent to disclose that the medical device is a glucose monitoring device.
Zocchi discloses a blood monitoring kit (Fig1:11) where the electronic medical device being configured to display glucose concentration information (col.1, lines 5-8) and having a display screen (Fig.3:49), wherein the electronic medical device (Fig.2:15) is contained in a first protective enclosure (Fig.2:13) and including a window portion (col.7, lines 18-23) for a user to view the display screen of the electronic medical device. Zocchi explains the importance of blood glucose monitoring devices in preventing patients from experiencing serious medical complications (col.1, lines 17-22). 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 to add blood glucose monitoring devices to Smith et al. method since blood glucose monitoring devices are critical in preventing patients from experiencing serious medical complications.
Regarding claim 20, Smith et al. teaches creating a disinfected filed [0047-0047], wherein removing the electronic medical device from the first protective enclosure (Fig.8A:510 and 520; contaminated medical devices that are to be reprocessed are deemed to be maintained in a protective enclosure until they are to be sterilized), and then inserting the electronic medical device [0067] into a second protective enclosure through an opening in the second protective enclosure (Fig.7:400) are performed in the disinfected field (the packaged contaminated medical device is removed from the first package and is then sterilized [0047] and afterwards is placed in the second package in the disinfected filed).
Claims 2-6, 9-12, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Zocchi (US 8,535,619 B2) in view of Smith et al. (US 2012/0110824 A1) and further in view of Moller et al. (US 2005/0074368 A1).
Regarding claims 2-3, the Zocchi and Moller et al. enclosure appears silent to disclose using openings having adhesive covers.
Smith et al. discloses an insertion package (Fig.7:400) for inserting a plurality of insertable components into a medical device [0067]. The insertion package includes multiple openings (Fig.7:410) with adhesive covers (Fig.7:420) so that the sterility of the medical device is not compromised [0067]. 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 to add Smith et al. package to the combined Zocchi case so that the sterility of the blood glucose monitoring device is not compromised.
Regarding claims 4-6, the Zocchi and Moller et al. enclosure appears silent to teach the use of having openings with adhesive peelable covers.
Smith et al. discloses an insertion package (Fig.7:400) for inserting a plurality of insertable components into a medical device [0067]. The insertion package includes multiple openings (Fig.7:410) with adhesive covers (Fig.7:420) so that the sterility of the medical device is not compromised [0067]. Smith et al. further discloses the use of plastic peelable films [0038].
As to the issue of choosing peelable films with various different strengths, one of ordinary skill in the art would readily recognize that depending on the size/type of the medical device and the locations of the openings, one will use peelable adhesive covers with greater strengths where the openings are under strain vs openings that are not. 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 to add Smith et al. package to the combined Zocchi case so that the sterility of the blood glucose monitoring device is not compromised.
Regarding claims 9-12, the Zocchi and Moller et al. enclosure appears silent to teach the use of polyethylene, and also appears silent to teach the use of different materials having different stiffness.
Smith et al. discloses an insertion package (Fig.7:400) for inserting a plurality of insertable components into a medical device [0067]. The insertion package includes multiple openings (Fig.7:410) with adhesive covers (Fig.7:420) so that the sterility of the medical device is not compromised [0067]. Smith et al. further discloses the use of polyethylene [0083] where package is made up of different materials with different stiffness values [0083] so that certain parts of the package surround the device while other parts cover insertion recesses [0083].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 to add Smith et al. package to the combined Zocchi case so that the sterility of the blood glucose monitoring device is not compromised.
Regarding claims 14-15, the Zocchi and Moller et al. enclosure appears silent to teach the use of different materials and also appears silent to disclose that the enclosure includes openings.
Smith et al. discloses an insertion package (Fig.7:400) for inserting a plurality of insertable components into a medical device [0067]. The insertion package includes multiple openings (Fig.7:410) with adhesive covers (Fig.7:420) so that the sterility of the medical device is not compromised [0067]. Smith et al. further that the package is made up of different materials for use with different portions of the insertion package [0083] so that certain parts of the package surround the device while other parts cover insertion recesses [0083].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 to add Smith et al. package to the combined Zocchi case so that the sterility of the blood glucose monitoring device is not compromised.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Zocchi (US 8,535,619 B2) in view of Smith et al. (US 2012/0110824 A1) and Moller et al. (US 2005/0074368 A1) as applied to claim 1, and further in view of Varela (US 2010/0004522 A1).
The combined Zocchi enclosure appears silent to disclose that the communication port is a USB port.
Valera discloses a wearable blood glucose ([0003]: Fig.5:82) that includes a USB port (Fig.8:128; [0120]) in order to obtain data from an external computer [0120]. 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 to add Valera’s USB port to the combined Zocchi enclosure in order to be able obtain data from an external computer.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Zocchi (US 8,535,619 B2) in view of Smith et al. (US 2012/0110824 A1) and Moller et al. (US 2005/0074368 A1) as applied to claim 10, and further in view of Chemberlen (US 5,584,409).
The combined Zocchi enclosure appears silent to teach the use polycarbonate and acrylonitrile butadiene styrene.
Chemberlen discloses one direction valves for packages that are used in medical applications (col.1, lines 5-10 and col.2, lines 14-16) that include polycarbonate and acrylonitrile butadiene styrene (col.6, lines 7-10) in order to provide packages that can be utilized for a wide variety of industrial products, medical type products and the like (col.5, lines 33-38). 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 to add polycarbonate and acrylonitrile butadiene styrene to the combined Zocchi enclosure in order to provide packages that can be utilized for a wide variety of industrial products, medical type products and the like.
