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
In light of Applicant’s amendment, claim(s) 1, 6, 8-9, and 19-20 is/are amended. Claim 3-5 and 7 were previously canceled. Claims 1-2, 6, 8-12, and 19-20 are now pending examination.
The objections to the claims are withdrawn in light of Applicant’s amendment.
The rejection(s) under 35 U.S.C. 112(b) to claim(s) 1-2, 6, and 8-12 is/are withdrawn in light of Applicant’s amendment.
Response to Arguments
Applicant’s arguments, filed 8/13/2025, with respect to the rejection(s) of claim(s) 1 under U.S.C. 103 have been fully considered and are persuasive. Examiner agrees the added limitations requiring “a chamber positioned immediately proximal to and enclosing the crown reamer, the chamber having a laterally-opening slot: wherein the laterally-opened slot is radially open and dimensioned smaller than the drain diameter so the slot can capture only the first suture first and wherein the slot is configured to first direct the suture and subsequently second direct the distal end of the surgical drain into the chamber so that the suture is disposed between the crown reamer and the surgical drain: where the slot is configured to position the suture between the reamer and the drain and the opposing blunt/sharp edges prevent cutting the drain while rotating in alternating directions; wherein the crown reamer and the plurality of teeth are oriented such that rotation of the device in a first rotational direction advances only the blunt edges into patient tissue without cutting, and rotation of the device in a second, opposite to the first, rotational direction advances only the sharp edges to cut the suture while avoiding contact with the surgical drain: wherein an inner surface of the hollow cylindrical body defines a lumen sized to engage the distal end of the surgical drain with a friction fit or an interference fit that maintains coaxial alignment during rotation; wherein the device is configured to be disposable and is fabricated from a biocompatible material comprising ceramic, plastic, stainless steel, titanium, tungsten carbide, and/or a metal alloy; and wherein the device is configured to be provided in a kit comprising a plurality of otherwise identical devices having differing lumen diameters in a range from about 3 mm to about 7 mm to correspond to differently sized surgical drains.” overcome the rejection as written. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Shah in view of Ries and Beck.
Applicant's arguments filed 8/13/2025 have been fully considered but they are not persuasive.
Regarding claim 19, Applicant argues Joimax GmBH fails to teach “a crown reamer with alternating blunt/sharp edges specifically to avoid skin and drain damage, operating in alternating rotational directions”. As stated previously, "[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. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). The device of Joimax has the same structural components as the claimed invention and is fully capable of the intended use of cutting a suture if desired, to which Applicant agrees (Remarks Page 1). The cutter of Ries as disclosed would include wherein the crown reamer is moveable to cut a suture securing the surgical drain in a patient (the cutter of Ries is capable of cutting bone, thus is capable of cutting a suture) and comprises a plurality of teeth (teeth of toothing 12) wherein each of the plurality of teeth includes at least one blunt edge (48) on a first side and at least one sharp edge (46) on a second side (Figure 3; Paragraph 0055; 0057), the blunt edge being configured to not cut a patient's skin, and the sharp edge being configured to cut through a suture (Paragraph 0057). The cutting tooth faces 46 are designed to cut, thus are a sharp edge and can be configured to cut through a suture. The tooth back 48 is not designed to cut, thus is blunt and can be configured to not cut a patient’s skin. The claims do not define a specific structure for how sharp or blunt the edges are, thus it is seen that if the edge is configured to cut, it is sharp and if the edge is configured not to cut, it is blunt. Although the functions of the claimed device and prior art device are different, the structures are the same, thus the prior art would be fully capable of providing the claimed function. Thus, the rejection to claims 19 and 20 are maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 6, 8-12 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "a friction for or an interference fit". However, interference fit and friction fit are synonymous, thus it is unclear how the fit can comprise one of a friction fit or interference fit. Claims 2, 6, and 8-12 are rejected due to their dependence on claim 1.
