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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 06/29/2026 is acknowledged.
Claims 22-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim.
Claim Objections
Claims 8, 15 are objected to because of the following informalities:
In line 1 of claim 8, “the cavity” should be changed to “the internal cavity” in order to maintain consistent terminology.
In line 1 of claim 15, “depth limited” should be changed to “depth limiter”.
In lines 1-2 of claim 21, “the trocar housing” should be changed to “a trocar housing” or should be amended to depend from claim 20 to provide proper antecedent basis for the limitation.
Appropriate correction is required.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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: “locking mechanism” in claims 1, 12, and 13.
The specification of the present invention defines the structure configured for performing the function of locking is pressure element designed to apply mechanical pressure for setting the trocar cannula in the fixed position by friction, a lever connected to a C shaped pin, the C shaped pin designed to engage the trocar cannula and apply mechanism pressure to the trocar cannula in response to a pressure applied to the lever, or a movable protruding element designed to engage an indentation of the trocar cannula (page 1 lines 18-32).
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, 2, 5-8, 12-15 and 20-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pacak et al. (US 2014/0257356).
Regarding claim 1, Pacak et al. discloses a kit for minimally invasive surgery (FIG 4), comprising: a trocar cannula (11, FIG 4, [0048-0049]); and a depth limiter component (10, FIG 1, [0048-0054]) comprising: a lumen sized (See lumen in FIGs 1-3) and shaped to accommodate a trocar cannula (FIG 4-9 show the trocar cannula 11 being received within the lumen of 10), wherein an external diameter of the trocar cannula is sized to correspond to an internal diameter of the lumen (By the trocar being small enough to pass through the lumen, it is interpreted as being “sized to correspond to” the lumen diameter), a locking mechanism (14A and 14B, which locks around the trocar [0049-0050, 0054]. This collar/lever structure is interpreted as a structural equivalent of a locking mechanism as set forth above) that sets the trocar cannula in a fixed position within the lumen ([0049] “The abutment member forms a collar 14A surrounding the sleeve with a manually operable over-center clamp 14B for releasable connection to the sleeve 11 so as to be adjustable longitudinally of the trocar sleeve 11 so as to be located at a selected position 11A as shown in FIG. 4”), a housing that includes the lumen and the locking mechanism (The structural body of 14 is interpreted as the housing which includes the lumen and locking mechanism), and at least one aperture of the housing (See annotated FIG 1 below) in fluid communication between an internal cavity of the housing (See annotation, the internal cavity is interpreted as the cavity within the body of 14 which receives the anchoring portion of 14B inserted therein) and an external environment external to the housing (The FIG 1 below shows the aperture creases a fluid communication between the cavity and the external environment).
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Regarding claim 2, Pacak et al. discloses the locking mechanism comprises a pressure element (The annular body of collar 14A is interpreted as the pressure element) designed to apply mechanical pressure for setting the trocar cannula in the fixed position by friction ([0049]; when manually operable over-center clamp 14B is actuated, collar 14A surrounds the trocar cannular and frictionally engages to secure the position).
Regarding claim 5, Pacak et al. discloses the depth limiter further includes a distal surface that is substantially flat and smooth (See annotated FIG 4 below), for contacting skin of a subject (13) surrounding an entry point of the trocar cannula (FIG 4).
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Regarding claim 6, Pacak et al. discloses the depth limiter further includes a tapered outer surface (See annotated FIG 4 above) that is substantially smooth, that tapers outwards from an edge of a distal surface (FIG 4).
Regarding claim 7, Pacak et al. discloses the depth limiter further comprises a smooth round surface for connecting between an edge of the distal surface and the tapered outer surface (At least some portion of the curved edge between the tapered surface and the distal surface is interpreted as the smooth round surface).
Regarding claim 8, Pacak et al. discloses the cavity of the housing is located in a thickness between the lumen and an external lateral surface (See annotated FIG 1 above wherein the cavity is positioned in a space of the housing between the lumen and an external lateral surface).
