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 .
Drawings
The drawings are objected to because they are presented as photographs, which are unclear, making the components indiscernible. The drawings should be presented as black and white line drawings. 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.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “first flange further comprises a first outer perimeter portion and a second outer perimeter portion” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: from claims 2-4, the limitations “the first flange further comprises a first outer perimeter portion and a second outer perimeter portion; wherein the first outer perimeter portion and the second outer perimeter portion are oriented in opposing directions when in the neutral position; wherein the first outer perimeter portion and the second outer perimeter portion are oriented in substantially the same direction when in the flexed position” are not disclosed in the specification. Paragraph 0038 states “(i.e., the outer perimeter portions of the first flange 14 move from facing opposite directions to facing substantially the same direction)”, however the outer perimeter portions are only mentioned in this one instance and are not recited anywhere else in the specification nor given a reference number.
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.
Claim(s) 1-7 and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Balboa et al. (US 20210236163 A1).
Regarding claim 1, Balboa discloses a cannula (200), comprising:
a first flange (220) positioned at a first end (Figure 2A; Paragraph 0018);
a second flange (230) positioned at a second end (Figure 2A; Paragraph 0017); and
an elongated cannulated body (205) extending along a central longitudinal axis and having a working portal (210) extending therebetween (Figure 2A);
wherein:
the first flange is flexible and is configured to move from a neutral position to a flexed position (Figure 1; Paragraph 0012; 0017);
the first flange includes:
a first aperture (opening into 210), wherein the first aperture of the first flange is axially in line with the working portal (Figure 2A; Paragraph 0017);
and the second flange includes:
a first aperture (opening into 210), wherein the first aperture of the second flange is axially in line with the working portal and the first aperture of the first flange (Figure 2A); and
a second aperture (one of 232) and a third aperture (second of 232), wherein the second aperture and third aperture of the second flange are each adjacently positioned to the first aperture (Figure 2A; Paragraph 0017).
Regarding claim 2, Balboa further discloses wherein the first flange further comprises a first outer perimeter portion (right side of 230) and a second outer perimeter portion (left side of 230) (Figure 2A).
Regarding claim 3, Balboa further discloses wherein the first outer perimeter portion and the second outer perimeter portion are oriented in opposing directions when in the neutral position (Figure 2A; Paragraph 0012).
Regarding claim 4, Balboa further discloses wherein the first outer perimeter portion and the second outer perimeter portion are oriented in substantially the same direction when in the flexed position (Paragraph 0012) (Balboa states “In use, the cannula is placed in the tissue through an incision such that the distal flange flexes open beneath the tissue as it is placed in position”).
Regarding claim 5, Balboa further discloses a third flange (222) positioned along the cannulated body and between the first flange and the second flange (Figure 2A; Paragraph 0017).
Regarding claim 6, Balboa further discloses wherein the third flange further comprises a central aperture (opening coinciding with 210) and one or more elongated apertures (232) formed therethrough (Figure 2A; Paragraph 0017).
Regarding claim 7, Balboa further discloses wherein the third flange is moveable about the cannulated body (flange 222 is removable, therefore would be movable about the cannulated body, at least during the process of removal) (Paragraph 0018).
Regarding claim 9, Balboa further discloses wherein the elongated apertures of the third flange are configured to axially align with the second and third apertures of the second flange (Figure 2A; Paragraph 0017).
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.
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(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Balboa.
Regarding claim 8, Balboa discloses the cannula of claim 7, but fails to explicitly disclose wherein the cannulated body further comprises a plurality of threads integrally formed therewith that correspond to a plurality of threads integrally formed with the central aperture of the third flange to enable the third flange to rotate about the cannulated body and move closer to the first flange or the second flange.
However, an alternative embodiment of Balboa is directed to a cannula (400) and teaches wherein the cannulated body further comprises a plurality of threads (407) integrally formed therewith that correspond to a plurality of threads integrally formed with the central aperture (a pawl of flange 410) of the third flange (410) to enable the third flange to rotate about the cannulated body and move closer to the first flange (420) (Figure 4A-B; Paragraph 0020).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Balboa by incorporating wherein the cannulated body further comprises a plurality of threads integrally formed therewith that correspond to a plurality of threads integrally formed with the central aperture of the third flange to enable the third flange to rotate about the cannulated body and move closer to the first flange or the second flange, as taught by an alternative embodiment of Balboa in order to allow for movement and fixed positioning of the flange along the length of the cannula (Paragraph 0020).
