DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This Office action is in response to the applicant’s communication filed 02/03/2026.
Status of the claims:
Claims 1 – 16 are pending in the application.
Claims 1, 4, 5, 8, 9, and 13 are amended.
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.
The rejections of claims 4 and 8 under U.S.C 35 112(b) regarding indefiniteness, recited in the previous action dated 11/10/2025 have been withdrawn in light of the Applicant’s amendments filed 02/03/2026. Specifically, the rejections of claims 4 and 8, regarding the phrase "said section diameter", have been withdrawn as the appropriate corrections have been made.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 – 16 are rejected under 35 U.S.C. 103 as being unpatentable over Rockley et al (US 2001/0003155 A1) (previously recited) and in view of Chan et al (US 2011/0196303 A1) (previously recited), Dimalanta, Jr et al (US 2010/0056991 A1) (previously recited), and Perkins (US 2022/0323669 A1) (previously recited).
Regarding claims 1, 2, 9, 10, and 12, Rockley discloses a phacoemulsification system (ocular handpiece 100) (abstract, paragraphs [0002 – 0004], [0063], [0065], and Fig. 1) comprising:
a phacoemulsification probe (handpiece 30) (paragraph [0065], and Fig. 1);
an aspiration tube (lines 40 and 42) connectable to said phacoemulsification probe to aspirate a cataract from an eye (paragraph [0065] and Fig. 1); and
an irrigation tube (line 36) connectable to said phacoemulsification probe (paragraph [0065]).
However, Rockley is silent regarding (i) [claims 1 and 9] having at least one integrated compliant tube section / a compliant section tube section at an end near said phacoemulsification probe, (ii) wherein each of said at least one integrated compliant tube section is less than 1% of a length of said irrigation tube, (iii) [claims 1 and 9] has a section diameter larger than a tube diameter of said irrigation tube, (iv) [claims 1, 9, 10, and 12] is configured to absorb intraocular pressure (IOP) fluctuations of the eye during irrigation and aspiration, is made up of a compliant material / silicone, and (v) [claim 2] wherein said at least one integrated compliant tube section is at least one balloon integrally formed in said irrigation tube.
As to the (i) – (v), Chan teaches an irrigation tube (inlet and outlet tubing 174 / 176; which equates to the irrigation tube of Rockley) (abstract, paragraphs [0053 – 0054], and Fig. 12) comprising a long tube portion (inlet and outlet tubing 174 / 176, respectively) (paragraphs [0053 – 0054] and Fig. 12) and at least one integrated compliant tube section (dampener 170) comprising at least one balloon (Examiner’s note: a balloon is defined as an inflatable structure made up of plastic, and, as discussed in paragraphs [0053 – 0055], the dampener 170 is made up of silicone and is inflatable. Therefore, the dampener 170 is considered to be a balloon) connectable to an end of said long tube portion (shown in Fig. 12) for the purpose of dampening pressure fluctuations of the pulsatile flow and to smoothen the pulsatile fluid flow (paragraphs [0007 – 0008]), wherein said compliant tube section has a section diameter larger than a tube diameter of said irrigation tube (shown in Fig. 12) (Examiner’s note: in the expanded state, shown in Fig. 12, the section diameter is larger than the tube diameter. Additionally, Chan recites in paragraph [0054] wherein the dampener 170 is similar to the dampener 160, and in paragraph [0053], recites, wherein the walls of the dampener expand due to the pressure spike; therefore, the walls of the dampener 170 would also expand, and since paragraph [0054] states that the diameter of the dampener 170 is substantially equal to the tube diameter, then when the dampener 170 is expanded the diameter will be greater than the tube diameter), and made up of a compliant material / silicone (paragraph [0053 – 0055]). Additionally, it is noted that Chan further teaches, in a separate embodiment, wherein the compliant tube section (dampener 140; which equates to the dampener 170) is integrally formed with the infusion line (i.e., the irrigation line) (paragraph [0050]), therefore, Chan teaches it is well within the purview of, and would be obvious to, one of ordinary skill in the art to integrally form the compliant tube section with the infusion line (i.e., the irrigation line) as integrally forming a compliant section with the infusion line is a known method of connecting known elements (i.e., a compliant tube section and an irrigation line), and the results of connecting the known elements via the known method would be predictable to one of ordinary skill in the art.