Regarding claim 12, Pacak et al. discloses moving components of the locking mechanism (i.e. manually operable over-center clamp 14B) are disposed within the internal cavity of the housing (The pivoting hinge of 14B is received within the internal cavity as described above) and in fluid communication with the external environment (14B extends form the internal cavity to the external environment and therefore is interpreted as being in fluid communication with the external environment).
Regarding claim 13, Pacak et al. discloses the locking mechanism is reversible, for releasing the trocar cannula from the fixed position, for at least one of: removal of the trocar cannula from the lumen, and insertion of the trocar cannula further into the lumen ([0049] “The abutment member forms a collar 14A surrounding the sleeve with a manually operable over-center clamp 14B for releasable connection to the sleeve 11 so as to be adjustable longitudinally of the trocar sleeve 11 so as to be located at a selected position 11A as shown in FIG. 4”. The trocar can be further inserted or removed from the lumen upon reversible operation of 14B of the locking mechanism).
Regarding claim 14, Pacak et al. discloses dimensions of the depth limiter are selected for maintaining a trocar cannula in a substantially upright position that is approximately perpendicular to skin of a subject (FIG 4 shows trocar cannula 11 being held substantially perpendicular to skin 13), while the trocar cannula is fixed in position in the depth limiter, and when the trocar cannula is not being supported by an external entity (This position is held when the locking mechanism is set to fix the position as described in [0049] and when the trocar is not being supported by an external entity such as the hand of the operator).
Regarding claim 15, Pacak et al. discloses the dimensions of the depth limited are selected for maintaining an instrument in the substantially upright position that is approximately perpendicular to skin of the subject (FIG 4 shows an instrument such as trocar cannula 11 being held substantially perpendicular to skin 13), when the instrument is inserted through the trocar cannula piercing the skin into the body of the subject, and when the instrument is not being supported by the external entity (This position is held when the locking mechanism is set to fix the position as described in [0049] and when the trocar is not being supported by an external entity such as the hand of the operator).
Regarding claim 20, Pacak et al. discloses further comprising a trocar sleeve (12) that includes a trocar housing (Tip portion shown in FIG 5 is interpreted as the trocar housing) and the trocar cannula (11).
Regarding claim 21, Pacak et al. discloses a sealing element (15, [0054, 0056]) designed to engage the trocar housing (Wherein tip portion shown in FIG 5 is interpreted as the trocar housing and 15 engages as shown in FIG 7-9).
Claim(s) 1, 4, 9-11, and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vijayachandran (US 2021/0338282).
Regarding claim 1, Vijayachandran discloses a kit for minimally invasive surgery (FIG 6), comprising: a trocar cannula (120, FIG 6, [0052]); and a depth limiter component (200, FIG 6-8C, [0059]) comprising: a lumen (224, FIG 8A-8C, [0063]) sized and shaped to accommodate a trocar cannula (FIG 8B-8C, [0067]), wherein an external diameter of the trocar cannula is sized to correspond to an internal diameter of the lumen (By the trocar being small enough to pass through the lumen, it is interpreted as being “sized to correspond to” the lumen diameter, [0064]), a locking mechanism (Ridges on at least one of lobes 220 which frictionally engage the ribs 128 on the outer surface of the cannula, [0065]. This protrusion/indentation structure is interpreted as a structural equivalent of a locking mechanism as set forth above) that sets the trocar cannula in a fixed position within the lumen ([0065]), a housing that includes the lumen and the locking mechanism (The structural body of 206 is interpreted as the housing which includes the lumen and locking mechanism, [0061, 0063], FIG 7), and at least one aperture of the housing (The opening to one bore 212, FIG 7) in fluid communication between an internal cavity of the housing (The lumen space of bore 212 is interpreted as an internal cavity of the housing) and an external environment external to the housing (The opening to one of bore 212 at the top of housing 206 is exposed to the external environment, FIG 7).