Claim(s) 10-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Balboa in view of Hamel (US 20050192486 A1).
Regarding claim 10, Balboa discloses a cannula system, comprising:
a cannula (200), comprising:
a first flange (220) positioned at a first end (Figure 2A; Paragraph 0018);
a second flange (230) positioned at a second end (Figure 2A; Paragraph 0017); and
an elongated cannulated body (205) extending along a central longitudinal axis and having a working portal (210) extending therebetween (Figure 2A);
wherein:
the first flange is flexible and is configured to move from a neutral position to a flexed position (Figure 1; Paragraph 0012; 0017);
the first flange includes:
a first aperture (opening into 210), wherein the first aperture of the first flange is axially in line with the working portal (Figure 2A; Paragraph 0017);
and the second flange includes:
a first aperture (opening into 210), wherein the first aperture of the second flange is axially in line with the working portal and the first aperture of the first flange (Figure 2A); and
a second aperture (one of 232) and a third aperture (second of 232), wherein the second aperture and third aperture of the second flange are each adjacently positioned to the first aperture (Figure 2A; Paragraph 0017).
Balboa fails to explicitly disclose a cannula and inserter system comprising: an inserter comprising: a pair of elongated flexible arms having a first end and a second end and connected at the first end, wherein the elongated flexible arms are configured to be positioned through the second and third apertures of the second flange and a second end of each of the elongated flexible arms are configured to be positioned in contacting relation to the first flange and move the first flange from the neutral position to the flexed position.
However, Hamel is directed to a cannula and inserter system (Paragraph 0087-88) and teaches an inserter (forceps or pliers) (Paragraph 0087; 0105) comprising: a pair of elongated flexible arms (arms of forceps or pliers) having a first end and a second end and connected at the first end (pliers and forceps are known to have arms connected at an end and are provided with another end) (Paragraph 0087), wherein the elongated flexible arms are configured to be positioned through the second and third apertures (72) of the second flange (71) and a second end of each of the elongated flexible arms are configured to be positioned in contacting relation to the first flange and move the first flange from the neutral position to the flexed position (Paragraph 0087) ("[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Balboa to include an inserter system comprising: an inserter comprising: a pair of elongated flexible arms having a first end and a second end and connected at the first end, wherein the elongated flexible arms are configured to be positioned through the second and third apertures of the second flange and a second end of each of the elongated flexible arms are configured to be positioned in contacting relation to the first flange and move the first flange from the neutral position to the flexed position, as taught by Hamel, as both references and the claimed invention are directed to cannulas. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Balboa with the teachings of Hamel by incorporating an inserter system comprising: an inserter comprising: a pair of elongated flexible arms having a first end and a second end and connected at the first end, wherein the elongated flexible arms are configured to be positioned through the second and third apertures of the second flange and a second end of each of the elongated flexible arms are configured to be positioned in contacting relation to the first flange and move the first flange from the neutral position to the flexed position in order to remove and position the flange according to the needs of a specific procedure (Hamel Paragraph 0087; 0105). Further, Balboa mentions “Perforations 232 are configured to aid removal of a corresponding flange”, however, does not mention how the flanges are removed (Paragraph 0017).
Regarding claim 11, Balboa further discloses wherein the first flange further comprises a first outer perimeter portion (right side of 230) and a second outer perimeter portion (left side of 230) (Figure 2A).
Regarding claim 12, Balboa further discloses wherein the first outer perimeter portion and the second outer perimeter portion are oriented in opposing directions when in the neutral position (Figure 2A; Paragraph 0012).
Regarding claim 13, Balboa further discloses wherein the first outer perimeter portion and the second outer perimeter portion are oriented in substantially the same direction when in the flexed position (Paragraph 0012) (Balboa states “In use, the cannula is placed in the tissue through an incision such that the distal flange flexes open beneath the tissue as it is placed in position”).
Regarding claim 14, Balboa further discloses a third flange (222) positioned along the cannulated body and between the first flange and the second flange (Figure 2A; Paragraph 0017).