In addition to the teachings of Chan, Perkins teaches, in the same field of endeavor, an ocular surgical handpiece for phacoemulsification comprising an irrigation tube (tubing 104) (paragraphs [0018] and [0028 – 0029]) comprising a compliant tube section (Examiner’s note: as recited in paragraph [0029] the irrigation tube 104 is made out of a compliant material) so that when a vacuum surge occurs (e.g., typically after a piece of cataract tissue occluding a phacoemulsification needle tip has cleared), there is sufficient irrigation fluid supply to prevent eye chamber collapse, which would be very harmful to the patient (paragraph [0021]). Therefore, Perkins teaches, makes obvious, having (at least a portion of) the irrigation tube of a phacoemulsification device be made out of a more compliant material.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the irrigation tube of Rockley to incorporate a more compliant section integrally formed with the irrigation tube, as taught by Chan and based off the teachings of Perkins, for the purpose of making sure that when a vacuum surge occurs (e.g., typically after a piece of cataract tissue occluding a phacoemulsification needle tip has cleared), there is sufficient irrigation fluid supply to prevent eye chamber collapse, which would be very harmful to the patient (paragraph [0021] – Perkins). It should be understood that the modification above is such that the complaint portion of Chan is brought into the system of Rockley for the reasons taught by Perkins; the Examiner is not modifying the entire irrigation tube to be compliant. Furthermore:
With respect to the location of the compliant section discussed in limitation (i), it has been held that choosing any solution from a finite number of solutions to obtain a predictable result is well within the purview of ordinary skill in the art. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S., 82 USPQ2d 1385 (2007). It can be seen that there are only a finite number of positions for the integrated compliant tube section to be placed along the irrigation tube, the integrated compliant tube section can be placed: at / near the proximal end, in the middle section, or at / near the distal section (i.e., the section closest to the phacoemulsification handpiece – as claimed). Therefore, it would have been obvious to one of ordinary skill in the art to have the compliant tube section be at an end near the phacoemulsification handpiece as it only involves choosing a location from a finite number of locations, and one of ordinary skill in the art would have a reasonable expectation of success in choosing the location to be at or near the end of the phacoemulsification handpiece, and the results of the modification would have been predictable and resulted in the modified device being able to function as intended to prevent eye chamber collapse.
With respect to (ii), there is no evidence of record that establishes that changing the length of the compliant section (taught by Chan) to have a length be within the claimed range (i.e., less than 1% of the length of the irrigation tube) would result in a difference in function of the modified device. Further, a person having ordinary skill in the art, being faced with modifying length of either the irrigation tube of Rockley or the length of compliant section of Chan, such that the compliant section is less than 1% in length of the length of irrigation tube, 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 relative length. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the relative “may” be within the claimed range, (e.g., less than 10% or less than 1%, specification at paragraph [0031]) and thus there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the relative length of the compliant section to be less than 1% of the length of the irrigation tube as an obvious matter of design choice within the skill of the art.
With respect to the limitation “configured to absorb intraocular pressure (IOP) fluctuations of the eye during irrigation and aspiration” in (iv), it should be understood that the limitation is an intended use limitation, which only requires the structure of the prior to be capable of performing the intended use; and with the combination above, the modified device of Rockley is structurally the same as the claimed device, and because the modified device is structurally the same as the claimed device then it can be said that the modified device of Rockley is configured to / capable of performing the function as claimed (i.e., to absorb the intraocular pressure fluctuations of the eye during irrigation and aspiration).
However the combination of Rockley and Chan is silent regarding (vi) has a shore value of 70 – 80, and is more compliant than the material of the irrigation tube. With respect to the limitation “more complaint than the irrigation tube” in (vi), it should be understood that the modification above makes obvious wherein the compliant tube section is more compliant that the rest of the irrigation tube in absorbing intraocular pressure (IOP) fluctuations of the eye during irrigation and aspiration because Rockley does not disclose the irrigation tube expanding during said fluctuations as opposed to the complaint tube section, taught by Chan, which does expand substantially more than the rest of the tubing when the pressure fluctuates upwards. Therefore, it would be obvious for modified device to encompass wherein the complaint tube section, taught by Chan, is more complaint than the rest of the irrigation tube. However, the combination of Rockley and Chan is silent regarding the specific materials of each section.
