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 Arguments
Applicant's arguments filed 07/27/2026 have been fully considered but they are not persuasive.
Applicant argues that O’Regan fails to disclose or suggest “a syringe having a length comprising an extended tip, wherein the extended tip is at least half of the length of the syringe” as required in claims 1, 11, and 21.
The examiner respectfully disagrees. In light of the amendments, the extended tip of O’Regan is interpreted as inner tubular member 12 which has a “length of the inner tubular member 12 is sufficient for insertion into the rectum of a patient for treatment of hemorrhoidal tissue” (col. 3 lines 34-36 of O’Regan). As shown in the annotated figure below, the interpreted extended tip 12 is at least half of the length of the syringe and therefore meets the claim.
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Annotated Fig. 1 of O’Regan
Applicant argues that the combination of O’Regan and Taylor would not be obvious to one of ordinary skill in the art because Taylor is not in the “same field of endeavor”. Applicant explains that Taylor discloses an arming device for a biopsy syringe and O’Regan discloses a hemorrhoid banding device.
The examiner respectfully disagrees. In response to applicant's argument that the device of Taylor is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the Taylor device is considered analogous art to O’Regan’s device because the references are in the related field of syringes. Both devices are used to create negative pressure differentials and generate suction to a target region. Taylor teaches that providing a syringe device with an ergonomically designed handle is beneficial specifically for syringes used in tight body spaces such as the rectum (col. 5 lines 33-38: “manipulation of…the syringe 64 using the arming devices 10, 60, 110 or 150 for the taking of a biopsy, may be performed single handedly, which is of importance when working in tight body spaces of a patient, such as…the rectum”). The combination of O’Regan and Taylor would lead one of ordinary skill in the art to the conclusion that when treating tighter spaces of a patient such as the rectum with a syringe device, a syringe device having a handle as taught by Taylor is more advantageous than the syringe device without the handle of O’Regan since the syringe with the handle provides the syringe with an ergonomic design that is important for treating that area because it allows better user control and manipulation of the syringe device which is beneficial for O’Regan’s’ intended purpose.
Applicant argues that Taylor teaches away from a combination with O’Regan because the handle design of Taylor is flexible and deformable. Therefore, the combination would render the O’Regan device inoperable.
Examiner respectfully disagrees. The handle or arming device of Taylor is designed to be used with a syringe device and is meant to actuate a plunger of the syringe device (Fig. 6, col. 4 liens 38-41: “the user's fingers 30 will compress or squeeze the arcuate member 112 against the sleeve 114 to deform the member 112, thereby extending the plunger 88 outwardly from the syringe barrel 90”). Since O’Regan is also a syringe device that comprises a plunger that is designed to retract to create a vacuum for tissue engagement (col. 4 lines 38-41: “draws back the plunger 18 past the first shoulder ring 37 so a vacuum is formed in the housing 16 and the hemorrhoidal tissue is pulled into the inner tubular member 12 through the opening 15”), the combination would not result in an inoperable device. Furthermore, Taylor does not criticize, discredit or otherwise discourage the use of the arming device with a syringe device used for the rectum, but explicitly states that it would be important to do so as stated in col. 5 lines 33-38 above. Therefore, Taylor does not teach away from a combination with O’Regan. See MPEP 2143. 01: "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
Applicant argues that Taylor does not teach “a living hinge” but flexible, deformable members such that one of ordinary skill in the art would not look to Feinsod to arrive at the present invention of a single link and lever actuator.
