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 .
Drawings
The drawings are objected to because “elastic membranes” is referred by reference character “63”, but should be “62”, and “adhesive layer” of the instrument tray is referred by reference character “51”, but should be “52”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "4", “41", and “42” have been used to designate “adhesive layer” of the attachment portion. It appears that it should be reference character “42”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
In paragraph [0009], “cover layer is removed ant the tray” should be changed to “and”
In paragraph [0034], “adhesive later” should read “adhesive layer”.
Appropriate correction is required.
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 13 and 19 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.
Claim 13 recites the limitations "the microscope connection", “the view window”, “the rim” and “the microscope”. Claim 10 does not mention any of those limitations. There is insufficient antecedent basis for these limitations in the claim. It appears that claim 13 should be dependent on claim 11.
Claim 19 recites the limitations “the cover layer”, “the attachment portion”, “the adhesive layer”, “the instrument tray”, and “the medical instruments”. Claim 11 does not mention any of those limitations. There is insufficient antecedent basis for these limitations in the claim.
Claim Rejections - 35 USC § 102
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.
Claims 1-3, 5, 7, 9 and 18 are rejected under 35 U.S.C 103 as being anticipated by Kriek (US 20060021621 A1).
Regarding claim 1, Kriek teaches a surgical sterile field system comprising:
an inflatable flexible enclosure that is transparent in at least part of its expanse (“bubble may be filled with air or gas to inflate”, paragraph [0019], “flexible membrane”, paragraph [0016], “enclosure may be optically clear or transparent”, paragraph [0023]; enclosure 1, Fig. 1):
a pair of gloves (“at least two, glove attachments”, paragraph [0065]; glove 42, glove attachments 41, Fig. 6B) that are hermetically formed and sealed on a wall of the enclosure to allow access to an inside of the enclosure near a surgical site; and
an incision site of a size corresponding to the required surgical area, said incision site having an adhesive covering at least its exterior periphery, which adhesive is attachable to the skin of the patient adjacent the surgical site (“drape may comprise a sheet having an opening for surrounding the area of the intended incision and a cover over the opening for sealing the opening. The joining means may comprise an adhesive layer on the cover”, paragraph [0030]), and a peelable cover over the adhesive at the incision site that guards against contact with the adhesive until placed on the patient, wherein upon removal of the cover and application of the incision site of the enclosure to the patient (“adhesive tape is covered with a backing which may be peeled off to expose the tape”, paragraph [0057]; adhesive tape 11, backing 12, Fig. 3), the enclosure can be cut by a surgical instrument to expose the surgical site while maintaining a sterile environment at the surgical site (“enclosure…is then cut away by the surgeon”, paragraph [0068], paragraph [0018]).
Regarding claim 2, Kriek teaches the system further including at least two attachment portions formed on an outer surface of the wall of the enclosure (“one or more windows…attached to the enclosure has a membrane on its surface and an adhesive tape”, paragraph [0055], “joining means comprises an adhesive…provided on a wall member of the sterile environment”, paragraph [0010],), wherein
each of the attachment portions is composed of an adhesive layer and a cover layer stacked on the adhesive layer (“adhesive has a backing layer which may be peeled off”, paragraph [0010]; adhesive 23, backing 24; Fig. 2B), and
the cover layer can be manually removed from the adhesive layer.
Regarding claim 3, Kriek teaches the enclosure having a filter through which a sterilized air is supplied to inflate the enclosure (“enclosure…filled with sterile air…air may be continually recirculated through a sterilizing filter”, paragraph [0022]).
Regarding claim 5, Kriek teaches the system further comprising an instrument tray that is configured to contain sterilized medical instruments,
wherein one of the at least two attachment portions is configured to attach to the instrument tray (paragraphs [0060] and [0070]; second attachment 31, opening 37, adhesive tape 38, removable backing 39, Fig. 5), and
another of the at least two attachment portions is configured to directly attach to an incision site of a patient (paragraph [0030]; adhesive tape 11, backing 12, opening 9, Fig. 3).
Regarding claim 7, Kriek teaches the instrument tray comprising a transparent layer, an adhesive layer, and a cover layer stacked on a top of the instrument tray in this order (transparent cover 36, adhesive tape 38, backing 39, Fig. 5);
The cover layer can be manually removed from the adhesive layer and the adhesive layer of the tray can be mounted on the adhesive layer of the one attachment portion (paragraph [0070]; adhesive tape 38, backing 39, opening 37, cover 36, Fig. 5), and a cut can be made through both adhesive layers to allow access to the medical instruments from inside the enclosure (“by cutting, to connect the enclosure and package…to allow access to the surgical instruments from inside the enclosure”, paragraph [0007]).
