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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/05/2025 has been entered.
Response to Arguments
Applicant’s arguments, see page 2, filed 12/05/2025, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102(a)(1) in view of Slenker have been fully considered and are persuasive. The examiner agrees that Slenker fails to disclose “wherein the body has a first attachment portion and a second attachment portion, the body defining an upright orientation when the first attachment portion and the second attachment portion are spaced vertically from each other, and wherein the second inlet opening is spaced vertically from the first outlet opening when the body is in the upright orientation” as required in claim 1. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Newman, Jr. (US 20090062751) in view of Bono et al. (US 20140207056) for claim 1 and Newman, Jr. (US 20090062751) in view of Bono et al. (US 20140207056) and Schober et al. (US 20140378954) for claim 28.
Claim Objections
Claims 1 and 24-25 are objected to because of the following informalities:
Claim 1 (lines 8, 14) and claim 28 (line 8, 14): “adhesive or sealant composition” which should recite “the adhesive or sealant composition”.
Claim 24 (line 2): “surface” which should recite “surface.”
Claim 25 (line 2): “width,” which should recite “width.”
Appropriate correction is required.
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.
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) 1, 3-5, 7-8, 24, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Newman, Jr. (US 20090062751) [hereinafter Newman] in view of Bono et al. (US 20140207056) [hereinafter Bono].
Regarding claim 1, Newman discloses an applicator 10 comprising a body 15, 40, 70 (Fig. 1, para. 0028-0029), wherein the body comprises:
a first planar application face surface (interpreted as surface on a distal end of the application that defines distal opening of conduit 70) configured to be positioned facing a biological and/or prosthetic tissue (para. 0034, 0036, 0042), the application face surface defining a first outlet opening (interpreted as opening defined by second end 90 of a channel of the conduit 70) such that the first outlet opening is coplanar with the application face surface (Fig. 1, para. 0039),
a first inlet opening (interpreted as opening defined in a first end 80 of the conduit 70, Fig. 1, para. 0039) for allowing an adhesive or sealant composition to flow from a dispensing device 200 into the applicator (Figs. 1-2, para. 0028, 0039-0040, 0046, see note below), the first outlet opening being shaped as a slot (Fig. 1, para. 0040, The examiner notes that a slot is shaped as a narrow or small opening) for allowing the adhesive or sealant composition to flow out of the applicator and to form a layer of adhesive or sealant composition deposited on a target site of the biological and/or prosthetic tissue (para. 0028, 0039-0040; see note below),
a first inner channel (interpreted as channel defined between the first end 80 and the second end 90) for guiding the adhesive or sealant composition from the first inlet opening to the first outlet opening (Fig. 1, para. 0039-0040),
a second inlet opening (interpreted as opening defined in a second end 46 of the nozzle 40, Fig. 1, para. 0033) provided in a second planar application face surface (interpreted as surface on a distal end of the application that defines distal opening of nozzle 40, Fig. 1, para. 0033), adjacent and below the first outlet opening (Fig. 1, para. 0033), for allowing pollutants or undesirable elements to be removed from the target site while depositing the layer of adhesive or sealant composition (para. 0033-0034, 0037) and creating a depression between a surface of the target site and the adhesive or sealant composition (see note below),
a second outlet opening (interpreted as opening defined in a first end 44 of the nozzle 40, Fig. 1, para. 0033) for allowing the removed pollutants or undesirable elements to be evacuated from the applicator (para. 0033-0034),
a second inner channel 42 for guiding the removed pollutants or undesirable elements from the second inlet opening to the second outlet opening (Fig. 1, para. 0033-0034), wherein the body has a first attachment portion 95 (Fig. 1, para. 0039) and a second attachment portion (interpreted as portion comprising shaft 15, Fig. 1, para. 0029), the body defining an upright orientation when the first attachment portion and the second attachment portion are spaced vertically from each other (Fig. 1, para. 0029, 0039), and wherein the second inlet opening is spaced vertically from the first outlet opening when the body is in the upright orientation (Fig. 1, para. 0033, 0039).
However, Newman fails to disclose a singular planar application face surface.
Bono in the same field of endeavor of suction and irrigation devices (Fig. 1, para. 0028) teaches that it is known in the art to provide the device with a first outlet opening 130 and a second inlet opening 128 (Fig. 18 para. 0061-0062) with first and second planar application face surfaces (see Figs. 18, 19F-19H, para. 0062) or with a singular planar application face surface (see Fig. 19C) as a known alternative.