Claim 20 recites the limitation “wherein the surgical drains of different sizes have diameters of 3 mm, 4 mm, 5 mm, 6 mm, or 7 mm”, however in claim 19, the drains are only functionally recited. Thus, it is unclear and indefinite as to whether the limitation would be required. Further, no quantity of surgical drains was recited. Thus, it is unclear if the claim requires the surgical drains of different sizes to comprise five drains with one of each listed diameter, or any number of drains with sizes varying from the listed diameters.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6, and 10-12 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 6 recites limitations found in claim 1, specifically “a chamber proximate the first end and having a slot that facilitates the capture of the suture into the chamber, whereby the suture is positioned for cutting by the crown reamer”, thus fails to further limit the claim from which it depends. Claim 10 recites the limitation “wherein the hollow cylindrical body is formed from a biologically acceptable material selected from the group consisting of ceramic, plastic and metal” and claim 11, which depends from claim 10 further recites “wherein the metal is selected from a group consisting of stainless steel, titanium, tungsten carbide and metal alloys”, all of which are present in amended claim 1. Thus claims 10-11 fail to further limit the claim from which they depend. Claim 12 recites the limitation “wherein the hollow cylindrical body is disposable”, which is already recited by claim 1, thus fails to further limit the claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1-2, 6, and 8-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shah et al. (US 20160331945 A1) (previously of record) in view of Ries et al. (US 20080077148 A1) (previously of record) and Beck et al. (US 20130053725 A1).
Regarding claim 1, 6, and 10-12, Shah discloses a surgical drain removal device (5000) for the percutaneous removal of a surgical drain sutured inside of a patient (Figure 10; Paragraph 0055), comprising:
a hollow cylindrical body (5005) with opposed first (5015) and second (proximal end of 5005) open ends, the first end including a cutting means comprising a crown reamer (5010) (Figure 10; Paragraph 0055);
a standard surgical drain (drain tube), the crown reamer on the first end sized to fit snugly over an open, distal end of the standard surgical drain (Paragraph 0055); and wherein the crown reamer is moveable to cut a suture securing the standard surgical drain in a patient and comprises a plurality of teeth (5020) (Figure 10; Paragraph 0055);
wherein an inner surface of the hollow cylindrical body defines a lumen sized to engage the distal end of the surgical drain with a friction fit or an interference fit that maintains coaxial alignment during rotation (as the hollow annular distal end of the shaft is fully capable of forming a friction fit if placed over a surgical drain) (Paragraph 0055);
wherein the device is configured to be disposable (Shah’s device is fully capable of being disposed of, either after one use or after many uses, as Shah does not disclose any reasons for the device to not be disposable); and
wherein the device is configured to be provided in a kit comprising a plurality of otherwise identical devices (there is no teaching in Shah that prevents the device from being in a kit, thus the device is fully capable of being provided in a kit comprising a plurality of otherwise identical devices).
Shah fails to explicitly disclose each of the plurality of teeth includes at least one blunt edge on a first side and at least one sharp edge on a second side, the blunt edge being configured to not cut a patient's skin and to function as a leading edge, and the sharp edge being configured to cut through the suture; a chamber positioned immediately proximal to and enclosing the crown reamer, the chamber having a laterally-opening slot; wherein the laterally-opened slot is radially open and dimensioned smaller than the drain diameter so the slot can capture only the first suture first and wherein the slot is configured to first direct the suture and subsequently second direct the distal end of the surgical drain into the chamber so that the suture is disposed between the crown reamer and the surgical drain; where the slot is configured to position the suture between the reamer and the drain and the opposing blunt/sharp edges prevent cutting the drain while rotating in alternating directions; wherein the crown reamer and the plurality of teeth are oriented such that rotation of the device in a first rotational direction advances only the blunt edges into patient tissue without cutting, and rotation of the device in a second, opposite to the first, rotational direction advances only the sharp edges to cut the suture while avoiding contact with the surgical drain; wherein the device is fabricated from a biocompatible material comprising ceramic, plastic, stainless steel, titanium, tungsten carbide, and/or a metal alloy; and wherein the device is configured to be provided in a kit comprising a plurality of otherwise identical devices having differing lumen diameters in a range from about 3 mm to about 7 mm to correspond to differently sized surgical drains.
