DETAILED ACTION
This Office Action is in response to Applicant’s amendment filed 19 March 2026.
Notice of 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 .
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 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.
Response to Arguments
In the response filed 19 March 2026, Applicant argues Cabrera Aquino’056 fails to teach the band element (42) is configured to be pulled at a free end, as required by amended claim 1. This argument is persuasive. However, upon further search and consideration, a new secondary reference is relied on to teach this feature. See the updated rejection below.
Claim Objections
Claim 1 objected to because of the following informalities:
Claim 1 uses the word “tigtened” in the second to last line. This is a typographical error and should be corrected to recite “tightened”.
Claim 19 recites “increasing as well as decreasing” in line 14. Examiner suggests reciting “increasing and decreasing” to be more concise and clearer.
Appropriate correction is required.
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 19-21 is 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 pre-AIA the applicant regards as the invention.
Claim 19 recites the limitation “the free end comprising one or more gripping element in the form an eyelet and a hook at an end opposite the joining region”. It is unclear if Applicant is intending to recite both an eyelet and a hook or one of an eyelet and a hook. The specification discloses an eyelet or a hook. Therefore, for the purpose of examination, Examiner will interpret this limitation to recite one of an eyelet and a hook.
Examiner suggests amending the claim to recite:
“the free end comprising at least one gripping element in the form an eyelet or a hook
Claims 20-21 are rejected based on their dependency from claim 19.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-7, 9-13, 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Cabrera Aquino et al. (US Patent Publication 2015/0066056) in view of Benz et al. (US Patent Publication 2012/0053617).
Claim 1: Cabrera Aquino’056 teaches a medical instrument (10) for reducing the blood flow through a blood vessel of a human or animal (paragraph [0129], [0008]) having:
a band element (40), which is fastened to a handling unit (26) with a joining region (paragraph [0287] describes how 41 is fixed to the handling unit) and which has a band portion (42) movable relative to the joining region (paragraph [0304]),
which band portion (5) forms a loop (Figure 1a shows portions 41, 42 are connected to form a loop) and is guided in an adjusting unit (22), at least indirectly fastened to the handling unit (26; Figure 1a shows 22 is fastened to 26), with an actuation element (21) in such a way that, due to an actuation of the actuation element (21), the band portion (42) can be moved relative to the joining region and thus a size and/or shape of a surface area enclosed by the loop can be changed (paragraph [0301]),
the at least one fixing means (ratchet, paragraph [0299]) is provided for at least temporarily locking the movable band portion (42) and in that, by actuation of the actuation element (21), the movable band portion (42) can be transferred in a targeted manner from the locked position to a position for increasing as well as decreasing the surface area enclosed by the loop (paragraph [0299] [0301]).
Cabrera Aquino’056 does not teach the band element is configured such that the loop can be tightened by manually pulling at the free end of the of the band element.
It is old and well known to provide adjustable surgical bands with course/gross and fine adjustment mechanisms. For example, Benz’617 teaches a band element (80) fastened to a handling unit (82) at a joining region (the joining region is at the end of band 80 attached to handling unit 82; this end is opposite to the free end 85 of band 80). The band element (80) forms a loop (Figure 9) which is guided in an adjusting unit (60) fastened to the handling unit (82). There is an actuation element (61) that allows for moving the band portion relative to the joining region (paragraph [0075]) to provide fine adjustment of the band size.
The band element (80) is also configured such that the loop can be tightened by manually pulling at the free end (85) of the band element (paragraph [0072]) to provide course/gross adjustment of the band size.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Cabrera Aquino’056 such that the free end of the strap 42 can be manually pulled by a user, as taught by Benz’617, in order to allow for quick and gross changes in the size of the clamp opening 40 in addition to fine changes provided by actuation element 21.
Claim 2: Cabrera Aquino’056 teaches the fixing means (“teeth”, paragraph [0299]) at the band element (40) has latching lugs, latching teeth, grooves, holes, notches and/or hooks formed at least in sections (paragraph [0299] discloses the band 42 has teeth which engage with the adjusting unit 22).
Claim 3: Cabrera Aquino’056 teaches the fixing means (“teeth”, paragraph [0299]) is in operative connection with the adjusting unit (22) at least in certain areas (paragraph [0299] discloses the teeth on band 42 are engaged with teeth on wheel 22; paragraph [0298] discloses wheels 21, 22 are fixed and move together).
Claim 4: Cabrera Aquino’056 teaches the adjusting unit (22) has a clamping mechanism (24; ratchet means which engages with teeth on wheel 21; wheels 22 and 21 are connected and move together).