Therefore, the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention (i.e., one skilled in the art would have recognized that the singular planar application face surface used in Newman would provide an alternative way to shape and configure the openings of the suction and irrigation elements of the applicator in Newman (Fig. 19C, para. 0062 of Bono); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Note: The limitation “for allowing an adhesive or sealant composition to flow from a dispensing device into the applicator” and “for allowing the adhesive or sealant composition to flow out of the applicator and to form a layer of adhesive or sealant composition deposited on a target site of the biological and/or prosthetic tissue” is interpreted as functional language and intended use of the device. Therefore, the “adhesive or sealant composition” is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of flowing into and out of the applicator. Structurally, the claim only requires the first inlet opening and the first outlet opening in order to meet the functional limitation. Modified Newman discloses that the first inlet and outlet openings are for irrigation and delivery fluids to a treatment site (para. 0028, 0039-0040 of Newman). Therefore, the first inlet/outlet openings of modified Newman are capable of allowing an adhesive or sealant composition to flow from a dispensing device into the applicator and for allowing the adhesive or sealant composition to flow out of the applicator and to form a layer of adhesive or sealant composition deposited on a target site of the biological and/or prosthetic tissue. Since, the device of modified Newman meets the structural limitation of the claim, the device of modified Newman also meets the functional limitation.
Note: The limitation “creating a depression between a surface of the target site and the adhesive or sealant composition” is interpreted as functional language. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. Structurally, the claim only requires that the second inlet opening provided in the application face is adjacent the first outlet opening in order to meet the functional limitation. Modified Newman discloses that the second inlet opening which is used for suction/aspiration is adjacent and below the first outlet opening (see Fig. 1, para. 0033-0034 of Newman) and therefore, meets the structural limitation of the claim. Furthermore, since modified Newman discloses that the second inlet opening is coupled to a channel used for aspiration (para. 0033-0034 of Newman), depending on the suction/ aspiration force of the device, the second inlet opening is capable of imparting a suction force such that a depression between a surface of the target site and the adhesive or sealant composition may be created. Since, the device of Newman meets the structural limitation of the claim, the device of Newman also meets the functional limitation.
Regarding claim 3, modified Newman discloses all the limitations set forth above in claim 1. However, modified Newman fails to disclose wherein the first outlet opening shaped as the slot has a first width between 2 and 15 millimeters.
There is no evidence of record that establishes that changing the first width of the first outlet opening would result in a difference in function of the modified Newman device. Further, a person having ordinary skill in the art, being faced with modifying the first outlet opening of Newman such that it has a first width between 2 and 15 millimeters, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed width range (the first outlet opening of modified Newman is intended to dispense fluid to the target site (para. 0028, 0039-0040 of Newman) which is analogous to the intended use of applicant’s first outlet opening). Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that “the first width is comprised between 2 and 15 millimeters, preferably comprised between 5 and 8 millimeters, for instance equal to 3.89 millimeters” (page 16 lines 28-31) and does not include any additional language on the benefits of having the claimed height such that it produces an unexpected result that the device would not perform differently than the prior art device. Therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Hence, 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 first width of the first outlet opening of modified Newman to be between 2 and 15 millimeters as an obvious matter of design choice within the skill of the art.
Regarding claim 4, modified Newman discloses all the limitations set forth above in claim 1. However, modified Newman fails to disclose wherein the first outlet opening shaped as the slot has a first height between 0.2 and 1 millimeters.
There is no evidence of record that establishes that changing the first width of the first outlet opening would result in a difference in function of the modified Newman device. Further, a person having ordinary skill in the art, being faced with modifying the first outlet opening of modified Newman such that it has a first height between 0.2 and 1 millimeters, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed width range (the first outlet opening of modified Newman is intended to dispense fluid to the target site (para. 0028, 0039-0040 of Newman) which is analogous to the intended use of applicant’s first outlet opening). Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that “the first height is comprised between 0.2 and 1 millimeters, preferably between 0.4 and 0.6 millimeters, for instance 0.5 millimeters.” (page 21 lines 8-10) and does not include any additional language on the benefits of having the claimed height such that it produces an unexpected result that the device would not perform differently than the prior art device. Therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Hence, 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 first height of the first outlet opening of modified Newman to be between 0.2 and 1 millimeters as an obvious matter of design choice within the skill of the art.
Regarding claim 5, modified Newman discloses all the limitations set forth above in claim 1. However, modified Newman fails to disclose wherein the second inlet opening has a second height between 0.2 and 5 millimeters.