The examiner respectfully disagrees. Both Taylor and Feinsod teach ergonomic syringe actuators for plunger retraction. Taylor’s main intention is to provide a syringe device with an arming device or handle that may either be on both sides of a syringe body (see Fig. 2) or one side of the syringe body (see Fig. 6). In both instances, a user must apply a downward force or pressure to the handle (as shown by the downward arrows in both Figs. 2 and 6 of Taylor) to retract the plunger of the syringe and create a vacuum pressure inside of the syringe as stated above in col. 4 lines 38-41 of Taylor. Feinsod also teaches an ergonomic syringe actuator on one side of the syringe body, but utilizes a lever and link to retract the plunger. Just like Taylors actuator, a downward force or pressure 79 is applied to retract the plunger of the syringe and create a vacuum pressure inside of the syringe (see Fig. 7E, para. 0098 of Feinsod). Therefore, Feinsod teaches an alternative syringe actuator that results in the same function. Since Taylor teaches that syringe actuators are important in use in tight spaces of the patient like the rectum and Feinsod teaches an alternative syringe actuator comprising the lever and link that one of ordinary skill in the art would conclude that the O’Regan device would benefit from the teachings of Taylor and Feinsod. Therefore, the rejection is maintained.
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. This application includes one or more claim limitations that do use the word “means,” 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:
“means of a fixedly mounted hinge element” in claims 2 and 12. The limitation describing the means of a fixedly mounted hinge element in claims 2 and 12 fails to include sufficient structure to perform the recited function of “pivotally mounting”. In the specification, the means of a fixedly mounted hinge element is described as a living hinge (see para. 0045 of the PGPUB (US 20230011444) of the instant application. Therefore, the means of a fixedly mounted hinge element is interpreted as a living hinge or any structural equivalents thereof that pivotally mounts the lever to the syringe.
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 § 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) 1-3, 5, 6, 8, 11-13, 15, 18, 21, 23, 24, 27, 36, 38 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over O’Regan (US 5741273) in view of Taylor (US 4950265) and Feinsod et al. (US 20180271701) [hereinafter Feinsod].
Regarding claims 1 and 21, O’Regan discloses a hemorrhoid banding device 10 for treatment of hemorrhoidal tissue (Fig. 4, abstract, col. 3 lines 27-30, col. 4 lines 64-67, col. 5 lines 1-3; note: the embodiment of Fig. 4 is relied upon, however, Fig. 1 is referenced for like features not described in Fig. 4), the hemorrhoid banding device comprising:
a syringe 12, 16 having a length comprising a barrel 16 and a distal end having an extended tip 12, wherein the extended tip 12 is at least half of the length of the syringe 12, 16 (see annotated Fig. 1 below, Fig. 4, col. 3 lines 27-29: “the ligation device 10 has an inner tubular member 12 with a rounded, bevelled or radiused front end 14” and col. 3 lines 36-38: “The inner tubular member 12 is integral with a plunger housing 16 which has a plunger 18 therein”);
a plunger 18 comprising a proximal end (interpreted as end comprising shoulder 36; Fig. 1, col. 4 lines 8-13), a distal end (interpreted as end comprising the head of plunger 18) and an intermediate portion (interpreted as portion comprising tubular element that connects the head of the plunger to a stem 34 of the plunger, Fig. 1, col. 4 lines 8-13) and wherein the plunger is slidably received in the syringe 12 (Fig. 4, col. 3 lines 27-30 and 36-42, col. 5 lines 5-13) and configured to be moved between
(i) a retracted position (not shown but described in col. 5 lines 5-13), and (ii) an extended position (Fig. 4, col. 5 lines 5-13);
a deployment sheath 22 comprising a distal end (interpreted as end adjacent to elastic band 20) and a proximal end (interpreted as end comprising pusher flange 26) (Fig. 4, col. 3 lines 54-60), wherein the deployment sheath 22 is configured to slidably fit over the extended tip 14 of the syringe 12, 16 (Fig. 4, col. 3 lines 56-63) and is configured to move between
(i) a proximal position (Fig. 4, col. 3 lines 54-63),
(ii) a distal position (Fig. 4, col. 3 lines 54-63), and
an obturator 44 slidably disposed in the syringe 12, 16 distal to the plunger 18 (see Fig. 4, col. 4 lines 64-65: “an obturator 44 is provided which fits inside the inner tubular member 12 as shown in FIG. 4”), wherein the obturator is slidably disposed in the extended tip 12 of the syringe 12, 16 (see Fig. 4), with a portion of the obturator projecting out of the extended tip 12 of the syringe 12, 16 when the plunger 18 is in the extended position (col. 4 lines 66-67 and col. 5 line 1: “The obturator 44 has a button shaped front end 46 which protrudes slightly through the opening 15 at the front end 14 of the inner tubular member 12”).