However, Ries is directed to a cutting device and teaches a hollow cylindrical body (10) with opposed first (distal end) and second (proximal end) open ends, the first end including a cutting means (12) comprising a crown reamer (a plurality of teeth at an annular distal end of a tube comprises a crown reamer) (Figure 1, 4-6; Paragraph 0038); wherein the crown reamer comprises a plurality of teeth (teeth of toothing 12) wherein each of the plurality of teeth includes at least one blunt edge (48) on a first side and at least one sharp edge (46) on a second side (Figure 3; Paragraph 0055; 0057), the blunt edge being configured to not cut a patient's skin, and the sharp edge being configured to cut through a suture (Paragraph 0057) (The cutting tooth faces 46 are designed to cut, thus are configured to cut through a suture. The tooth back 48 is not designed to cut, thus is configured to not cut a patient’s skin.); wherein the crown reamer and the plurality of teeth are oriented such that rotation of the device in a first rotational direction advances only the blunt edges into patient tissue without cutting, and rotation of the device in a second, opposite to the first, rotational direction advances only the sharp edges to cut the suture while avoiding contact with the surgical drain (Paragraph 0057) (Since the cutting tooth faces 46 are designed to cut, thus are configured to cut through a suture and the tooth back 48 is not designed to cut, the device is fully capable of functioning as such that rotation of the device in a first rotational direction advances only the blunt edges into patient tissue without cutting, and rotation of the device in a second, opposite to the first, rotational direction advances only the sharp edges to cut the suture while avoiding contact with the surgical drain).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shah with the teachings of Ries by incorporating each of the plurality of teeth includes at least one blunt edge on a first side and at least one sharp edge on a second side in order to ensure a proper cut when the device is moved in a first direction and prevent cutting when the device is moved in the opposing direction and wherein the crown reamer and the plurality of teeth are oriented such that rotation of the device in a first rotational direction advances only the blunt edges into patient tissue without cutting, and rotation of the device in a second, opposite to the first, rotational direction advances only the sharp edges to cut the suture while avoiding contact with the surgical drain . A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Shah such that each of the plurality of teeth includes at least one blunt edge on a first side and at least one sharp edge on a second side and wherein the crown reamer and the plurality of teeth are oriented such that rotation of the device in a first rotational direction advances only the blunt edges into patient tissue without cutting, and rotation of the device in a second, opposite to the first, rotational direction advances only the sharp edges to cut the suture while avoiding contact with the surgical drain, as taught by Ries, as both references and the claimed invention are directed to cutting devices and Shah is silent to the sharpness and/or bluntness of the teeth edges.
Further, Ries teaches the cutter diameter ranging from 2 mm to 9.5 mm, thus the first end of the hollow cylindrical body would be configured to fit a surgical drain having a diameter selected from the group consisting of 3 mm to 7 mm (Paragraph 0061).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the diameter of the hollow cylindrical body to range from 2 mm to 9.5 mm such that the device can be configured to fit the standard surgical drain having a diameter selected from the group consisting of 3 mm, 4 mm, 5 mm, 6 mm, and 7 mm as taught by Ries, since it has been held change in size/proportion does not distinguish over the prior art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). n re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). MPEP 2144. Thus, the device of Shah, or multiple of the devices of Shah can be configured to fit a surgical drain having a diameter in a range from about 3 mm to about 7 mm to correspond to differently sized surgical drains.
Additionally, Ries teaches wherein the hollow cylindrical body is formed from a metal (Paragraph 0028; 0040); wherein the metal is stainless steel (Paragraph 0028).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the hollow cylindrical body to comprise stainless steel, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Furthermore, Beck is directed to a cutting device (20”) and teaches a chamber (lumen of 20”) positioned immediately proximal to and enclosing the crown reamer (26) (Figure 9-10; Paragraph 0038; 0061) and having a laterally-opening slot (87) (Figure 9-10; Paragraph 0061) wherein the laterally-opened slot is radially open and dimensioned smaller than the drain diameter (the slot is smaller than the diameter of the chamber thus is smaller than the drain diameter) (since the opening 87 is open into the lumen of the outer needle 20, the device as modified would be fully capable of functioning so the slot can capture only the first suture first and wherein the slot is configured to first direct the suture and subsequently second direct the distal end of the surgical drain into the chamber so that the suture is disposed between the crown reamer and the surgical drain and where the slot is configured to position the suture between the reamer and the drain and the opposing blunt/sharp edges prevent cutting the drain while rotating in alternating directions as"[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 Shah as modified by Ries to include a chamber/shield proximate the first end and having a lateral slot, as taught by Beck, as both references and the claimed invention are directed to cutting 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 Shah as modified by Ries with the teachings of Beck by incorporating a chamber/shield proximate the first end and having a lateral slot in order to allow for passage of a needle or the like between the outside of the device and the inner lumen (Beck Paragraph 0061).