There is no evidence of record that establishes that changing the second height of the second inlet opening would result in a difference in function of the modified Newman device. Further, a person having ordinary skill in the art, being faced with modifying the second inlet opening of modified Newman such that it has a second height between 0.2 and 5 millimeters, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed height range (the second inlet opening of modified Newman is intended to suction pollutants or undesirable elements from the target site (para. 0033-0034 of Newman) which is analogous to the intended use of applicant’s second inlet opening). Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the second height is comprised between 0.2 and 5 millimeters, preferably between 0.3 and 0.5 millimeters, for instance 2.32 millimeters (page 22 lines 10-12) and does not include any additional language on the benefits of having the claimed height such that it produces an unexpected result that the device would not perform differently than the prior art device. Therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Hence, 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 second height of the second inlet opening of modified Newman to be between 0.2 and 5 millimeters as an obvious matter of design choice within the skill of the art.
Regarding claim 7, modified Newman discloses wherein the first attachment portion 95 is adapted for cooperating with an attachment portion of the dispensing device 200 extending along an axis of attachment in order to attach the applicator to the dispensing device by translating the first attachment portion of the body relative to the attachment portion of the dispensing device (Figs. 1-2, para. 0046-0047 of modified Newman).
Regarding claim 8, modified Newman discloses all of the limitation set forth above in claim 7. Modified Newman further discloses wherein the first attachment portion 95 comprises a female inner surface adapted to fit with a male outer surface of the attachment portion of the dispensing device 200 (Figs. 1-2, para. 0039, 0047 of Newman). However, modified Newman fails to disclose wherein the first attachment portion comprises a male conical outer surface adapted to fit with a female conical inner surface of the attachment portion of the dispensing device, and lugs protruding at a right angle relative to the axis of attachment for locking the first attachment portion of the body to the attachment portion of the dispensing device.
Newman further teaches an alternative embodiment of the device comprising a male conical outer surface 80’ of a first attachment portion (Fig. 3, para. 0057, 0059) adapted to fit with a female conical inner surface of an attachment portion of a dispensing device 400 (Fig. 4, para. 0065), and lugs (see Fig. 3, para. 0057) protruding at a right angle relative to the axis of attachment for locking the first attachment portion of the body to the attachment portion of the dispensing device 400 (para. 0057, 0059, 0065).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include the first attachment portion comprising the male conical outer surface having lugs, as taught by the embodiment of Fig. 3 of Newman, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70 (CCPA 1950).
Regarding claim 24, modified Newman discloses wherein the second inlet opening (interpreted as opening defined in a second end 46 of the nozzle 40, Fig. 1, para. 0033 of Newman) is coplanar with the application face surface (see Fig. 19C, para. 0062 of Bono).
Regarding claim 27, modified Newman discloses wherein the first outlet opening (interpreted as opening defined by the second end 90 of the channel of the conduit 70, Fig. 1, para. 0039 of Newman) has a first section (interpreted as lower section of a face of the applicator body, Figs. 1-2 od Newman)) and the second inlet opening (interpreted as opening defined in a second end 46 of the nozzle 40, Fig. 1, para. 0033 of Newman) has a second section (interpreted as an upper section of the face of the applicator body, Figs. 1-2 of Newman), the second section being greater than the first section (see Fig. 1 which illustrates the second inlet opening sized larger than the first outlet opening, thereby the second, upper, section of the application face defined by the second inlet opening is greater than the first, lower, section of the application face defined by the first outlet opening).
Claim(s) 2, 25-26, and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Newman, Jr. (US 20090062751) [hereinafter Newman] in view of Bono et al. (US 20140207056) [hereinafter Bono], as applied to claim 1, and further in view Schober et al. (US 20140378954) [hereinafter Schober].
Regarding claim 2, modified Newman discloses all of the limitations set forth above in claim 1. Modified Newman further discloses wherein the first outlet opening shaped as the slot has a first width and a first height (Fig. 1, para. 0039 of Newman; The examiner notes that the first outlet opening is shaped as a narrow circle that has a first width and a first height), and the second inlet opening has a second width and a second height (Fig. 1, para. 0033 of Newman; The examiner notes that the second inlet opening is shaped as a circle that has a second width and a second height). However, modified Newman fails to disclose wherein the first outlet opening shaped as the slot has a first width and a first height different from the first width, and the second inlet opening has a second width and a second height different from the second width.
Schober in the same field of endeavor of applicator tips designed to introduce fluid to a target site (Fig. 1, para. 0060) teaches that it is known in the art to design a first opening 03 having a first width and a first height different from the first width (see Fig. 1 which illustrates a rectangle shaped opening, para. 0060), and a second opening 04 having a second width and a second height different from the second width (see Fig. 1 which illustrates a rectangle shaped opening, para. 0060) as a known alternative to circular shaped openings (see Figs. 2-3, para. 0061-0062).