However, O’Regan fails to disclose a single lever comprising a proximal end and a distal end, with the distal end of the lever being hingedly mounted to the distal end of the syringe; and a single link comprising a proximal end and a distal end, wherein the proximal end of the link is hingedly mounted to the proximal end of the plunger and the distal end of the link is hingedly mounted to the proximal end of the lever, and wherein the single lever and the single link are configured to form an obtuse angle during retraction of the plunger and apply a force only on one side of the plunger.
Taylor in the same field of endeavor of syringe devices 110 teaches a syringe actuator handle 112 comprising a proximal end (interpreted as end comprising collar 130) and a distal end 116, with the distal end 116 being hingedly mounted to a distal end of the syringe 64 (Fig. 6, col. 4 lines 30-33), wherein the proximal end 130 is hingedly mounted to a proximal end of a plunger 88 (Fig. 6, col. 4 lines 30-33), and wherein the handle 112 is configured to retract the plunger 88 and apply a force only on one side of the plunger 88 (Fig. 6, col. 4 lines 36-43).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify device in O’Regan to include the single syringe actuator handle of Taylor in order to allow a user to actuate the syringe single handedly, which is important when working in tight body spaces of a patient such as the rectum (col. 5 lines 33-38 of Taylor).
However, the combination of O’Regan and Taylor fails to disclose a lever and a link, wherein the lever and link are configured to form an obtuse angle during retraction of the plunger.
Feinsod in the same field of endeavor of syringe devices teaches an alternative syringe actuator handle comprising a link 75A, 75B and a lever 75C, 75D connection (see Fig. 7E, para. 0089, 0108), wherein the lever 75C, 75D and the link 75A, 75B are configured to form an obtuse angle during retraction of the plunger 76 (Fig. 7E, para. 0098).
The substitution of one known syringe actuator construction (lever and link as shown in Feinsod) for another (syringe actuator as shown in modified O’Regan) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the lever and link hinged construction shown in Feinsod would have yielded predictable results, namely, an alternative way to provide the syringe with the single link and lever handle that still provides an ergonomic design that allows the user to have better control of the syringe (para. 0134 of Feinsod).
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Annotated Fig. 1 of O’Regan
Regarding claim 2, as discussed above, the combination of O’Regan in view of Taylor and Feinsod makes obvious the device of claim 1 above. Additionally, Feinsod further teaches wherein the distal end of the lever is pivotally mounted to the syringe by means of a fixedly mounted hinge element on the barrel (interpreted as either living hinges, pin joints, spring hinges, or the link, as described in para. 0048 of Feinsod) of the syringe (para. 0048 of Feinsod).
Regarding claim 3, as discussed above, the combination of O’Regan in view of Taylor and Feinsod makes obvious the device of claim 1 above. Additionally, O’Regan discloses comprising a band 20 disposed on the extended tip 14 of the syringe 12, 16 when the deployment sheath 22 is in its proximal position (Fig. 4, col. 3 lines 42-46 of O’Regan).
Regarding claim 5, as discussed above, the combination of O’Regan in view of Taylor and Feinsod makes obvious the device of claim 3 above. Additionally, O’Regan discloses wherein the proximal end of the deployment sheath 22 comprises a thumb tab 26 (Fig. 4, col. 3 lines 58-63 of O’Regan), whereby distal motion of the thumb tab 26 causes distal motion of the deployment sheath 22, whereby to deploy the band 20 from the extended tip 14 of the syringe 12, 16 (Fig. 4, col. 3 lines 58-63 of O’Regan).