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Zocchi (US 8,535,619 B2) in view of Smith et al. (US 2012/0110824 A1) and Moller et al. (US 2005/0074368 A1) as applied to claim 1, and further in view of Harding et al. (US 5,454,896).
Regarding claims 16-17, the combined Zocchi appears silent to disclose the use of openings having the shape of slits.
Harding et al. teaches processes of attaching a flexible inner bag to the inside of a squeeze bottle dispenser (col.1, lines 7-10; and Fig.1:10) where the flexible inner bag includes a hole in the shape of a cross-shaped slit (col.4, lines 50-56) in order to provide a hole when the slit flaps bend (col.4, lines 56-58). 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 to add Harding et al. cross-shaped slit to the combined Zocchi enclosure in order to provide a hole when the slit flaps bend.
Regarding claim 18, Zocchi blood glucose monitoring device (Fig.2:15) is configured to display continuous glucose concentration data over a time period (col.7, lines 4-23).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 2012/0110824 A1) in view of Zocchi (US 8,535,619 B2), and further in view of Moller et al. (US 2005/0074368 A1).
Regarding claim 19, Smith et al. discloses a method [0047] for reprocessing a reusable electronic medical device ([0027]; Fig.2:100), the method comprising:
receiving an electronic medical device from a first user (the surgical device in Fig.2 is a reusable electronic device), wherein the electronic medical device is contained in a first protective enclosure (Fig.9B:690), that is sized and configured to substantially conform to a shape of the electronic medical device;
removing the electronic medical device from the first protective enclosure (Fig.8A:510 and 520; contaminated medical devices that are to be reprocessed are deemed to be maintained in a protective enclosure until they are to be sterilized);
inserting the electronic medical device [0067] into a second protective enclosure through an opening in the second protective enclosure (Fig.7:400);
adhering a cover [0071] to the second protective enclosure over the opening; and
providing the electronic medical device contained within the second protective enclosure to a second user ([0074]; the medical device is provided to a medical facility for use).
Smith et al. teaches that all different types medical devices [0027] including devices having sensors. However, Smith et al. appears silent to disclose that the medical device is a glucose monitoring device, and appears to teach that the window portion is recessed and is configured to resist moisture penetration into the device.
Zocchi discloses a blood monitoring kit (Fig1:11) where the electronic medical device being configured to display glucose concentration information (col.1, lines 5-8) and having a display screen (Fig.3:49), wherein the electronic medical device (Fig.2:15) is contained in a first protective enclosure (Fig.2:13) and including a window portion (col.7, lines 18-23) for a user to view the display screen of the electronic medical device. Zocchi explains the importance of blood glucose monitoring devices in preventing patients from experiencing serious medical complications (col.1, lines 17-22). In addition, the window portion (Fig.3:49) in Zocchi et al. is capable of being configured to resist moisture penetration into the case. 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 to add blood glucose monitoring devices to Smith et al. method since blood glucose monitoring devices are critical in preventing patients from experiencing serious medical complications.
The combined Smith et al. method appears silent to teach that the window portion is recessed from a front surface of the case.
Moller et al. discloses a rigid [0022] removable cover (Fig.1:20) for a glucose meter where the window portion (Fig.1:72 and 48) is recessed from a front surface (Fig.1:70) of the case so that the cover can protect the blood glucose meter from becoming damaged from an impact [0006]. 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 to add Moller et al. rigid cover to the combined Smith et al. method in order to provide protection to the blood meter from damages caused by impacts.
Regarding claim 20, Smith et al. teaches creating a disinfected filed [0047-0047], wherein removing the electronic medical device from the first protective enclosure (Fig.8A:510 and 520; contaminated medical devices that are to be reprocessed are deemed to be maintained in a protective enclosure until they are to be sterilized), and then inserting the electronic medical device [0067] into a second protective enclosure through an opening in the second protective enclosure (Fig.7:400) are performed in the disinfected field (the packaged contaminated medical device is removed from the first package and is then sterilized [0047] and afterwards is placed in the second package in the disinfected filed).
Response to Arguments
It is noted that no arguments were presented in the Remarks section filed on 12/19/2025. Applicant should submit an argument under the heading “Remarks” pointing out disagreements with the examiner’s contentions. Applicant must also discuss the references applied against the claims, explaining how the claims avoid the references or distinguish from them.
Applicant amended claim 1 by adding, “wherein the case comprises an elastic polymer material, wherein the elastic polymer material substantially conforms to the shape of the electronic medical device when the electronic medical device is inserted into the case.” In this final action, Smith et al. discloses an insertion package (Fig.8A:512) that is made of elastic polymer material [0083] such as polyethylene (polyethylene is capable of resuming its normal shape after being distorted or contracted) that conforms to the shape of the electronic medical device when the electronic medical device is inserted in order vacuum out the air prior to sealing [0083]. 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 to add Smith et al. package to Zocchi case in order vacuum out the air prior to sealing so that the plastic material is heat-shrunk.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MONZER R CHORBAJI whose telephone number is (571)272-1271. The examiner can normally be reached M-F 5:30-12:00 and 6:00-9:00.
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, Jill J Warden can be reached at (571)272-1267. 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.
/MONZER R CHORBAJI/Primary Examiner, Art Unit 1799