Regarding claim 9, Kriek teaches the system further comprising an additional pair of gloves that are hermetically formed on the wall of the enclosure (paragraph [0065]; glove 42, glove attachments 41, Fig. 6B).
Regarding claim 18, Kriek teaches a method comprising the steps of:
Inflating the enclosure by supplying sterilized air into the enclosure (“enclosure is usually filled with sterile air…for inflation”, paragraph [0022]);
Removing the cover layer of the attachment portion to expose the adhesive layer thereof (“adhesive tape has a backing which may be peeled off to expose the tape”, paragraph [0055]; adhesive tape 23, backing 24, Fig. 2B);
Removing the cover layer of the instrument tray to expose the adhesive layer thereof (“cover is provided over the surgical instruments which has an opening…sealed with a membrane and surrounded by an adhesive tape…removable backing is provided over the adhesive tape”, paragraph [0060]; cover 36, adhesive tape 38, backing 39, Fig. 5);
Attaching the instrument tray to the enclosure (“package containing surgical instruments may be joined to the enclosure”, paragraph [0017]; surgical instrument tray in Fig. 5); and
Simultaneously cutting away the wall of the enclosure together with the adhesive layer of the attachment portion and the adhesive layer and the transparent layer of the instrument tray so that the medical instruments in the instrument tray can be exposed inside the enclosure (“surgeon perforates the membrane of the enclosure adjacent the opening…to gain access to the surgical instruments under the cover”, paragraph [0070]; cover 36, adhesive tape 38, backing 39, Fig. 5).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kriek in view of Thomas et al. (US 5083558 A).
Regarding claim 4, Kriek teaches all the limitations of claim 1, but does not teach specifically the entry port and its structure. Kriek does teach a pump and filter arrangement to provide sterile air in order to maintain sterility within the enclosure (paragraph [0022]).
However, Thomas et al. teaches the enclosure having an entry port formed on the wall thereof (port 108, Fig. 1), the entry port comprises a tubal body (“flexible tube”, Col. 6, lines 65 – Col. 7, lines 1-7), a cap (port can be open and closed) and at least two elastic membranes (“resilient membranes…closes resiliently via elastic”, Col. 6, lines 65 – Col. 7, lines 1-7); and
wherein items can be entered into the enclosure without causing a loss of sterilization (“particle-free air delivered in…laminar flow pattern in a partial enclosure through which surgeons can access a surgical subject…surgeons hands and forearms enter the enclosure”, Col. 3, lines 30-35).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the enclosure of Kriek with the entry port of Thomas et al. in order to ensure that the surgical sterile field enclosure remains a sterile environment while the surgeon is operating on a patient, whether that is inserting their arms into the enclosure to operate, or moving the patient in and out of the enclosure.
Regarding claim 14, A modified Kriek in view of Thomas teaches the limitations of claim 4.
Furthermore, both Kriek and Thomas et al. teach the item as mentioned in claim 4, being sterile air (Col. 3, lines 36-41 (Thomas et al.), paragraph [0022] (Kriek)).
Regarding claim 15, the modified surgical sterile field system of Kriek in view of Thomas et al. further teaches the item as mentioned in claim 4, being a fluid (“first attachment carries a container which contains a fluid…for administering to the patient, in a sterile environment”, paragraph [0059]; container 32, Fig. 5) or power line (attachment 30, Fig. 5).
Claims 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kriek.
Regarding claim 6 and 8, Kriek teaches the enclosure and the adhesive layer, as well as the transparent layer and the adhesive layer of the instrument tray being made of plastic that can be penetrated by a surgical knife (“enclosure…may be of a plastics material”, paragraph [0019]). It would be reasonable to make the adhesive layers and transparent layers a plastic material as well to be uniform with the enclosure, and plastic materials can be penetrated by a surgical knife or any sharp object. It would have been obvious to one having ordinary skill in the art at the filing date of the invention to utilize a plastic adhesive since the Examiner takes Official Notice that plastic adhesive materials are widely known and utilized and would be within the level of ordinary skill in the art.
Claims 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kriek in view of Okajima et al. (US 20220039908 A1).
Regarding claim 10, Kriek does teach all the limitations of claim 3, but not the filter being a HEPA filter.
However, Okajima et al. teaches a surgical sterile field system wherein the filter is a HEPA filter (“a HEPA filter…may be connected to a portable enclosure via sterile flexible tubing”, paragraph [0084]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the surgical sterile field system of Kriek that does have a sterilizing filter with the system of Okajima et al. which further includes more specifically, a HEPA filter. HEPA filters help trap bacteria, viruses, and other contaminants and pollutants, ensuring a sterile environment for the enclosed space for surgical operations.