Regarding claim 6, as discussed above, the combination of O’Regan in view of Taylor and Feinsod makes obvious the device of claim 1 above. Additionally, O’Regan discloses further comprising an obturator 44 slidably disposed in the syringe 12, 16 distal to the plunger 18 (Fig. 4, col. 4 lines 64-67 and col. 5 line 1 of O’Regan), further wherein the obturator 44 is slidably disposed in the extended tip 14 of the syringe 12, 16 (Fig. 4, col. 4 lines 64-67 and col. 5 line 1 of O’Regan), with a portion of the obturator 44 projecting out of the extended tip 14 of the syringe 12, 16 when the plunger 18 is in its distal position (Note: Fig. 4 illustrates the plunger in the extended position, col. 4 lines 64-67 and col. 5 line 1 of O’Regan).
Regarding claim 8, as discussed above, the combination of O’Regan in view of Taylor and Feinsod makes obvious the device of claim 6 above. Additionally, O’Regan discloses wherein the obturator 44 is separated from the plunger 18 by an air gap (interpreted as space between the proximal end of the obturator and distal end of the plunger, see Fig. 4 of O’Regan).
Regarding claim 23, as discussed above, the combination of O’Regan in view of Taylor and Feinsod makes obvious the device of claim 1 above. Additionally, Feinsod teaches wherein the link 75A, 75B employs a geometry which minimizes deflection under a load (para. 0090, 0098 of Feinsod teaches that the user applies a load 79 onto the link 75A, 75B to retract the plunger and does not state that the link deflects under said load but allows the syringe to generate negative pressure in the barrel).
Regarding claim 36, as discussed above, the combination of O’Regan in view of Taylor and Feinsod makes obvious the device of claim 1 above. Additionally, Feinsod teaches wherein the lever 75A, 75B and the link 75C, 75D are stiff and substantially equal in length (see Fig. 7E, para. 0098: “pressure can then be applied on the first handles 75A, 75B in the direction of the arrows 79, causing the first handles 75A, 75C, and the second handles 75B, 75D to compress and straighten, pulling the plunger extension 73, the plunger 76 and the plunger seal (not shown) rearwardly away from the needle”. Since the lever and link are meant to “compress and straighten” when force is applied, the lever and link are not designed to bow out or flex under pressure and have a level of rigidity or stiffness to achieve that function).
Regarding claim 11, O’Regan discloses a method for banding hemorrhoidal tissue (abstract), the method comprising:
providing a hemorrhoid banding device 10 for treatment of hemorrhoidal tissue (Fig. 4, abstract, col. 3 lines 27-30, col. 4 lines 30-35, 64-67, col. 5 lines 1-3; note: the embodiment of Fig. 4 is relied upon, however, Fig. 1 is referenced for like features not described in Fig. 4), the hemorrhoid banding device comprising:
a syringe 12, 16 having a length comprising a barrel 16 and a distal end having an extended tip 12, wherein the extended tip 12 is at least half of the length of the syringe 12, 16 (see annotated Fig. 1 above, Fig. 4, col. 3 lines 27-29: “the ligation device 10 has an inner tubular member 12 with a rounded, bevelled or radiused front end 14” and col. 3 lines 36-38: “The inner tubular member 12 is integral with a plunger housing 16 which has a plunger 18 therein”);
a plunger 18 comprising a proximal end (interpreted as end comprising shoulder 36; Fig. 1, col. 4 lines 8-13), a distal end (interpreted as end comprising the head of plunger 18) and an intermediate portion (interpreted as portion comprising tubular element that connects the head of the plunger to a stem 34 of the plunger, Fig. 1, col. 4 lines 8-13) and wherein the plunger is slidably received in the syringe 12 (Fig. 4, col. 3 lines 27-30 and 36-42, col. 5 lines 5-13) and configured to be moved between
(i) a retracted position (not shown but described in col. 5 lines 5-13), and (ii) an extended position (Fig. 4, col. 5 lines 5-13);
a deployment sheath 22 comprising a distal end (interpreted as end adjacent to elastic band 20) and a proximal end (interpreted as end comprising pusher flange 26) (Fig. 4, col. 3 lines 54-60), wherein the deployment sheath 22 is configured to slidably fit over the extended tip 14 of the syringe 12, 16 (Fig. 4, col. 3 lines 56-63) and is configured to move between
