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 .
Response to Amendment
This Office Action is a response to applicant’s arguments and amendment filed 08/03/2026. Claims 1 and 7-8 are amended. Claims 2 and 6 are cancelled. Claims 1, 3-5 and 7-10 are currently pending.
The objection of claim 8 has been withdrawn due to applicant’s amendment.
Response to Arguments
Applicant’s arguments, see Remarks, filed 08/03/2026, with respect to the rejection(s) of claim(s) 1-2 and 4-7 under 35 U.S.C. 102(a)(1) as being anticipated by Perez; claim 3 under 35 U.S.C. 103 as being unpatentable over Perez in view of Rydell; claim 8 under 35 U.S.C. 103 as being unpatentable over Perez in view of West, Jr., and claims 9-10 under 35 U.S.C. 103 as being unpatentable over Perez in view of Guan, have been fully considered but are not persuasive, in combination with the amendments to the claims. The rejection has been modified, necessitated by applicant’s amendment to the claims.
1) Applicant argues Perez is directed to a completely different application than the debridement device of claim 1, because Perez discloses a surgical tool for hard bones and not for debridement of fragile soft tissue, such that Perez is limited to high-speed bone grinding drill bits (Remarks, pgs. 5-6).
In response to applicant’s first argument, it is respectfully submitted the arguments are narrower than the claim limitations. Claim 1 recites a debridement device for human diseased tissue in the preamble, and does not limit the tissue to a specific type of tissue, or limit the device to operating at a specific speed. Further, the preamble recites intended use which does not result in a structural difference between the claimed invention and the prior art (see MPEP 2111.02(II)). As discussed below, Perez incorporates Kablik by reference, describing the field of invention as a device for debridement of tissue, such that the claimed limitation is considered to be met.
2) Applicant further argues the interior of bearing sleeve 34 does not communicate with passageway 25, the opening of the bearing sleeve 34 is formed at the distal end rather than the side of bearing sleeve 34, and the distal end of the bearing sleeve 34 is flat rather than curved (Remarks, pgs. 6-7).
In response to applicant’s second argument, it is respectfully submitted the interior of bearing sleeve 34 is considered to communicate with hollow interior 23 because bearing sleeve 34 includes a lumen that surrounds passageway 25 which communicates with interior 23 (i.e. the lumen of sleeve 34 is considered to be in communication with interior 23 via being in contact with and surrounding passageway 25). Further, the claim language of the opening being formed “in a side of the housing” does not preclude an interpretation of the distal side of the housing from being applied. Under broadest reasonable interpretation, a side encompasses a distal side of the structure. Lastly, as discussed below, the bearing sleeve 34 is considered to be tubular and therefore encompasses an arc or curve shape as part of the tubular component, such that a top of bearing sleeve 34 is considered to include arced components within the tubular structure of the sleeve.
3) Applicant further argues grooves 13 only form one passageway between the outer member 11 and inner component 22 as opposed to two irrigation channels independent of each other (Remarks, pgs. 7-8).
In response to applicant’s third argument, it is respectfully submitted the channels are considered to be formed by grooves 13 as depicted in fig. 6 of Perez. Gaps are formed at grooves 13 in distinct locations surrounding sleeve 34, which are considered to constitute channels at least at that location within the device. The arguments are narrower than the claim language, because the claim language does not recite the first and second irrigation channels being independent and not in communication with each other along their entire length or extent. As discussed below, the grooves 13 divide the irrigation lumen into multiple channels, such that the claim limitation is considered to be met. Accordingly, the claims remain rejected.
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: “driving component” in claim 5; “fixing structure for fixing” in claim 10.
Para. [0037] of the instant spec. describes the “driving component” as a motor. “Driving component” uses the generic placeholder “component” coupled with the term “driving”, which is functional in that the limitation alternatively recites a component for driving, and the term “component” is not preceded by a structural modifier since the term “driving” does not imply any structure.
Paras. [0045]-[0046] of the instant spec. describe the “structure for fixing” as a buckle or magnetic attraction structure. “Structure for fixing” uses the generic placeholder “structure” coupled with the term “fixing”, which is functional, and the term “structure” is not preceded by a structural modifier since the term “fixing” does not imply any structure.
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, 4-5, and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Perez (US 6132448) (all references previously of record).