Claim 5: Cabrera Aquino’056 teaches the clamping mechanism (24) is formed by part of the actuation element (21) (ratchet 24 engages with teeth on actuation element 21; Figure 2).
Claim 6: Cabrera Aquino’056 teaches the clamping mechanism has at least one wheel that moves relative to the joining region of the band element (wheel 21 moves relative to the joining region of the band element because it rotates; Figure 3a).
Claim 7: Cabrera Aquino’056 teaches the actuation element (21) is a rotary wheel (Figure 2, 3a, 3b).
Claim 9: Cabrera Aquino’056 teaches the band element is made from a plastic material (paragraph [0199]); the handling unit (26) is made from plastic (paragraph [0293]).
Cabrera Aquino’056 does not explicitly disclose the adjusting unit (22) is made from plastic. However, it is deemed to be within the level of ordinary skill in the art to use a known material. “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” See §MPEP 2144.07.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to make the adjusting unit (22) of plastic 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.
Claim 10: Cabrera Aquino’056 teaches the handling unit (26) has a grip area with a recess or surface structured at least in certain areas (outer surface of 26 is disclosed as a “pistol grip handle” in paragraph [0292] and it has an opening 27 which is a recess).
Claim 11: Cabrera Aquino’056 teaches the adjusting unit (22) and the fixing means (“teeth”, paragraph [0299]) are designed that the size of the surface area enclosed by the loop (41, 42) can be changed in discrete steps (paragraph [0299] states the wheel 22 has teeth which engage with teeth on the band; paragraph [0298] states wheel 22 moves with wheel 21 which engages with a ratchet mechanism and limits movement of the loop to “ratchet clicks” described in paragraph [0304])
Claim 12: This claim is directed towards the intended use of the device. Cabrera Aquino’056 at paragraph [0287] states the band (41) can be attached to the handing unit (26) via any known means, including an adhesive, pins, slots, screws and grooves. These mechanisms do not necessarily require tools.
Claim 13: Cabrera Aquino’056 teaches the movable band portion (42) is guided in a guide channel (32).
Cabrera Aquino’056 does not disclose the guide channel has a square cross-section. However, it’s been held that mere changes in shape are a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular shape is significant.
In this case, the specification discloses no reason for using a guide channel with a square cross-sectional. Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Cabrera Aquino’056 such that the guide channel has a square cross-section because it has been held that mere changes in shape are an obvious matter of design choice. The guide channel 32 of Cabrera Aquino’056 would perform equally as well at guiding the band (40) towards the handling unit regardless of whether the guide channel has a shape as disclosed by Cabrera Aquino’056 or a square cross sectional shape because both guide channel cross-sections would perform the same function of providing a channel through which the band passes to reach the handling unit.
Claim 16: Cabrera Aquino’056 does not teach the width of the band (41, 42) is 0.8 to 1.2 cm. However, Cabrera Aquino’056 teaches the dimensions of the individual components of the device, including the band, can be adjusted based on the procedure to be performed, the user of the device, the specific target tissue being treated and other facts within the level of a skilled artisan (paragraphs [0283], [0320]).
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the band portion of Cabrera Aquino’056 to have a width of about 1cm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the band portion of Cabrera Aquino’056 would not operate differently with the claimed width and Cabrera Aquino’056 teaches that it would be obvious to vary the width, as needed (paragraphs [0283], [0320]). Further, applicant places no criticality on the range claimed, indicating simply that the diameter “may” be within the claimed ranges (specification at paragraph [0031]).
Claim 17: Cabrera Aquino’056 teaches a guide channel (32) has an opening at its distal end (Figure 1a) which is formed such that the movable band portion (42) under goes a deflection relative to its orientation in the guide channel (32) (Figure 1a).
Claim 18: Cabrera Aquino’056 teaches a handing unit and a band, as discussed in the rejection to claim 1, above. Cabrera Aquino’056 does not teach a second band. However, it’s been held it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
In this case, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device of Cabrera Aquino’056 by providing a second band such has one having different characteristics, so that the user can choose the band that works best for the particular procedure (paragraphs [0283], [0320]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Cabrera Aquino’056 in view of Benz’617, as applied to claim 1, further in view of Patel et al. (US Patent Publication 2010/0234862).
Cabrera Aquino’056, as modified, teaches the limitations of claim 14 except that the band element has a roughened surface which is configured to rest against the patient during use.