As to (vi), Dimalanta, Jr teaches an ophthalmologic surgical tubing comprising high compliant sections (which equates to the compliant section of Chan) and low compliant sections (which equates the irrigation tubing of Rockley), wherein the high compliant sections are made up of a more compliant material than the low complaint sections (paragraph [0029]) and is made up of a material with a shore value of 70 (paragraph [0033]). Additionally, Dimalanta teaches in paragraph [0026], wherein the low compliant sections (which equates the irrigation tubing of Rockley) has a larger wall thickness than the high compliant sections (which equates to the compliant section of Chan) in order to create the respective complaint characteristics of each section (i.e., making the tube section thicker to create / impart lower compliance and making the tube section thinner to create / impart higher compliance).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the compliant tube section of Rockley in view of Chan to comprises a material with a shore value of 70 as a material with a shore value of 70 is known in the art to be used for high compliant (i.e., more compliant) material sections, and one of ordinary skill in the art would have a reasonable expectation of success in making a high compliant (i.e., more compliant) section out of a material with a shore value of 70 and with a lower wall thickness (compared to the lower complaint sections), and the results would have been predictable and the device’s complaint section(s) would be operable to expand with any increased pressure as intended. Additionally, although already stated above, it would be obvious for the rest of the irrigation tube of Rockley to be made up a material (i.e., a low complaint material) that is different from the complaint tube section material (i.e., a high compliant material) since Rockley does not disclose or teach wherein the irrigation tube expands with pressure fluctuations in the same manner that the complaint tube section of Chan does; moreover, it would be obvious and well within the purview of one of ordinary skill in the art, based on the teachings of Dimalanta, to make the non-compliant portion of the irrigation tube out of a non-compliant material (i.e., a low compliant material) with a thinner wall thickness for the purpose of allowing the noncompliant section to remain rigid as intended.
However, the combination of Rockley, Chan, and Dimalanta is silent regarding (vii) wherein the irrigation tube has a wall thickness between 0.7 and 1.0mm and each integrated compliant tube section has a wall thickness between 0.35 and 0.5mm.
As to (vii), as discussed above it would have been obvious to modify each of the at least one integrated tube sections (higher compliant sections) to have thinner wall thickness compared to the rest of the irrigation tube (the lower complaint section). Additionally, 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 device of Rockley, Chan, and Dimalanta to have the irrigation tube have a wall thickness between a maximum proximal diameter of between 0.7 and 1.0mm and each integrated compliant tube section has a wall thickness between 0.35 and 0.5mm 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 device of Rockley in view of Chan and Dimalanta would not operate differently with the claimed wall thicknesses since the wall thickness is a characteristic of compliance, wherein as the thickness decreases the compliance increases, and the integrated complaint tube sections of Rockley in view of Chan and Dimalanta are intended to have a higher compliance relative to the rest of the irrigation tube portions. Further, it appears that applicant places no criticality on the ranges claimed, indicating simply that the wall thicknesses “might” be within the claimed ranges (specification pp. [0034]).
Regarding claim 3, the limitation of claim 3 is considered to be product by process claim limitations (only limited to structure of implied step) “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). In the instant case, producing the balloon by blow molding of said irrigation tube imparts no structural differences between the instant application and the prior art as both result in an irrigation tube with non-compliant and compliant sections of the tube; additionally, forming the balloon of the prior art in the manner claimed would result in the desired structure of the prior art, i.e. a compliant balloon section integrally formed with a [non-compliant / less compliant] tube section. Therefore the product of the prior art encompasses the product — by — process as claimed.
Regarding claim 4, as discussed above, it would have been obvious to modify the irrigation line of Rockley to incorporate a compliant tube section in view of Chan, Perkins, and Dimalanta, Jr. Additionally, although the combination is silent regarding (i) wherein said section diameter is 10 - 50% larger than said irrigation tube diameter, there is no evidence of record that establishes that changing the diameter of the compliant section (taught by Chan) to have a diameter be within the claimed range (i.e., 10 - 50% of the diameter of the irrigation tube) would result in a difference in function of the modified device. Further, a person having ordinary skill in the art, being faced with modifying length of either the irrigation tube of Rockley or the length of compliant section of Chan, such that the compliant section has a diameter that is 10 - 50% larger than the diameter of irrigation tube, 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 relative diameter. Lastly, Applicant has not disclosed that the claimed range solves any stated problem, indicating that the relative size “may” be within the claimed range, (e.g., larger than 10% or 2 to 5 times the size of the tube, specification at paragraphs [0007] and [0032]) and thus there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the relative diameter of the compliant section to be 10% - 50% of the diameter of the irrigation tube as an obvious matter of design choice within the skill of the art
Regarding claim 11, as discussed above, it would have been obvious to modify the irrigation line of Rockley to incorporate a compliant tube section in view of Chan, Perkins, and Dimalanta, Jr. Additionally, although the combination is silent regarding (i) wherein said compliant tube section has a length of 3 - 10cm long, there is no evidence of record that establishes that changing the length of the compliant section (taught by Chan) to have a length be within the claimed range (i.e., 3 – 10 cm) would result in a difference in function of the modified device. Further, a person having ordinary skill in the art, being faced with modifying the length of compliant section of the modified device, 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 length. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the length “may” be within the claimed range, (e.g., 3 – 10cm, specification at paragraph [0039]) and thus there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the length of the compliant section to be 3-10 cm as an obvious matter of design choice within the skill of the art
Regarding claims 5, 6, 13, 14, and 16, Rockley discloses irrigation tube (line 36) for a phacoemulsification probe (ocular handpiece 100) used for aspirating a cataract from an eye (abstract, paragraphs [0002 – 0004], [0063], [0065], and Fig. 1), the irrigation tube comprising:
a long tube portion (line 36) (paragraph [0065] and Fig. 1).
