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.
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:
Distal stop mechanism in claims 1 and 5-13.
Proximal stop mechanism in claims 5, 9-12
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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bell (US Patent 5,465,731)
Regarding Claim 1, Bell teaches a tissue retrieval system comprising:
a tubular introducer (180; Figure 2) having a proximal end and a distal end and a lumen extending between the proximal end and the distal end (Figure 2);
an actuator (190) longitudinally slidable within the lumen of the introducer (180), the actuator (190) having a proximal end and a distal end (Figure 2);
a tissue retrieval bag (260; Figures 2-3); and
a handle assembly (110/120/105/130) at the proximal end of the introducer (180);
wherein in a redeployable configuration, the actuator (190) is repeatably longitudinally slidable between a proximal position (Figure 2) and a first deployed position (partial deployment) defined by the tissue retrieval bag being deployed from the distal end of the introducer and retained by the introducer (In this case the first deployed position the bag 260 would be partially deployed out of the introducer 180); and
wherein the handle assembly (110/120/105/130) comprises a distal stop mechanism (105; Figure 2) restricting distal movement of the actuator to the first deployed position (Column 6, Lines 6-14), the distal stop mechanism (105) being releasable (as it is withdrawn from slot 198) to selectively advance the actuator (190) from the first deployed position (partial deployment) to a second deployed position (fully deployed position as seen in Figure 1A) distal the first deployed position wherein in the second deployed position tissue retrieval bag is deployed from the introducer and released from the introducer (as seen in Figure 1A).
Claim(s) 14, 15 and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kahle (US PGPub 2007/0088370)
Regarding Claim 14, Kahle teaches a tissue retrieval system comprising:
a tubular introducer (3) having a proximal end and a distal end and a lumen extending between the proximal end and the distal end (Figure 1);
an actuator(7) longitudinally slidable within the lumen of the introducer, the actuator having a proximal end and a distal end (Figure 1); and
a tissue retrieval bag (21), the tissue retrieval bag comprising a bead (31) removably coupled to the distal end of the actuator (7) (Paragraph 0069 but also see Figure 7);
wherein in an initial configuration, the actuator (7) is repeatably longitudinally slidable between a proximal position with the tissue retrieval bag substantially withdrawn into the introducer (Figure 1) and a first deployed position (Figure 3) with the tissue retrieval bag deployed from the distal end of the introducer (3) and coupled to the actuator (7); and
wherein the bead (31) comprises a first bead portion and a second bead portion (both halves as seen in Figure 26; Paragraph 0073) securely coupled to the tissue retrieval bag such that the bead remains coupled to the tissue retrieval bag during repeated movement of the actuator from the proximal position to the first deployed position (as disclosed in Paragraph 0073 that the posts 77 capture the bag during folding of the bead).
Regarding Claim 15, Kahle teaches the tissue retrieval system of claim 14, wherein the first bead portion comprises a plurality of interference pins (77) and the second bead portion comprises a corresponding plurality of holes ultrasonically welded together with the interference pins (77). It is the Examiner’s position that the term “ultrasonically welded” is a product by process. Although the reference does not disclose “a plurality of holes ultrasonically welded with the pins”, it is noted that “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Furthermore, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP 2113.
Regarding Claim 18, Kahle teaches the tissue retrieval system of claim 14, wherein the first bead portion comprises a proximal bead section and the second bead portion comprises a distal bead section (34B; Figure 17) and wherein the distal bead section comprises an annular ledge (37c) configured to securely couple the tissue retrieval bag to the bead (Paragraph 0065).
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bell (US Patent 5,465,731) as applied to claim 1 above, and further in view of Holsten (US PGPub 2015/0289864).
Regarding Claim 4, Bell teaches the tissue retrieval system of claim 1, but fails to disclose wherein the distal stop mechanism comprises a cantilever beam formed in the actuator adjacent the proximal end of the actuator, the cantilever beam biased to interfere with the handle assembly with the actuator in the first deployed position and positionable to allow distal advancement of the actuator beyond the first deployed position.
Holsten teaches a specimen retrieval device having a tubular introducer (14; Figures 1-4), an actuator (16; Figures 1-4), a tissue retrieval bag (18; Figure 1), a handle assembly (12; Figures 1-2), wherein the handle has a distal stop mechanism (Figure 2), wherein the distal stop mechanism comprises a cantilever beam (24; Figure 2) formed in the actuator (16) adjacent the proximal end of the actuator (16; Figure 2), the cantilever beam (24) biased to interfere with the handle assembly (22; Figure 2; Paragraph 0105) with the actuator (16) in the first deployed position and positionable to allow distal advancement of the actuator (16) beyond the first deployed position (Paragraph 0105).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the distal stop mechanism of Bell, to include the teachings of Holsten, for the advantage of providing a mechanism to allow for distal stop mechanism to reset itself upon retraction of the actuator.
Claim(s) 5-7 and 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bell (US Patent 5,465,731) as applied to claim 1 above, and further in view of Kahle (US PGPub 2007/0088370)
Regarding Claim 5, Bell teaches the tissue retrieval system of claim 1, but fails to disclose wherein the handle assembly further comprises a proximal stop mechanism restricting proximal movement of the actuator in the redeployable configuration to the proximal position.
Kahle teaches a tissue retrieval device comprising an introducer (3; Figure 1), an actuator (7; Figure 1), a tissue retrieval bag (21; Figure 3), a handle assembly (5; Figures 1-3), and having a stop mechanism (Figures 10-12) for both distal and proximal movement of the actuator (Paragraph 0045-0048), and thus Kahle teaches the handle assembly further comprises a proximal stop mechanism (41/43 and 45) restricting proximal movement of the actuator in the redeployable configuration to the proximal position (Paragraph 0046).
