DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a fluid rate mechanism” in claims 2 and 14.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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 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) 1-4 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stieglitz et al. (2013/0303979).
With respect to claim 1, Stieglitz discloses a suction instrument, as shown in figure 1, comprising an elongate cannula 5 comprising a proximal portion and a distal portion, the elongate cannula defining a suction lumen in fluid communication with the distal portion, as shown in figure 2, and the distal portion configured to be positioned within or adjacent an anatomical passageway of a patient, as disclosed in paragraph [0059]. A handle assembly 6 is associated with the proximal portion of the cannula 5, as shown in figure 5a, and comprises a deformable grasping body defining a fluid communication chamber 8, as shown in figure 5a, wherein the grasping body is configured to elastically deform between a relaxed state and a compressed state, as shown in figure 5c, to alter fluid communication between the fluid communication chamber and suction lumen, as disclosed in paragraph [0022].
With respect to claim 2, a fluid rate mechanism 19 is configured to assist the deformable grasping body 6 in altering fluid communication, as shown in figure 1.
With respect to claim 3, fluid communication between the fluid communication chamber and the lumen is a first amount while in the relaxed state and a second amount in the compressed state, the first amount being greater than the second amount, as shown in figures 3a and 3b.
With respect to claim 4, fluid communication between the fluid communication chamber and the lumen is a first amount while in the relaxed state and a second amount in the compressed state, the first amount being less than the second amount, as shown in figures 4a and 4b.
With respect to claim 8, the cannula 5 comprises an intermediate bend between the proximal and distal portions, as shown in figure 1.
Claim(s) 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Govari et al. (2022/0193322).
With respect to claim 10, Govari discloses a suction instrument, as shown in figure 1, comprising an elongate cannula 16 comprising a proximal portion and a distal portion wherein the distal portion is configured to be positioned within or adjacent an anatomical passageway of a patient. The cannula 16 defines a suction lumen, as disclosed in paragraph [0041]. A handle assembly comprises a grasping body 12 comprising an open proximal end, as shown in figure 2B, defining a fluid communication chamber 47 in fluid communication with the suction lumen of the cannula 16, as shown in figure 1. A removable fluid coupling body 50 is removably coupled with the grasping body 12 between an attached configuration, as shown in figure 2A, and a detached configuration, as shown in figure 2B. In the attached configuration, the fluid coupling body 50 couples the grasping body 12 with a suction source 24, as shown in figure 1. In the detached configuration, the fluid coupling body 50 is removed to expose the fluid communication chamber 47 at the open proximal end of the grasping body 12, as shown in figure 2B.
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.
Claim(s) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stieglitz et al. (2013/0303979) in view of Govari et al. (2022/0193322).
With respect to claim 5, Stieglitz discloses all aspects of the claimed invention with the exception of a removable fluid coupling body. Govari discloses a suction instrument, as shown in figure 1, comprising an elongate cannula 16, a handle assembly comprising a grasping body 12, and a removable fluid coupling body 50 configured to selectively attach to the grasping body, as shown in figure 2B. Govari teaches that a removable fluid coupling body allows for separate cleaning, as disclosed in paragraph [0037]. It would therefore have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the suction instrument of Stieglitz with a removable fluid coupling body, as taught by Govari, to achieve the predictable result of allowing for easier cleaning and sterilization.
With respect to claim 6, modified Stieglitz discloses all aspects of the claimed invention with the exception of a bayonet fitting. Bayonet fittings are well known in the art to provide an easy to use attachment between two elements of a medical device. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the grasping body and fluid coupling body of modified Stieglitz with a bayonet fitting to achieve the predictable result of an easy to use attachment.
With respect to claim 7, modified Stieglitz discloses all aspects of the claimed invention with the exception of a fluid tight seal between the fluid coupling body and the grasping body. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide a fluid tight seal between the fluid coupling body and the grasping body of modified Stieglitz to achieve the predictable result of preventing leakage of fluid during use of the instrument.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stieglitz et al. (2013/0303979) in view of Rodriguez et al. (2018/0214217).
With respect to claim 9, Stieglitz discloses all aspects of the claimed invention with the exception of the cannula being formed of a rigid material. Rodriguez discloses a suction instrument comprising an elongate cannula 212, as shown in figure 6, and teaches that forming the cannula from a rigid material provides for maintaining the bend in the cannula and prevents buckling of the cannula during use, as disclosed in paragraph [0076]. It would therefore have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to form the cannula of Stieglitz from a rigid material, as taught by Rodriguez, to maintain the bend in the cannula and prevent buckling of the cannula during use.
Claim(s) 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (2022/0193322) in view of Stieglitz et al. (2013/0303979).
With respect to claims 11-14, Govari discloses all aspects of the claimed invention with the exception of the grasping body defining a suction control opening and being formed of a resiliently deformable material that is configured to deform to alter an amount of fluid communication, and a fluid rate mechanism. Stieglitz discloses a suction instrument, as shown in figure 1, comprising a grasping body comprising a suction control opening 19 and being formed of a resiliently deformable material, as disclosed in paragraph [0015], and a fluid rate mechanism 15-18, as shown in figure 2. Stieglitz teaches that forming the grasping body from a resiliently deformable material and providing the suction control opening and fluid rate mechanism allow a user to easily switch between irrigation and suction using only one hand, as disclosed in paragraph [0013]. It would therefore have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to form the grasping body of Govari from a resiliently deformable material and to provide a suction control opening and a fluid rate mechanism, as taught by Stieglitz, to allow a user to easily switch between irrigation and suction using only one hand.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (2022/0193322).
With respect to claims 15-16, Govari discloses all aspects of the claimed invention with the exception of a bayonet fitting. Bayonet fittings are well known in the art to provide an easy to use attachment between two elements of a medical device. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the grasping body and fluid coupling body of modified Govari with a bayonet fitting to achieve the predictable result of an easy to use attachment.
Allowable Subject Matter
Claim 17-20 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record does not disclose the claimed invention, a suction instrument having a shaft assembly comprising an elongate cannula, a proximal attachment body, and a navigation assembly comprising a navigation sensor, programmable memory unit comprising a navigation sensor profile, and a first connector. The closest prior art of record, made herein of record but not relied upon for any rejection, U.S. Patent 12,691,211 to Omar, discloses a suction instrument, as shown in figure 1, comprising an elongate cannula 220 and a proximal attachment body 210. The shaft assembly further comprises a navigation sensor, as disclosed in column 3, lines 17-22. However, Omar discloses that the programmable memory unit 336 is separate from the shaft assembly 210, as shown in figures 3 and 4. The prior art of record therefore does not disclose nor fairly suggest the claimed invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patents 4,342,315 and 5,300,043 disclose suction instruments having resiliently deformable controls. U.S. Patent 12,691,211 discloses a suction instrument having a navigation assembly.
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/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781
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