Regarding claim 1, Perez discloses (see abstract; col. 2 line 22-col. 4 line 21; figs. 1-8) a debridement device for human diseased tissue (see col. 1 lines 9-12 describing the field of the invention as relating to the system disclosed in US 5792167 to Kablik, which describes the device used for removal of debris from a surgical site, such that Perez is considered to disclose the device for debridement/removal of tissue, abstract of Kablik, col. 1 lines 9-12 of Perez), comprising an insertion tube (includes outer member 11 and inner member 22, col. 2 lines 23-67; fig. 2), a rotary cutting head (includes bearing sleeve 34 and cutting tool 24, col. 3 lines 1-12; fig. 5) and an operating handle (39, col. 3 lines 25-58; fig. 8), wherein the insertion tube comprises an inner tube (22) and an outer tube (11) sleeved outside the inner tube (fig. 2), a dirt suction chamber (23, col. 4 lines 1-12) is formed in the inner tube (fig. 2), and an irrigation chamber (29, col. 3 lines 25-58) is formed between the inner tube and the outer tube (fig. 5); the rotary cutting head comprises a housing (34) and a rotary cutter head (24) arranged in the housing (fig. 5); an interior of the housing communicates with the dirt suction chamber (via lumen of 22), a rotary cutting opening (distal end of sleeve 34) for exposing the rotary cutter head is formed in the housing (fig. 5), and a notch (distal end of outer member 11) corresponding to the rotary cutting opening (considered to correspond since both openings are at distal end) is formed in the outer tube (fig. 5); the operating handle is connected with the insertion tube and the rotary cutting head (fig. 8) to control the rotary cutter head to cut human tissue at the rotary cutting opening (considered to cut tissue at distal end), to suck dirt from the dirt suction chamber, and to irrigate the rotary cutting head through the irrigation chamber (col. 4 lines 1-12 and claim 5); wherein the rotary cutting opening is formed in a side of the housing (distal end of sleeve 34 considered to be a distal side of sleeve 34, which has an opening at its distal end, fig. 5), and a top of the housing is a blind end (considered to be a blind end by being covered by an additional structure, which appears consistent with the instant spec.) and is arc-shaped (considered to be arc-shaped since sleeve 34 is tubular, therefore encompassing a shape of an arc, fig. 5); wherein partitions (13, figs. 6-7) are arranged between the inner tube and the outer tube (figs. 6-7) to divide the irrigation chamber into a first irrigation channel and a second irrigation channel (grooves considered to form channels); an opening of one end, away from the operating handle, of the first irrigation channel is formed in one end, adjacent to the insertion tube, of the rotary cutting head (depicted in fig. 7), and is located on the housing at a position where the rotary cutting opening is located on the housing (figs. 6-7, see sleeve 34); one end, away from the operating handle, of the outer tube is not closed with respect to the housing (fig. 7), and the second irrigation channel is formed between the outer tube and a side wall of the housing at the rotary cutting head (fig. 7); and an opening of the second irrigation channel is formed in an end portion of one end, away from the operating handle, of the housing (depicted in fig. 7).
Regarding claim 4, Perez discloses the debridement device for human diseased tissue according to claim 1. Perez further discloses wherein the rotary cutter head is rotatably arranged in the housing about an axis of the rotary cutter head (rotatably driven, abstract; fig. 5).
Regarding claim 5, Perez discloses the debridement device for human diseased tissue according to claim 4. Perez further discloses wherein the rotary cutting head comprises a rotating shaft (37), one end of the rotating shaft is connected with the rotary cutter head (via 11), and an other end of the rotating shaft is connected with a driving component (motor, col. 3 lines 25-58) in the operating handle, and the driving component drives the rotary cutter head to rotate through the rotating shaft (abstract, col. 3 lines 25-58).
Regarding claim 7, Perez discloses the debridement device for human diseased tissue according to claim 1. Perez further discloses wherein two end portions of the outer tube are respectively flush with end portions of the housing where the rotary cutting opening is not provided (see figs. 5-7, considered to be flush in that outer member 11 surrounds sleeve 34, which appears consistent with the instant spec.).
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) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Perez in view of Rydell (US 5810809).
Regarding claim 3, Perez discloses the debridement device for human diseased tissue according to claim 1.
Perez further discloses wherein the operating handle is provided with a negative pressure suction port (passageway 42, col. 4 lines 1-12; fig. 8); one end, away from the rotary cutting head, of the dirt suction chamber communicates with the negative pressure suction port (proximal end of 23).
However, Perez fails to disclose a suction bottle and an aspirator form a negative pressure in the dirt suction chamber through the negative pressure suction port. Perez is instead silent to the specific source of suction provided to passageway 42.