It would have been obvious to one of ordinary skill in the art to modify the handle assembly of Bell to include a proximal stop mechanism as taught by Kahle, for the advantage of preventing inadvertent proximal movement of the actuator.
Regarding Claim 6, the combination of references disclosed above teaches the tissue retrieval system of claim 5, wherein Kahle teaches the handle assembly (5) comprises a bore formed therein (which houses ratchet teeth 45) and the proximal stop mechanism comprises an actuator post (41) positioned in the bore (as seen in Figure 10), wherein the actuator (7) comprises a surface having a ledge thereon (the ratchet teeth 45), the ledge (ratetchet teeth; 45 in Figure 10) engageable with the actuator post (41) to prevent proximal movement of the actuator from the proximal position (Paragraph 0046).
Regarding Claim 7, the combination of references disclosed above teaches the tissue retrieval system of claim 6, wherein Kahle teaches advancement of the actuator to the second deployed position compresses the actuator post (via leaf spring 43) into a non-protruding position (as it slides along the teeth) to release the proximal stop mechanism such that the actuator (7) is movable proximally from the second deployed position to a position proximal the proximal position (Figure 10; Paragraph 0045).
Regarding Claim 9, Bell teaches the tissue retrieval system of claim 1, but fails to disclose wherein the handle assembly further comprises a pawl assembly restricting proximal movement of the actuator in the redeployable configuration to the proximal position and preventing longitudinal distal advancement of the actuator once the actuator has been withdrawn proximally from the second deployed position to a position proximal the proximal position.
Kahle teaches a tissue retrieval device comprising an introducer (3; Figure 1), an actuator (7; Figure 1), a tissue retrieval bag (21; Figure 3), a handle assembly (5; Figures 1-3) comprising a pawl assembly (41/43; Figure 10) restricting proximal movement of the actuator (7) in the redeployable configuration to the proximal position and preventing longitudinal distal advancement of the actuator (7) once the actuator (7) has been withdrawn proximally from the second deployed position to a position proximal the proximal position (See Figures 10-12 and Paragraph 0047).
It would have been obvious to one of ordinary skill in the art to modify the handle assembly of Bell to include a pawl assembly as taught by Kahle, for the advantage of preventing inadvertent movement of the actuator during deployment.
Regarding Claim 10, the combination of references disclosed above teaches the tissue retrieval system of claim 9, wherein Kahle teaches the actuator (7) comprises a longitudinally extending rib having a first recess formed therein (ratchet 45; Figures 10-12), the first recess having a distal wall, and wherein the pawl assembly comprises a pawl pivotally coupled to the handle assembly and a pawl spring (43) biasing the pawl to a centered position (as seen in Figure 11).
Regarding Claim 11, the combination of references disclosed above teaches the tissue retrieval system of claim 10, wherein in the redeployable configuration, the pawl (41) is slidable along the longitudinally extending rib (45; Figure 10) and engageable with the distal wall of the first recess to prevent proximal movement of the actuator beyond the proximal position (as seen in Figure 10).
Allowable Subject Matter
Claims 2-3, 8, 12, 13, 16, 17, and 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art fails to disclose:
Claim 2: the tissue retrieval system of claim 1, wherein the distal stop mechanism comprises a groove extending along a portion of the actuator, the groove having a proximal end wall and a deployment release button positioned in the handle assembly, the deployment release button comprising a latch tab positioned to slidingly engage the groove and to interfere with the proximal end wall of the groove with the actuator in the first deployed position.
Claim 3: the tissue retrieval system of claim 2, wherein the deployment release button is positionable in a release position in which the latch tab is positioned out of alignment with the proximal end wall of the groove such that the actuator is longitudinally advanceable distal of the first deployed position.
Claim 8: the tissue retrieval system of claim 7, wherein the actuator comprises a camming ramp formed therein adjacent the proximal end thereof, the camming ramp positioned to compress the actuator post to a disengaged position relative to the actuator when the actuator is distally advanced to the second deployed position.
Claim 12: the tissue retrieval system of claim 10, wherein the longitudinally extending rib comprises a second recess formed therein distal the first recess, the second recess having a proximal wall, and wherein once the actuator has been withdrawn proximally from the second deployed position to a position proximal the proximal position, the pawl is positioned in the second recess and engages the proximal wall to prevent longitudinally distal movement of the actuator.
Claim 13: the tissue retrieval system of claim 12, wherein the longitudinally extending rib has a proximal end and with the actuator advanced distally to the second deployed position, the pawl is positioned out of engagement with the longitudinally extending rib beyond the proximal end of the longitudinally extending rib.
Claim 16: the tissue retrieval system of claim 15, wherein the tissue retrieval bag comprises a belt (extended cuff as described in Paragraph 0065 and wherein one of the first bead portion and the second bead portion comprises a post (77) engaged with the belt (Paragraph 0065 and Figure 26).
Claim 17: the tissue retrieval system of claim 14, wherein the tissue retrieval bag comprises a hole formed therein and wherein one of the first bead portion and the second bead portion comprises a post sized and configured to mate with the hole of the tissue retrieval bag to securely couple the bead to the tissue retrieval bag.
Claim 19: the tissue retrieval system of claim 14, wherein the first bead portion and the second bead portion are substantially identical, and wherein the first bead portion and the second bead portion each comprise a first energy director for ultrasonically welding the first bead portion to the second bead portion and wherein the first bead portion and the second bead portion each comprise a plurality of second energy directors to ultrasonically weld the first bead portion and the second bead portion to the tissue retrieval bag.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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