It would have been an obvious matter of design choice to modify the shape of the first outlet opening and the second inlet opening of Newman to be the rectangular shape as taught by Schober, 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).
Regarding claim 25, modified Newman discloses wherein the second width is equal or greater than the first width (Fig. 1, para. 0060 of Schober).
Regarding claim 26, modified Newman discloses all of the limitations set forth above in claim 1. Modified Newman further discloses wherein the first outlet opening and the second inlet opening are circular (see Fig. 1 of Newman). However, modified Newman fails to disclose wherein the first outlet opening and the second inlet opening are rectangular.
Schober in the same field of endeavor of applicator tips designed to introduce fluid to a target site (Fig. 1, para. 0060) teaches that it is known in the art to design a first opening 03 and a second opening 04 to have a rectangular shape (Fig. 1, para. 0060) as a known alternative to circular shaped openings (see Figs. 2-3, para. 0061-0062).
It would have been an obvious matter of design choice to modify the shape of the first outlet opening and the second inlet opening of Newman to be the rectangular shape as taught by Schober, 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).
Regarding claims 28-29, Newman discloses an applicator 10 comprising a body 15, 40, 70 (Fig. 1, para. 0028-0029), wherein the body comprises:
a first planar application face surface (interpreted as surface on a distal end of the application that defines distal opening of conduit 70)) configured to be positioned facing a biological and/or prosthetic tissue (para. 0034, 0036, 0042), the application face surface defining a first outlet opening (interpreted as opening defined by second end 90 of a channel of the conduit 70) such that the first outlet opening is coplanar with the application face surface (Fig. 1, para. 0039),
a first inlet opening (interpreted as opening defined in a first end 80 of the conduit 70, Fig. 1, para. 0039) for allowing an adhesive or sealant composition to flow from a dispensing device 200 into the applicator (Figs. 1-2, para. 0028, 0039-0040, 0046, see note above in the rejection of claim 1 in regards to functional language),
the first outlet opening being shaped as a slot (Fig. 1, para. 0040, The examiner notes that a slot is shaped as a narrow or small opening) for allowing the adhesive or sealant composition to flow out of the applicator and to form a layer of adhesive or sealant composition deposited on a target site of the biological and/or prosthetic tissue (para. 0028, 0039-0040; see note above in the rejection of claim 1 in regards to functional language),
a first inner channel (interpreted as channel defined between the first end 80 and the second end 90) for guiding the adhesive or sealant composition from the first inlet opening to the first outlet opening (Fig. 1, para. 0039-0040),
a second inlet opening (interpreted as opening defined in a second end 46 of the nozzle 40, Fig. 1, para. 0033) provided in a second planar application face surface (interpreted as surface on a distal end of the application that defines distal opening of nozzle 40, Fig. 1, para. 0033), adjacent and below the first outlet opening (Fig. 1, para. 0033), for allowing pollutants or undesirable elements to be removed from the target site while depositing the layer of adhesive or sealant composition (para. 0033-0034, 0037) and creating a depression between a surface of the target site and the adhesive or sealant composition (see note above in the rejection of claim 1 in regards to functional language),
a second outlet opening (interpreted as opening defined in a first end 44 of the nozzle 40, Fig. 1, para. 0033) for allowing the removed pollutants or undesirable elements to be evacuated from the applicator (para. 0033-0034),
a second inner channel 42 for guiding the removed pollutants or undesirable elements from the second inlet opening to the second outlet opening (Fig. 1, para. 0033-0034).
However, Newman fails to disclose a singular planar application face surface.
Bono in the same field of endeavor of suction and irrigation devices (Fig. 1, para. 0028) teaches that it is known in the art to provide the device with a first outlet opening 130 and a second inlet opening 128 (Fig. 18 para. 0061-0062) with first and second planar application face surfaces (see Figs. 18, 19F-19H, para. 0062) or with a singular planar application face surface (see Fig. 19C) as a known alternative.
Therefore, the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention (i.e., one skilled in the art would have recognized that the singular planar application face surface used in Newman would provide an alternative way to shape and configure the openings of the suction and irrigation elements of the applicator in Newman (Fig. 19C, para. 0062 of Bono); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Modified Newman further discloses wherein the first outlet opening and the second inlet opening are circular (see Fig. 1 of Newman). However, modified Newman fails to disclose wherein the first outlet opening and the second inlet opening have at least one pair of parallel sides (claim 28)/are rectangular (claim 29).