Regarding claim 2, Shah further discloses wherein the crown reamer is moveable to cut a suture securing the surgical drain in a patient without injuring the patient or cutting the surgical drain (Paragraph 0055) (Shah’s cutting elements are designed to cut suture. Shah does not disclose the device injuring the patient or cutting tissue; thus, the crown reamer of Shah is moveable to cut a suture without injuring a patient or cutting the surgical drain).
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ries in view of Joimax GMBH (DE 202005016763 U1) (in text citations correspond with attached Espacenet translation) (previously of record).
Regarding claim 19, Ries discloses a device (1) (which is fully capable of functioning as a surgical drain removal device for the percutaneous removal of a surgical drain sutured inside of a patient. "[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.), comprising:
a hollow cylindrical body (10) with opposed first (distal end) and second (proximal end) open ends, the first end including a cutting means (12) comprising a crown reamer (a plurality of teeth at an annular distal end of a tube comprises a crown reamer) (Figure 1, 4-6; Paragraph 0038);
wherein the first end of the hollow cylindrical body is configured to fit over a distal end of a surgical drain (the first end is hollow and cylindrical, thus is configured to fit over an end of a standard surgical drain, which is a catheter) (Figure 4-6); and
wherein the crown reamer is moveable to cut a suture securing the surgical drain in a patient (the cutter of Ries is capable of cutting bone, thus is capable of cutting a suture) and comprises a plurality of teeth (teeth of toothing 12) wherein each of the plurality of teeth includes at least one blunt edge (48) on a first side and at least one sharp edge (46) on a second side (Figure 3; Paragraph 0055; 0057), the blunt edge being configured to not cut a patient's skin, and the sharp edge being configured to cut through a suture (Paragraph 0057) (The cutting tooth faces 46 are designed to cut, thus are configured to cut through a suture. The tooth back 48 is not designed to cut, thus is configured to not cut a patient’s skin.).
Ries fails to disclose a plurality of surgical drain removal devices wherein each one of the plurality of surgical drain removal devices have different sizes to accommodate standard surgical drains of different sizes.
However, Joimax GMBH discloses a kit for the percutaneous removal of a surgical drain that is sutured inside of a patient, comprising a plurality of cutting devices (1) (which is fully capable of functioning as a surgical drain removal device for the percutaneous removal of a surgical drain sutured inside of a patient. "[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.) (Figure 1A-D, 2A-D; Paragraph 0013), wherein each one of the cutting devices includes a hollow cylindrical body (1) with opposed first (3) and second open ends, the first end including cutting means comprising a crown reamer (4) (teeth 4 formed around the distal end of the shaft is equivalent to a plurality of teeth forming a “crown reamer”) (Figure 1A-D, 2A-D; Paragraph 0002; 0019); wherein the first end of the hollow cylindrical body is configured to fit over a distal end of a surgical drain (the first end of hollow cylindrical body is hollow and comprises a lumen, thus is fully capable of fitting over an end of a surgical drain); and
wherein the crown reamer is moveable to cut a suture securing the standard surgical drain in a patient (the cutting blade is configured for cutting tissue, thus would be fully capable of cutting a suture) (Paragraph 0057); and wherein each of the plurality of cutting devices have different sizes (which would be configured to accommodate surgical drains of different sizes) (Figure 1A-D, 2A-D; Paragraph 0013-14).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Ries to include a plurality of surgical drain removal/cutting devices wherein each of the plurality of surgical drain removal/cutting devices have different sizes to accommodate surgical drains of different sizes, as taught by Joimax GMBH, as both references and the claimed invention are directed to cutting 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 Ries with the teachings of Joimax GMBH by incorporating a plurality of surgical drain removal devices wherein each of the plurality of surgical drain removal devices have different sizes to accommodate surgical drains of different sizes in order to choose a size of cutter required for the specific patient.
As best understood in view of the 112(b) issues above, regarding claim 20, Ries further discloses the cutter diameter ranging from 2 mm to 9.5 mm, thus the cutters would be configured to accommodate the different sizes having diameters of 3 mm, 4 mm, 5 mm, 6 mm, and 7 mm (Paragraph 0061). Additionally, Joimax GMBH teaches cutters with diameters of 7.5, 6.5, 5 and 4 mm, thus the cutters would be configured to accommodate surgical drains of different sizes having diameters of 3 mm, 4 mm, 5 mm, 6 mm, and 7 mm (Paragraph 0013; 0017).
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 ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771