Rydell teaches (col. 3 lines 32-60 and col. 5 lines 32-54; fig. 1), in the same field of endeavor, a debridement device (abstract) comprising a suction bottle (28) and an aspirator (source of vacuum) forming a negative pressure within the device (applies vacuum to inner tubular cutter member 24), for the purpose of effectively macerating tissue and sucking the tissue back through the lumen of the inner tubular member and the lumen of the handle to a collection canister (col. 5 lines 32-54).
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 suction source of Perez to be comprised of a suction bottle and an aspirator forming the negative pressure through the suction port, in order to effectively macerate tissue and suck the tissue back through the lumen of the inner member and the lumen of the handle to a collection canister, based on the teachings of Rydell (col. 5 lines 32-54).
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Perez in view of West, Jr. (US 6610059 B1).
Regarding claim 8, Perez discloses the debridement device for human diseased tissue according to claim 1.
However, Perez fails to disclose wherein the inner tube is provided with a plurality of connecting holes for communicating the dirt suction chamber with the irrigation chamber, and a flow direction control structure is arranged at the plurality of connecting holes to allow one-way flow of an irrigation solution from the irrigation chamber into the dirt suction chamber.
West, Jr. teaches (col. 8 lines 52-67; figs. 3-4), in the same field of endeavor, a debridement device (figs. 3-4) comprising an inner tube (38) provided with a plurality of connecting holes (36) for communicating an aspiration chamber with an irrigation chamber (depicted in figs. 3-4), and a flow direction control structure (ring of holes) is arranged at the connecting holes (figs. 3-4) to allow one-way flow of an irrigation solution from the irrigation chamber into the aspiration chamber (see direction of flow in figs. 3-4, depicted as one-way flow), for the purpose of providing a continuous pathway for the aspiration of gaseous bubble (col. 9 lines 39-50).
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 inner member 22 of Perez to include a plurality of holes, in order to provide a continuous pathway between the irrigation grooves in the outer tube and the lumen of the inner member, providing the capability of pulling irrigation liquid into lumen 23 at various locations along the inner member when desired, based on the suggestions and teachings of West, Jr. (col. 9 lines 39-50).
Claim(s) 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Perez in view of Guan (US 2024/0390647 A1).
Regarding claim 9, Perez discloses the debridement device for human diseased tissue according to claim 1.
However, Perez fails to disclose wherein the insertion tube is provided with a bent part and a guide wire connected with the bent part, the bent part is arranged at a position, adjacent to the rotary cutting head, of the insertion tube, the bent part is connected with a guide wire control structure on the operating handle through the guide wire, and a length of the guide wire is controlled through the operating handle to control a degree of bending of the bent part.
Guan teaches (paras. [0038]-[0070]; figs. 1-20), in the analogous art of the claimed invention, a deflectable catheter provided with a bent part (11, para. [0038]) and a guide wire (includes traction wires 21 and 22) connected with the bent part (fig. 1), the bent part is connected with a guide wire control structure (driving mechanism 30) on the operating handle through the guide wire (fig. 2), and a length of the guide wire is controlled through the operating handle to control a degree of bending of the bent part (para. [0038]), for the purpose of reaching complex lesion sites, so the frequency of catheter adjustments and replacements by clinical operators can be greatly reduced, thus facilitating the operation and reducing the risk of complications (para. [0039]).
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 insertion tube of Perez to include a bent part connected to a guide wire as claimed, in order to provide the capability of reaching complex lesion sites, so the frequency of device adjustments and replacements by clinical operators can be greatly reduced, thus facilitating the operation and reducing the risk of complications, based on the suggestions and teachings of Guan (para. [0039]).
Perez (as modified) further teaches the bent part is arranged at a position, adjacent to the rotary cutting head, of the insertion tube (combination considered to further teach bend located adjacent to cutting member 24, see figs. 1-2 of Guan).
Regarding claim 10, Perez (as modified) teaches the debridement device for human diseased tissue according to claim 9. Perez (as modified) further teaches wherein the guide wire control structure comprises a rotating gear (para. [0046]), the guide wire is wound on the rotating gear (para. [0047]), and a fixing structure for fixing (70, considered to correspond to the structure disclosed for the fixing structure interpreted under 112(f), para. [0061]) a rotating angle of the rotating gear is arranged on the rotating gear (paras. [0059]-[0061]; figs. 15-17).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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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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/BRIGID K BYRD/Examiner, Art Unit 3771