Schober in the same field of endeavor of applicator tips designed to introduce fluid to a target site (Fig. 1, para. 0060) teaches that it is known in the art to design a first opening 03 and a second opening 04 to have a rectangular shape (Fig. 1, para. 0060) such that the openings have at least one pair of parallel sides (Fig. 1, para. 0060) as a known alternative to circular shaped openings (see Figs. 2-3, para. 0061-0062).
It would have been an obvious matter of design choice to modify the shape of the first outlet opening and the second inlet opening of Newman to be the rectangular shape as taught by Schober, 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).
Claim(s) 6 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Newman, Jr. (US 20090062751) [hereinafter Newman] in view of Bono et al. (US 20140207056) [hereinafter Bono] as applied to claim 1 above, and further in view of Epstein et al. (US 6063055) [hereinafter Epstein].
Regarding claim 6, modified Newman discloses all of the limitations set forth above in claim 1. Modified Newman further discloses wherein the first inlet opening (interpreted as opening defined in a first end 80 of the conduit 70) has a circular shape (Fig. 1, para. 0039 of Newman). However, modified Newman fails to disclose that the first inner channel has a height which continuously decreases from the first inlet opening to the first outlet opening.
Epstein in the same field of endeavor of irrigation/aspiration devices (Fig. 20, col. 17 lines 8-19) comprising teaches that it is known in the art to include a first inner channel 224 used to deliver fluids to a target site has a height which continuously decreases from the first inlet opening 176 to the first outlet opening 210 (Fig. 18, col. 16 lines 34-40).
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 first inner channel in modified Newman to include the continuous tapered structure of the first inner channel, as shown in Epstein, in order to increase fluid delivery to a target site (col. 16 lines 40-44 of Epstein), thereby preventing clogging or undue viscosity build-up when delivering higher viscosity fluids (col. 16 lines 31-34 of Epstein).
Regarding claim 15, modified Newman discloses an applicator assembly 10, 200, 230 (Fig. 2, para. 0046) comprising:
a dispensing device 200 comprising a reservoir filled with a fluid (Fig. 2, para. 0046-0047, 0050 of Newman), and having an end opening 210 allowing the fluid to flow out of the dispensing device (para. 0047-0048 of Newman) and an applicator according to claim 1 (see rejection of claim 1 over Newman in view of Bono above), adapted to be attached to the dispensing device 200 in order to allow depositing a layer of the fluid composition flowing from the end opening of the dispensing device on a biological tissue (Figs. 1-2, para. 0046-0047, 0050 of Newman).
However, modified Newman fails to disclose an adhesive or sealant composition.
Epstein in the same field of endeavor of irrigation/aspiration devices (Fig. 20, col. 17 lines 8-19) comprising teaches that it is known in the art to deliver an adhesive or sealant composition through an applicator 100 adapted to be attached to the dispensing device 360 (Figs. 7, 20, 31, col. 11 lines 25-41, col. 21 lines 48-67 and col. 22 lines 1-3) in order to allow depositing a layer of the adhesive or sealant composition flowing from the end opening of the dispensing device on a biological tissue (Figs. 20 and 31, col. 20 lines 29-39). Epstein further teaches that the adhesive/sealant composition may include a therapeutic agent to form a multi-component sealant to control bleeding tissues in surgery (col. 18 lines 10-14, col. 19 lines 31-39).
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 fluid in modified Newman to include the multi-component adhesive or sealant composition of Epstein in order to control bleeding at a target site (col. 18 lines 10-14, col. 19 lines 31-39 of Epstein), thereby increasing the utility of the device.
Regarding claim 16, modified Newman discloses further comprising a suction tube (Fig. 2, para. 0055) and wherein the applicator further comprises the second attachment portion comprising a conical bulge 30 (Fig. 1, para. 0029 of Newman) adapted to be inserted in an end opening of the suction tube in order to attach the suction tube to the applicator in order to connect the second inner channel 42 to a suction apparatus 260 (Figs. 1-2, para. 0055 of Newman).
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Newman, Jr. (US 20090062751) [hereinafter Newman] in view of Bono et al. (US 20140207056) [hereinafter Bono] as applied to claims 1 above, and further in view of Suzuki et al. (US 20130253580) [hereinafter Suzuki].
Regarding claim 14, modified Newman discloses all of the limitations set forth above in claim 1. However, modified Newman fails to disclose wherein the body comprises a material opaque to radiations having a wavelength between 350 and 670 nanometers.