Like Cabrera Aquino’056, Patel’862 teaches a band (1) for clamping tissue. Patel’862 teaches the band has a roughened surface (22) for resting against a patient during use in order to aid in holding the band in place (paragraph [0024]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Cabrera Aquino’056 such that the band has a roughened surface, as taught by Patel’862, in order to aid in holding the band in place (paragraph [0024]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Cabrera Aquino’056 in view of Benz’617, as applied to claim 1, further in view of Sutherland et al. (US Patent 4,730,615).
Claim 15: Cabrera Aquino’056, as modified, teaches the limitations of claim 15 except that the band element is a plastic-coated wire.
Like Cabrera Aquino’056, Sutherland’615 teaches a band (10) for securing on tissue. Sutherland’615 teaches constructing the band of stainless steel and coating it with a polymer (column 3, lines 7-12).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Cabrera Aquino’056 such that the band is made of a metal coated with a polymer, as taught by Sutherland’615, in order to impart the band with the strength of metal while providing a relatively softer surface to directly contact tissue. Further, it is deemed to be within the level of ordinary skill in the art to use a known material. “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” See §MPEP 2144.07.
Claims 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Cabrera Aquino’056 in view of Benz’617 in view of Parsons (US Patent Publication 2021/0000482).
Claim 19: Cabrera Aquino’056 teaches a medical instrument (10) for reducing the blood flow through a blood vessel of a human or animal (paragraph [0129], [0008]), the medical instrument comprising:
a handling unit (26);
an adjusting unit (22);
a band element (40) fastened to a handling unit (26) with a joining region (paragraph [0287] describes how 41 is fixed to the handling unit), the band element comprising a band portion (42) movable relative to the joining region (paragraph [0304]), the band portion forming a loop (Figure 1 shows portions 41, 42 are connected to form a loop), wherein a portion of the band element is guided in the adjusting unit (22; figure 2), wherein the band element (40) is at least indirectly fastened to the handling unit (26; Figure 1a shows 22 is fastened to 26);
an actuation element (21) configured to actuated such that the band portion is movable relative to the joining region to change one or more of a size and shape of a surface area enclosed by the loop (paragraph [0301]);
a fixing means (ratchet, paragraph [0299]) for at least temporarily locking the movable band portion (42), wherein the band portion (42) is configured to be transferred in a targeted manner via actuation of the actuation element (21) from a locked position to a position for increasing and decreasing the surface area enclosed by the loop (paragraph [0301]).
Cabrera Aquino’056 does not teach the band element is configured such that the loop can be tightened by manually pulling at the free end of the of the band element.
It is old and well known to provide adjustable surgical bands with course/gross and fine adjustment mechanisms. For example, Benz’617 teaches a band element (80) fastened to a handling unit (82) at a joining region (the joining region is at the end of band 80 attached to handling unit 82; this end is opposite to the free end 85 of the band element 80). The band element (80) forms a loop (Figure 9) which is guided in an adjusting unit (60) fastened to the handling unit (82). There is an actuation element (61) that allows for moving the band portion relative to the joining region (paragraph [0075]) to provide fine adjustment of the band size.
The band element (80) is also configured such that the loop can be tightened by manually pulling at the free end (85) of the band element (paragraph [0072]) to provide gross/course adjustment of the band size.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Cabrera Aquino’056 such that the free end of the strap 42 can be manually pulled by a user, as taught by Benz’617, in order to allow for quick and gross changes in the size of the clamp opening 40 in addition to fine changes provided by actuation element 21.
Benz’617 does not teach the free end has a gripping element in the form of an eyelet.
It is old and well known to provide a gripping surface with an eyelet to aid in gripping. Like Benz’617, Parsons’482 teaches a band element (100) with a free end (102) that passes through an adjusting unit (106). The free end is pulled to tighten the loop of the band element. The free end (102) is provided with an eyelet (130) in order to allow a user’s thumb to pass through and aid in pulling the band element.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Benz’617, such that the free end has an eyelet, as taught by Parson’482, in order to provide the user with an additional, secure gripping surface for pulling on the free end of the band portion.
Claim 20: Cabrera Aquino’056 teaches the actuation element (21) is a rotary wheel (Figure 2, 3a, 3b).
Claim 21: In the resulting device of Cabrera Aquino’056 in view of Benz’617, Cabrera Aquino’056’s band element 42 has a free end near the handling unit 26 that can be gripped, as taught by Benz’617. The free end of the band element 42 can be moved in a direction away from the handling unit to decrease the surface area of the loop (paragraph [0301] teaches turning the wheel 21 turned to pull the band 42 and tighten the loop; this action will also tighten the loop if pulling is performed manually, as taught by Benz’617).
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 extension fee 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 date of this final action.
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 8 April 2026
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771