Regarding claim 4, Vijayachandran discloses the locking mechanism comprises a movable protruding element (One lobe 220 having ridges is interpreted as the movable protruding element) designed to engage an indentation of the trocar cannula (Wherein ribs 128 is the indentation, [0065-0067]).
Regarding claim 9, Vijayachandran discloses the at least one aperture of the housing comprises at least one first aperture located on a distal surface of the housing and at least one second aperture located on a proximal surface of the housing (Since bore 212 passing completely through the housing, FIGs 8A-8B, there is an aperture located at the distal surface of the housing and the proximal surface of the housing, both apertures defining entry points into the bore 212).
Regarding claim 10, Vijayachandran discloses at least one of the first aperture and the second aperture are arc-shaped (See arc shaped cross section in FIGs 8A-8C).
Regarding claim 11, Vijayachandran discloses the housing comprises at least one third aperture located along a surface of the housing forming the lumen (Such as a top aperture of an adjacent bore 212), the at least one third aperture in fluid communication with the at least one aperture of the housing (by both being exposed to the external environment on a top side of the housing, the third and first apertures of the housing are in fluid communication).
Regarding claim 16, Vijayachandran discloses the depth limiter component is made from a biocompatible material that is resistant to autoclaving, designed for multi-use ([0060] discloses 200 “may be formed of surgical steel or other material suitable to render depth limiter sterilizable and reusable for multiple surgical procedures”).
Regarding claim 17, Vijayachandran discloses the lumen includes a first guide element (Ridges on another lobe 220, [0065]) set for engaging a corresponding second guide element of the trocar cannula (Another at least one of the ribs 128), wherein the trocar cannula is insertable into the lumen by engaging the first guide element with the second element (When the trocar is received within the lumen, the ridges engage the ribs ,[0065]), and the trocar cannula is prevented from being inserted into the lumen when the first guide element does not engage the second guide element (If the ridges are not in contact with the ribs, it indicates that the trocar is not inserted into the lumen).
Regarding claim 18, Vijayachandran discloses the first guide element engaging the second guide element prevent rotation of the trocar cannula within the depth limiter (The frictional engagement between the first and second guide element is sufficient to prevent axial movement until a threshold force is applied, and therefore is understood to also at least partially prevent rotation until a threshold force is applied).
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) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Pacak et al. (US 2014/0257356) in view of Peartree et al. (US 2004/0138702).
Regarding claim 3, Pacak et al. discloses the invention substantially as claimed, a set forth above for claim 2. Pacak et al. further discloses the locking mechanism comprises a lever (14B, [0046], FIG 1) but is silent regarding the lever being connected to a C shaped pin, the C shaped pin designed to engage the trocar cannula and apply mechanism pressure to the trocar cannula in response to a pressure applied to the lever.
However, Peartree et al. teaches a locking mechanism (20, FIG 2 and 4-5, [0027-0028]) for clamping around a trocar cannula (26), the locking mechanism comprising a lever (50) connected to a C shaped pin (16, FIG 4-5, [0028]), the C shaped pin designed to engage the trocar cannula and apply mechanism pressure to the trocar cannula in response to a pressure applied to the lever (As shown in the locked state of FIG 5, [0028]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the locking mechanism of Pacak to further comprise a C shaped pin connected to the lever and designed to engage the trocar cannula and apply mechanism pressure to the trocar cannula in response to a pressure applied to the lever, as taught by Peartree et al., for the purpose of providing a structure for engaging the surface of the cannula to frictionally engage thereon upon actuation of the lever to achieve the predictable result of performing the locking function.
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Pacak et al. (US 2014/0257356).
Regarding claim 19, Pacak et al. discloses the invention substantially as claimed, a set forth above for claim 1.
Pacak is silent regarding a plurality of depth limiters having lumens with a plurality of different diameters for accommodating trocar cannulas with different diameters.
However, it would have been obvious to one of ordinary skill in the art at the time of filing to provide at least one additional depth limiter having a lumen with a different diameter, for the purpose of providing the surgeon with the option to select the depth limiter most suitable for use with a particular trocar cannula size. Mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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