Suzuki in the same field of endeavor teaches an adhesive applicator for biological tissue 100 (Figs. 1A-C, para. 0034) comprising a nozzle body 1 (Fig. 1A-C, para. 0036), wherein the nozzle body comprises a semi-transparent or opaque material to radiations having a wavelength between 350 and 670 nanometers (para. 0053 discloses that “The nozzle body 1 may be formed of a semi-transparent or opaque material that provides a light shielding effect, or of a transparent material that allows easy visual confirmation of the content, depending on the nature and purpose of the medical fluid.”. Since 350-670 nm is known in the art as the range for visible light and Suzuki teaches that the user has visible confirmation of the material through the nozzle body due to the semi-transparent or opaque material, the reference reads on the claim.) for the purpose of providing a light shielding effect and/or allows easy visual confirmation of the content within the nozzle body (para. 0053).
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 applicator body in modified Newman to include the semi-transparent/opaque material of Suzuki in order to allow easy visual confirmation of the content within the nozzle body (para. 0053 of Suzuki).
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Newman, Jr. (US 20090062751) [hereinafter Newman] in view of Bono et al. (US 20140207056) [hereinafter Bono] in view of Epstein et al. (US 6063055) [hereinafter Epstein] as applied to claim 15 above, and further in view of Ladet (US 20120041095).
Regarding claim 17, modified Newman discloses all of the limitations set forth above in claim 15. However, modified Newman fails to disclose wherein the adhesive or sealant composition contained in the reservoir comprises a pre-polymer comprising a polymeric unit of the general formula (A-B)n, wherein A represents a substituted or un-substituted ester, B represents a substituted or un-substituted acid ester comprising at least two acid ester functionalities, and n represents an integer greater than 1.
Ladet in the same field of endeavor teaches an adhesive dispensing device 100 (Fig. 1, para. 0068) comprising an adhesive or sealant composition C1, C2 contained in a reservoir 114, 116 (Fig. 1, para. 0069-0070), wherein the adhesive or sealant composition contained in the reservoir comprises a pre-polymer comprising a polymeric unit of the general formula (A-B)n, wherein A represents a substituted or un-substituted ester (para. 0029-0030 discloses the core component of the adhesive/sealant composition is a polyol. According to the specifications of the instant applications, component A may be derived from polyols (see page 5 lines 15-28), B represents a substituted or un-substituted acid ester comprising at least two acid ester functionalities, and n represents an integer greater than 1 (para. 0033-0034 discloses that the in addition to polyols, a polyacid such as diacids maybe used to form the core component of the adhesive/sealant composition. According to the specifications of the instant applications, component B may be derived from diacids (see page 5 lines 29-32 and page 6 lines 1-6) for the purpose of creating an injectable adhesive composition (para. 0058, 0080)
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 adhesive/sealant composition material in modified Newman to include the adhesive/sealant composition material of Ladet since it is well within the general skill of one skilled in the art to select a known material based on its suitability for its intended use. (In re Leshin 125 USPQ 416; MPEP 2144.07).
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Newman, Jr. (US 20090062751) [hereinafter Newman] in view of Bono et al. (US 20140207056) [hereinafter Bono] in view of Epstein et al. (US 6063055) [hereinafter Epstein] as applied to claim 15 above, and further in view of Capozzi et al. (US 4978336) [hereinafter Capozzi].
Regarding claim 18, modified Newman discloses all of the limitations set forth above in claim 15. However, modified Newman fails to disclose wherein the dispensing device comprises a syringe having a cylinder defining the reservoir, and a piston slidably mounted within the cylinder, and comprising a casing adapted to be arranged around the cylinder so as to prevent light from irradiating the adhesive or sealant composition contained within the reservoir.
Capozzi teaches it is known in the art of irrigation systems for a dispensing device 14 comprises a syringe 24, 26 having a cylinder defining a reservoir (interpreted as the barrel of the syringe, which is known in the art to be cylindrical, that retains fluid material) (Fig. 1, col. 2 lines 28-41 and 47-50), and a piston (interpreted as syringe plungers) slidably mounted within the cylinder (Fig.1, col. 2 lines 50-54), and comprising a casing 12, 14 adapted to be arranged around the cylinder so as to prevent light from irradiating the adhesive or sealant composition contained within the reservoir (Fig. 1, col. 2 lines 47-50).