(i) a proximal position (Fig. 4, col. 3 lines 54-63),
(ii) a distal position (Fig. 4, col. 3 lines 54-63); and
an obturator 44 slidably disposed in the syringe 12, 16 distal to the plunger 18 (see Fig. 4, col. 4 lines 64-65: “an obturator 44 is provided which fits inside the inner tubular member 12 as shown in FIG. 4”), wherein the obturator is slidably disposed in the extended tip 12 of the syringe 12, 16 (see Fig. 4), with a portion of the obturator projecting out of the extended tip 12 of the syringe 12, 16 when the plunger 18 is in the extended position (col. 4 lines 66-67 and col. 5 line 1: “The obturator 44 has a button shaped front end 46 which protrudes slightly through the opening 15 at the front end 14 of the inner tubular member 12”);
placing the extended tip 12 of the syringe 12, 16 into the anus of a patient while the plunger 18 is in the extended position so that the portion of the obturator 44 is projecting out of the extended tip 12 of the syringe (Fig. 4, col. 5 lines 5-8: “The plunger 18 resting and pushing against the outer end of the obturator 44, maintains it in position as the device is being inserted into the rectum”);
retracting the plunger which (i) withdraws the obturator into the extended syringe tip, (ii) applies a vacuum to the extended syringe tip, and (iii) pulls the hemorrhoidal tissue into the extended syringe tip (col. 5 lines 8-13: “Once the ligation device 10 has been positioned, the doctor draws back the plunger 18 and the obturator 44 moves back with the plunger 18 exposing the opening 15 at the front end 14 of the inner tubular member 12 and hemorrhoidal tissue is pulled into the inner tubular member 12 through the opening 15”);
advancing the deployment sheath 22 with a thumb of the user to the distal position so as to place a band on the hemorrhoidal tissue (col. 3 lines 47-53: “When the outer tubular pusher sleeve 22 is pushed forwards toward the front end 14 of the inner tubular member 12, the elastic band is pushed off the front end 14 of the inner tubular member 12 and engages hemorrhoidal tissue which has been sucked into the opening 15 in the front end of the inner tubular member 12” and col. 3 lines 60-63: “The pusher flange 26 allows the pusher sleeve 22 to be pushed by a thumb of an operator so the elastic band 20 is discharged from the front end 14 of the inner tubular member 12”);
withdrawing the hemorrhoid banding device from the anus of the patient (col. 4 lines 46-48: “The ligation device can then be removed and the procedure may be carried out at least three times during one patient's visit to the doctor's office”).
However, O’Regan fails to disclose a single lever comprising a proximal end and a distal end, with the distal end of the lever being hingedly mounted to the distal end of the syringe; and a single link comprising a proximal end and a distal end, wherein the proximal end of the link is hingedly mounted to the proximal end of the plunger and the distal end of the link is hingedly mounted to the proximal end of the lever, and wherein the single lever and the single link are configured to form an obtuse angle during retraction of the plunger and apply a force only on one side of the plunger.
Taylor in the same field of endeavor of syringe devices 110 teaches a syringe actuator handle 112 comprising a proximal end (interpreted as end comprising collar 130) and a distal end 116, with the distal end 116 being hingedly mounted to a distal end of the syringe 64 (Fig. 6, col. 4 lines 30-33), wherein the proximal end 130 is hingedly mounted to a proximal end of a plunger 88 (Fig. 6, col. 4 lines 30-33), and wherein the handle 112 is configured to retract the plunger 88 and apply a force only on one side of the plunger 88 (Fig. 6, col. 4 lines 36-43).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify device in O’Regan to include the single syringe actuator handle of Taylor in order to allow a user to actuate the syringe single handedly, which is important when working in tight body spaces of a patient such as the rectum (col. 5 lines 33-38 of Taylor).