Regarding claim 15, Balboa further discloses wherein the third flange further comprises a central aperture (opening coinciding with 210) and one or more elongated apertures (232) formed therethrough (Figure 2A; Paragraph 0017).
Regarding claim 16, Balboa further discloses wherein the third flange is moveable about the cannulated body (flange 222 is removable, therefore would be movable about the cannulated body, at least during the process of removal) (Paragraph 0018).
Regarding claim 17, Balboa as modified by Hamel discloses the cannula and inserter system of claim 16, but fails to explicitly disclose wherein the cannulated body further comprises a plurality of threads integrally formed therewith that correspond to a plurality of threads integrally formed with the central aperture of the third flange to enable the third flange to rotate about the cannulated body and move closer to the first flange or the second flange.
However, an alternative embodiment of Balboa is directed to a cannula (400) and teaches wherein the cannulated body further comprises a plurality of threads (407) integrally formed therewith that correspond to a plurality of threads integrally formed with the central aperture (a pawl of flange 410) of the third flange (410) to enable the third flange to rotate about the cannulated body and move closer to the first flange (420) (Figure 4A-B; Paragraph 0020).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Balboa by incorporating wherein the cannulated body further comprises a plurality of threads integrally formed therewith that correspond to a plurality of threads integrally formed with the central aperture of the third flange to enable the third flange to rotate about the cannulated body and move closer to the first flange or the second flange, as taught by an alternative embodiment of Balboa in order to allow for movement and fixed positioning of the flange along the length of the cannula (Paragraph 0020).
Regarding claim 18, Balboa further discloses wherein the elongated apertures of the third flange are configured to axially align with the second and third apertures of the second flange (Figure 2A; Paragraph 0017).
Regarding claim 19, the combination of the device of Balboa as modified by Hamel further teaches wherein the inserter is configured to be positioned within the elongated apertures of the third flange and the second and third apertures of the second flange while in use (the forceps of Hamel are inserted in holes 72 of flange 71, thus, Hamel teaches the claimed limitation (Paragraph 0087). Further, "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Balboa in view of Hamel as applied to claim 10, and further in view of Assia et al. (US 20160074054 A1).
Regarding claim 20, Balboa as modified by Hamel teaches the cannula and inserter system of claim 10, but fails to explicitly disclose wherein the inserter further comprises a stopper provided on at least one of the elongated flexible arms and having a first end and a second end, wherein a length from the second end of the stopper to the second end of the elongated flexible arm is substantially equivalent to a length between the first and second ends of the cannula.
However, Assia is directed to an inserter forceps (10) and teaches wherein the inserter further comprises a stopper (24) provided on at least one of the elongated flexible arms (12) and having a first end (upper surface of 24) and a second end (lower surface of 24) (Figure 1A; Paragraph 0029).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Balboa as modified by Hamel such that the inserter further comprises a stopper provided on at least one of the elongated flexible arms and having a first end and a second end, as taught by Assia, as both references and the claimed invention are directed to surgical devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Balboa as modified by Hamel with the teachings of Assia by incorporating wherein the inserter further comprises a stopper provided on at least one of the elongated flexible arms and having a first end and a second end in order to prevent over-squeezing of the forceps legs, preventing possible excessive force from being applied to the iris retractor assembly and preventing possible mechanical distortion (Assia Paragraph 0029). Further, Hamel is silent to the features of the disclosed forceps.
The combination of Balboa, Hamel, and Assia fails to explicitly disclose wherein a length from the second end of the stopper to the second end of the elongated flexible arm is substantially equivalent to a length between the first and second ends of the cannula.
However, there are a number of choices available to a person of ordinary skill in the art for the lengths between the second end of the stopper to the second end of the elongated flexible arm and a length between the first and second ends of the cannula. Either, a length from the second end of the stopper to the second end of the elongated flexible arm can be equal to a length between the first and second ends of the cannula, a length from the second end of the stopper to the second end of the elongated flexible arm can be less than a length between the first and second ends of the cannula, or a length from the second end of the stopper to the second end of the elongated flexible arm can be greater than a length between the first and second ends of the cannula. Therefore, “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under 103” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. __, 82 USPQ2d 1385 (2007).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DARWIN EREZO can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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