The substitution of one known fluid source (casing comprising the syringes having the reservoir as shown in Capozzi) for another (dispensing device as shown in modified Newman) 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 dispensing device shown in Capozzi would have yielded predictable results, namely, an alternative way to deliver fluid to the first channel of the applicator (col. 2 lines 47-54 of Capozzi); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Newman, Jr. (US 20090062751) [hereinafter Newman] in view of Bono et al. (US 20140207056) [hereinafter Bono] in view of Epstein et al. (US 6063055) [hereinafter Epstein] and Capozzi et al. (US 4978336) [hereinafter Capozzi] as applied to claim 18 above, and further in view of Leckebusch et al. (US 20160136637) [hereinafter Leckebusch].
Regarding claim 19, modified Newman discloses all of the limitations set forth above in claim 18. Modified Newman further discloses wherein the casing 12, 14 comprises resilient tabs 46, 48 for attaching to the cylinder of the syringe (Fig. 2, col. 3 lines 1-8 of Capozzi). However, modified Newman fails to disclose that the resilient tabs are adapted to be deformed upon insertion of the cylinder within the casing and to abut against a shoulder of the syringe once the cylinder has been inserted in the casing, so as to lock the casing on the cylinder.
Leckebusch teaches a connection assembly 1 for attaching a syringe 12 to a connecting element 22 (Figs. 1-2, para. 0030) comprising a casing 30 comprising resilient tabs 68 having locking segments 32 which are adapted to be deformed upon insertion of a cylinder 20 with cavity 30 within the casing 30 (Figs. 2, 6, para. 0033, 0037-0039) and to abut against a shoulder 46 of the syringe 12 once the cylinder 20 has been inserted in the casing 30, so as to lock the casing 30 on the cylinder 20 (Figs. 1-2, 6, para. 0037-0039) for purpose of providing a mechanical connection between the connecting element and syringe body (para. 0033).
The substitution of one known locking mechanism (resilient tabs 68 which mate externally with the syringe as shown in Leckebusch) for another (resilient tabs 46, 48 which mate internally with the syringe as shown in modified Newman) 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 locking mechanism shown in Leckebusch would have yielded predictable results, namely, an alternative way to attach the syringes to the casing, thereby providing a leak tight connection between the casing and the syringes (para. 0041 of Leckebusch); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Newman, Jr. (US 20090062751) [hereinafter Newman] in view of Bono et al. (US 20140207056) [hereinafter Bono] on view of Epstein et al. (US 6063055) [hereinafter Epstein] as applied to claim 15 above, and further in view of Hensler et al. (US 20130053828) [hereinafter Hensler].
Regarding claim 20, modified Newman discloses all of the limitations set forth above in claim 15. However, modified Newman fails to disclose comprising a packaging for enclosing the applicator and the dispensing device, the packaging being made of a material preventing penetration of bacteria.
Hensler discloses an anti-clog tip apparatus 10 comprising a packaging for enclosing the device (Fig. 26, para. 0070), the packaging being made of a material preventing penetration of bacteria (para. 0070 defines the packaging as a sterile packaging. It is known in the art that sterile packaging is a packaging free from bacteria and includes material preventing penetration of bacteria).
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 system in modified Newman to include the sterile packaging of Hensler in order to protect the device from bacteria (para. 0070 of Hensler).
Alternative rejection to claim 1 to reject claims 12 and 13
Claim(s) 1 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Newman, Jr. (US 20090062751) [hereinafter Newman] in view of Bono et al. (US 20140207056) [hereinafter Bono].