However, the combination of O’Regan and Taylor fails to disclose a lever and a link, wherein the lever and link are configured to form an obtuse angle during retraction of the plunger.
Feinsod in the same field of endeavor of syringe devices teaches an alternative syringe actuator handle comprising a link 75A, 75B and a lever 75C, 75D connection (see Fig. 7E, para. 0089, 0108), wherein the lever 75C, 75D and the link 75A, 75B are configured to form an obtuse angle during retraction of the plunger 76 (Fig. 7E, para. 0098).
The substitution of one known syringe actuator construction (lever and link as shown in Feinsod) for another (syringe actuator as shown in modified O’Regan) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the lever and link hinged construction shown in Feinsod would have yielded predictable results, namely, an alternative way to provide the syringe with the single link and lever handle that still provides an ergonomic design that allows the user to have better control of the syringe (para. 0134 of Feinsod).
Regarding claim 12, as discussed above, the combination of O’Regan in view of Taylor and Feinsod makes obvious the device of claim 11 above. Additionally, Feinsod teaches discloses wherein the distal end of the lever is pivotally mounted to the syringe by means of a fixedly mounted hinge element on the barrel (interpreted as either living hinges, pin joints, spring hinges, or the link, as described in para. 0048 of Feinsod) of the syringe (Fig. 1A, para. 0048 of Feinsod).
Regarding claim 13, as discussed above, the combination of O’Regan in view of Taylor and Feinsod makes obvious the device of claim 11 above. Additionally, O’Regan discloses wherein the band 20 disposed on the extended tip 14 of the syringe 12, 16 when the deployment sheath 22 is in its proximal position (Fig. 4, col. 3 lines 42-46 of O’Regan).
Regarding claim 15, as discussed above, the combination of O’Regan in view of Taylor and Feinsod makes obvious the device of claim 13 above. Additionally, O’Regan discloses wherein the proximal end of the deployment sheath 22 comprises a thumb tab 26 (Fig. 4, col. 3 lines 58-63 of O’Regan), whereby distal motion of the thumb tab 26 causes distal motion of the deployment sheath 22, whereby to deploy the band 20 from the extended tip 14 of the syringe 12, 16 (Fig. 4, col. 3 lines 58-63 of O’Regan).
Regarding claim 18, as discussed above, the combination of O’Regan in view of Taylor and Feinsod makes obvious the device of claim 11 above. Additionally, O’Regan discloses wherein the obturator 44 is separated from the plunger 18 by an air gap (interpreted as space between the proximal end of the obturator and distal end of the plunger, see Fig. 4 of O’Regan).
Regarding claim 24, as discussed above, the combination of O’Regan in view of Taylor and Feinsod makes obvious the device of claim 11 above. Additionally, Feinsod teaches wherein the link 75A, 75B employs a geometry which minimizes deflection under a load (para. 0090, 0098 of Feinsod teaches that the user applies a load 79 onto the link 75A, 75B to retract the plunger and does not state that the link deflects under said load, but allows the syringe to generate negative pressure in the barrel).
Regarding claim 27, as discussed above, the combination of O’Regan in view of Taylor and Feinsod makes obvious the device of claim 11 above. Additionally, Feinsod teaches wherein using the hemorrhoid banding device to apply the band to the hemorrhoidal tissue comprises retracting the plunger by decreasing a distance between the proximal end of the lever and the syringe (see Figs. 1A (plunger in a first position) and 1B (plunger in a second, retracted position, wherein the distance between the syringe and the lever decreased, para. 0046, 0055 of Feinsod).