Regarding claim 12, Kriek teaches all the limitations of claim 1, but not a magnifying glass within the enclosure.
However, Okajima et al. teaches a magnifying glass located within the enclosure and configured to magnify an incision site of a patient (“one or more magnifying glass are built-in”, paragraph [0024]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the enclosure with the view windows of Kriek with the magnifying glass component of Okajima et al. in order to allow a more precise and magnified view of an incision site of a patient which is convenient and helpful to the surgeon.
Claims 11 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kriek in view of Kerns et al. (US 20150238264 A1).
Regarding claim 11, Kriek teaches all the limitations of claim 1, but does not teach a microscope or microscope connection formed on the wall of the enclosure.
However, Kerns et al. teaches a microscope connection formed on the wall of the enclosure (“surgical drape system can comprise a hole in the drape for a microscope”, paragraph [0044]; microscope connection 108, Fig. 1C), and wherein the microscope connection is configured to attach to a microscope.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the enclosure of Kriek with the microscope and microscope connection of Kerns et al. in order to provide a better view of the incision site of a patient, especially when performing ophthalmic surgery where it is crucial.
Regarding claim 19, a modified surgical sterile field system of Kriek in view of Kerns et al. teaches the limitations of claim 11 and further teaches
Inflating the enclosure by supplying sterilized air into the enclosure (“enclosure is usually filled with sterile air…for inflation”, paragraph [0022]);
Removing the cover layer of the attachment portion to expose the adhesive layer thereof (“adhesive tape has a backing which may be peeled off to expose the tape”, paragraph [0055]; adhesive tape 23, backing 24, Fig. 2B);
Removing the cover layer of the instrument tray to expose the adhesive layer thereof (“cover is provided over the surgical instruments which has an opening…sealed with a membrane and surrounded by an adhesive tape…removable backing is provided over the adhesive tape”, paragraph [0060]; cover 36, adhesive tape 38, backing 39, Fig. 5);
Attaching the instrument tray to the enclosure (“package containing surgical instruments may be joined to the enclosure”, paragraph [0017]; surgical instrument tray in Fig. 5); and
Simultaneously cutting away the wall of the enclosure together with the adhesive layer of the attachment portion and the adhesive layer and the transparent layer of the instrument tray so that the medical instruments in the instrument tray can be exposed inside the enclosure (“surgeon perforates the membrane of the enclosure adjacent the opening…to gain access to the surgical instruments under the cover”, paragraph [0070]; cover 36, adhesive tape 38, backing 39, Fig. 5).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kriek in view of Okajima et al. and further in view of Kerns et al. (US 20150238264 A1).
Regarding claim 13, the modified surgical sterile field system of Kriek in view of Okajima et al. do not teach the limitations of claim 13.
However, Kerns et al. teaches the microscope connection comprising a view window (opening 108; Fig. 1C) and a rim that surrounds the view window (circular rim around opening 108, Fig. 1C), the rim is configured to be connected to the microscope and
the view window is configured to be in alignment with an incision site of a patient (paragraphs [0053] and [0054]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified enclosure of Kriek in view of Okajima et al. with the view window and rim of the microscope connection of Kerns et al. in order to ensure that the connection between the microscope and sterile enclosure is secure and aligned with the incision site of a patient.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kriek in view of Brennan et al. (US 20150144514 A1).
Regarding claim 16, Kriek does teach all the limitations of claim 5, but does not disclose one of the medical instruments being an ultrasonic phacoemulsification handpiece.
However, Brennan et al. teaches a system for ophthalmic surgery wherein at least one of the medical instruments is an ultrasonic phacoemulsification handpiece (paragraph [0104]; handpieces 110, Fig. 4A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the surgical sterile field system of Kriek with ultrasonic handpiece of Burns et al., making it readily available for ophthalmic surgery.
Regarding claim 17, Kriek does teach all the limitations of claim 5, but does not disclose one of the medical instruments being a laser handpiece.
However, Brennan et al. teaches one of the medical instruments being a laser handpiece (paragraph [0116]; handpieces 110, Fig. 4A) that emits laser energy for at least softening a cataract (paragraph [0191]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the surgical sterile field system of Kriek with the laser handpiece of Brennan et al., making it readily available for ophthalmic surgery and breaking up or softening a cataract.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARA LINH TRAN whose telephone number is (571)272-3598. The examiner can normally be reached 7:30am-5:00pm M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at 5712724233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.L.T./Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791