Regarding claim 1, Newman discloses an applicator 10 comprising a body 40, 70 (Fig. 1, para. 0028-0029), wherein the body comprises:
a first planar application face surface (interpreted as surface on a distal end of the application that defines distal opening of conduit 70) configured to be positioned facing a biological and/or prosthetic tissue (para. 0034, 0036, 0042), the application face surface defining a first outlet opening (interpreted as opening defined by second end 90 of a channel of the conduit 70) such that the first outlet opening is coplanar with the application face surface (Fig. 1, para. 0039),
a first inlet opening (interpreted as opening defined in a first end 80 of the conduit 70, Fig. 1, para. 0039) for allowing an adhesive or sealant composition to flow from a dispensing device 200 into the applicator (Figs. 1-2, para. 0028, 0039-0040, 0046, see note above in the rejection of claim 1 regarding functional language), the first outlet opening being shaped as a slot (Fig. 1, para. 0040, The examiner notes that a slot is shaped as a narrow or small opening) for allowing the adhesive or sealant composition to flow out of the applicator and to form a layer of adhesive or sealant composition deposited on a target site of the biological and/or prosthetic tissue (para. 0028, 0039-0040; see note above in the rejection of claim 1 regarding functional language),
a first inner channel (interpreted as channel defined between the first end 80 and the second end 90) for guiding the adhesive or sealant composition from the first inlet opening to the first outlet opening (Fig. 1, para. 0039-0040),
a second inlet opening (interpreted as opening defined in a second end 46 of the nozzle 40, Fig. 1, para. 0033) provided in a second planar application face surface (interpreted as surface on a distal end of the application that defines distal opening of nozzle 40, Fig. 1, para. 0033), adjacent and below the first outlet opening (Fig. 1, para. 0033), for allowing pollutants or undesirable elements to be removed from the target site while depositing the layer of adhesive or sealant composition (para. 0033-0034, 0037) and creating a depression between a surface of the target site and the adhesive or sealant composition (see note above in the rejection of claim 1 regarding functional language),
a second outlet opening (interpreted as opening defined in a first end 44 of the nozzle 40, Fig. 1, para. 0033) for allowing the removed pollutants or undesirable elements to be evacuated from the applicator (para. 0033-0034),
a second inner channel 42 for guiding the removed pollutants or undesirable elements from the second inlet opening to the second outlet opening (Fig. 1, para. 0033-0034), wherein the body has a first attachment portion (interpreted as portion of conduit 70 that attaches to a distal end of connector 95; Fig. 1, para. 0039) and a second attachment portion (interpreted as portion of nozzle 40 described in para. 0029 that attached to a distal, ribbed, end of shaft 15; Fig. 1, para. 0029), the body defining an upright orientation when the first attachment portion and the second attachment portion are spaced vertically from each other (Fig. 1, para. 0029, 0039), and wherein the second inlet opening is spaced vertically from the first outlet opening when the body is in the upright orientation (Fig. 1, para. 0033, 0039).
However, Newman fails to disclose a singular planar application face surface.
Bono in the same field of endeavor of suction and irrigation devices (Fig. 1, para. 0028) teaches that it is known in the art to provide the device with a first outlet opening 130 and a second inlet opening 128 (Fig. 18 para. 0061-0062) with first and second planar application face surfaces (see Figs. 18, 19F-19H, para. 0062) or with a singular planar application face surface (see Fig. 19C) as a known alternative.
Therefore, the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention (i.e., one skilled in the art would have recognized that the singular planar application face surface used in Newman would provide an alternative way to shape and configure the openings of the suction and irrigation elements of the applicator in Newman (Fig. 19C, para. 0062 of Bono); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 12, modified Newman discloses all of the limitations set forth above in claim 1. Modified Newman further discloses wherein the body is oriented in the upright orientation during use of the applicator (Figs. 1-2, para. 0034, 0039, 0044-0045 of Newman) and wherein the nozzle 40 is composed of a pliable material (para. 0032 of Newman). However, modified Newman fails to disclose the material forming the conduit 70 (para. 0029, 0039 of Newman) and thereby fails to disclose wherein the body is one single piece of material.
It is not explicitly disclosed if the body is one single piece of material. However, there are only a finite number of ways to form the body, either with one single piece of material or with multiple pieces of material. Therefore, it would be obvious to one of ordinary skill to try a configuration wherein the body of modified Newman is one single piece of material. Doing so would provide the predictable result of the body being one single piece of material; KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Newman, Jr. (US 20090062751) [hereinafter Newman] in view of Bono et al. (US 20140207056) [hereinafter Bono] as applied to claims 12 above, and further in view of Suzuki et al. (US 20130253580) [hereinafter Suzuki].
Regarding claim 13, modified Newman discloses all of the limitations set forth above in claim 12. However, However, modified Newman fails to disclose wherein the material is transparent or translucent to visible light so that an observer can see the adhesive or sealant composition flowing within the first inner channel.
Suzuki in the same field of endeavor teaches an adhesive applicator for biological tissue 100 (Figs. 1A-C, para. 0034) comprising a nozzle body 1 (Fig. 1A-C, para. 0036), wherein the nozzle body comprises the material is transparent or translucent to visible light so that an observer can see the adhesive or sealant composition flowing within a first inner channel 1c (para. 0053 discloses that “The nozzle body 1 may be formed of a semi-transparent or opaque material that provides a light shielding effect, or of a transparent material that allows easy visual confirmation of the content, depending on the nature and purpose of the medical fluid.”) for the purpose of providing a light shielding effect and/or allows easy visual confirmation of the content within the nozzle body (para. 0053).
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 applicator body in modified Newman to include the transparent or translucent material of Suzuki in order to allow easy visual confirmation of the content within the nozzle body (para. 0053 of Suzuki).
Conclusion
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771