Regarding claim 38, as discussed above, the combination of O’Regan in view of Taylor and Feinsod makes obvious the device of claim 11 above. Additionally, Feinsod teaches wherein the user retracts the plunger by using the thumb of the single hand to move the lever and link towards the syringe (Fig. 7E, para. 0093, 0095 of Feinsod).
Regarding claim 39, as discussed above, the combination of O’Regan in view of Taylor and Feinsod makes obvious the device of claim 11 above. Additionally, Feinsod teaches wherein the user retracts the plunger by using a middle finger of the single hand to move the lever and link towards the syringe (Fig. 1A, para. 0047, 0050 of Feinsod).
Claim(s) 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over O’Regan (US 5741273) in view of Taylor (US 4950265) and Feinsod et al. (US 20180271701) [hereinafter Feinsod] as applied to claims 6 and 16 above, and further in view of Chotenovsky et al. (US 20150057679) [hereinafter Chotenovsky].
Regarding claims 7 and 17, as discussed above, the combination of O’Regan in view of Taylor and Feinsod makes obvious the device of claims 6 and 16 above. Additionally, O’Regan further discloses wherein the obturator 44 and the plunger 18 are two separate elements (see Fig. 4 of O’Regan). However, modified O’Regan is silent regarding wherein the obturator is fixed to the plunger.
Chotenovsky in the same field of endeavor teaches a hemorrhoid banding device for the treatment of hemorrhoidal tissue (Fig. 1, abstract, para. 0055-0056, 0061) comprising an obturator 26 and a plunger 16 (Figs. 1, 8, para. 0057-0058), wherein the obturator 26 is fixed to the plunger 16 (para. 0058) as a known alternative to the plunger and obturator being separate elements (para. 0073).
The substitution of one known element (the plunger and obturator being fixedly connected as shown in Chotenovsky) for another (the plunger and obturator being separate elements as shown in modified O’Regan) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the combined plunger/obturator element shown in Chotenovsky would have yielded predictable results, namely, providing the device with a single plunger/obturator element (Fig. 8, para. 0073 of Chotenovsky); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim(s) 10, 20, 31, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over O’Regan (US 5741273) in view of Taylor (US 4950265) and Feinsod et al. (US 20180271701) [hereinafter Feinsod] as applied to claims 1, 11, and 21 above, and further in view of Naganuma (US 5468232).
Regarding claims 10, 20, and 31, as discussed above, the combination of O’Regan in view of Taylor and Feinsod makes obvious the device of claims 1, 11, and 21 above. However, modified O’Regan is silent regarding further comprising a locking element to selectively hold the plunger in its retracted position.
Naganuma teaches a syringe 1 (Figs. 1-3, col. 3 lines 10-12) and a plunger 15 configured to be slidably received in the syringe 1 (Figs. 1-3, col. 5 lines 27-32) and movable between (i) a proximal position (shown in Fig. 1), and (ii) a distal position (shown in Fig. 3), and further comprising a locking element 21 to selectively hold the plunger 15 in its retracted position (Figs. 1, 3, col. 4 lines 52-58 and col. 5 lines 1-7).
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 plunger in modified O’Regan to include the locking element of Naganuma in order to lock the plunger in the proximal, retracted, position (as shown in Fig. 1, col. 5 lines 1-7), thereby preventing premature distal movement of plunger (col. 2 lines 48-53 of Naganuma).
Regarding claim 35, as discussed above, the combination of O’Regan in view of Taylor, Feinsod, and Naganuma makes obvious the device of claim 10 above. Additionally Naganuma further teaches wherein the locking element 21 is self-engaging (col. 5 lines 21-25 of Naganuma: “the distal end portion of the engagement member 24 is strongly pressed to bring the partially-fitted projection 27 into complete fitting engagement with the hole 28, thereby releasing the lock mechanism 21”; The examiner notes that the claim does not define what the locking element is self-engaging relative to and is interpreted as an active/intentional engagement relative to the plunger during release of the locking engagement).
Claim(s) 25, 26, 32, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over O’Regan (US 5741273) in view of Taylor (US 4950265) and Feinsod et al. (US 20180271701) [hereinafter Feinsod] and Naganuma (US 5468232) as applied to claims 10, 20, and 31 above, and further in view of Fiser et al. (US 7361159) [hereinafter Fiser].
Regarding claims 25, 26, 32, and 37, as discussed above, the combination of O’Regan in view of Taylor, Feinsod, and Naganuma makes obvious the device of claims 10, 20, and 31 above. Additionally, Naganuma teaches wherein the proximal end of the plunger comprises the locking element (Fig. 1, col. 4 lines 52-58 and col. 5 lines 1-7 of Naganuma). However, modified O’Regan is silent regarding the locking element being configured for engagement with the proximal end of the link (claims 25-26, and 32) and wherein the proximal end of the link comprises a hole for engaging with the locking element (claim 37).
Fiser teaches that it is known in the art to lock a link (interpreted as proximal segment 58 of extensible frame 56 which structure is analogous with the link 75A-B of Feinsod, see Figs, 1A-B, 7D, para. 0048; col. 5 lines 22-30 of Fiser) with a locking element 50 (which structure is analogous to the locking element shown in Naganuma, see Figs. 1, 3) such that a proximal end 42 of an elongate member 44 comprises the locking element 50 and the locking element 50 is configured for engagement with the proximal end of the link 58, wherein the proximal end of the link 58 comprises a hole 66 for engaging the locking element 50 (see Figs. 3A-3, col. 6 lines 58-66) and disengage with the link 58 to unlock the link (Figs. 4A-5, col. 9 lines 22-25) (The examiner notes that the locking element 200 in applicants device does not engage the proximal end of the link 80 nor is the hole on the proximal end of the link 80. As shown in Figs. 17-18 of the instant application, the hole is on a proximal portion of the link 80 and the locking element engages a proximal portion of the link 80. Similarly in Fiser, the hole 66 is on a proximal portion of the interpreted link 58 and the interpreted locking element 50 engages the proximal portion of the link 58, see Figs. 3A-3 of Fiser).
In light of this teaching, 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 link of modified O’Regan to include the hole of Fiser and substitute the locking element of Fiser for the locking element of modified O’Regan, since such a substitution is for one known locking element for another and since the modification would yield predictable results, namely a way for the user to selectively lock the link to the proximal end of plunger (Figs. 3, 4A-5, col. 6 lines 58-66 and col. 9 lines 22-25 of Fiser); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007)
Claim(s) 29 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over O’Regan (US 5741273) in view of Taylor (US 4950265) and Feinsod et al. (US 20180271701) [hereinafter Feinsod] as applied to claims 1 and 11 above, and further in view of Fiser et al. (US 7361159) [hereinafter Fiser].
Regarding claims 29 and 30, as discussed above, the combination of O’Regan in view of Taylor and Feinsod makes obvious the device of claims 1 and 11 above. However, modified O’Regan is silent regarding wherein at least one of the lever or the link comprises a U-shaped geometry.
Fiser in the related art of hinge mechanisms, teaches that it is known in the art to structure a link (interpreted as proximal segment 58 of extensible frame 56 which structure is analogous with the link 75A-B of Feinsod, see Figs, 1A-B, 7D, para. 0048 of Feinsod; col. 5 lines 22-30 of Fiser) and a lever (interpreted as distal segment 60 of extensible frame 56 which structure is analogous with the lever 75C-D of Feinsod, see Figs, 1A-B, 7D, para. 0048 of Feinsod; col. 5 lines 22-30 of Fiser) with a U-shaped geometry (see Figs. 1-2, 12-13 of Fiser).
It would have been an obvious matter of design choice to modify the link and lever of modified O’Regan to be shaped in the U-shaped geometry as taught by Fiser, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
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 LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771