However, Rockley is silent regarding (i) [claims 5 and 13] at least one integrated compliant tube section / a compliant tube section at an end of said long tube portion near its connection to said phacoemulsification probe, (ii) [claims 5 and 13] wherein the at least one compliant tube section / compliant tube section is less than 1 % of a length of said irrigation tube, (iii) has a section diameter larger than a tube diameter of said irrigation tube, (iv) [claims 5, 13, 14, and 16] is more compliant in absorbing intraocular pressure (IOP) fluctuations of the eye during irrigation and aspiration, is made up of a compliant material / silicone, and (v) [claim 6] wherein said at least one integrated compliant tube section is at least one balloon integrally formed in said irrigation tube.
As to (i) – (v), Chan teaches an irrigation tube (inlet and outlet tubing 174 / 176; which equates to the irrigation tube of Rockley) (abstract, paragraphs [0053 – 0054], and Fig. 12) comprising a long tube portion (inlet and outlet tubing 174 / 176, respectively) (paragraphs [0053 – 0054] and Fig. 12) and at least one integrated compliant tube section (dampener 170) comprising at least one balloon (Examiner’s note: a balloon is defined as an inflatable structure made up of plastic, and, as discussed in paragraphs [0053 – 0055], the dampener 170 is made up of silicone and is inflatable. Therefore, the dampener 170 is considered to be a balloon) connectable to an end of said long tube portion (shown in Fig. 12) for the purpose of dampening pressure fluctuations of the pulsatile flow and to smoothen the pulsatile fluid flow (paragraphs [0007 – 0008]), wherein said compliant tube section has a section diameter larger than a tube diameter of said irrigation tube (shown in Fig. 12) (Examiner’s note: in the expanded state, shown in Fig. 12, the section diameter is larger than the tube diameter. Additionally, Chan recites in paragraph [0054] wherein the dampener 170 is similar to the dampener 160, and in paragraph [0053], recites, wherein the walls of the dampener expand due to the pressure spike; therefore, the walls of the dampener 170 would also expand, and since paragraph [0054] states that the diameter of the dampener 170 is substantially equal to the tube diameter, then when the dampener 170 is expanded the diameter will be greater than the tube diameter), and made up of a compliant material / silicone (paragraph [0053 – 0055]). Additionally, it is noted that Chan further teaches, in a separate embodiment, wherein the compliant tube section (dampener 140; which equates to the dampener 170) is integrally formed with the infusion line (i.e., the irrigation line) (paragraph [0050]), therefore, Chan teaches it is well within the purview of, and would be obvious to, one of ordinary skill in the art to integrally form the compliant tube section with the infusion line (i.e., the irrigation line) as integrally forming a compliant section with the infusion line is a known method of connecting known elements (i.e., a compliant tube section and an irrigation line), and the results of connecting the known elements via the known method would be predictable to one of ordinary skill in the art.
In addition to the teachings of Chan, Perkins teaches, in the same field of endeavor, an ocular surgical handpiece for phacoemulsification comprising an irrigation tube (tubing 104) (paragraphs [0018] and [0028 – 0029]) comprising a compliant tube section (Examiner’s note: as recited in paragraph [0029] the irrigation tube 104 is made out of compliant material, the whole tube is a compliant section) so that when a vacuum surge occurs (e.g., typically after a piece of cataract tissue occluding a phacoemulsification needle tip has cleared), there is sufficient irrigation fluid supply to prevent eye chamber collapse, which would be very harmful to the patient (paragraph [0021]). Therefore, Perkins teaches, makes obvious, having at least a portion of the irrigation tube of a phacoemulsification device be made out of a more compliant material.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the irrigation tube of Rockley to incorporate a more compliant section integrally formed with the irrigation tube, as taught by Chan and based off the teachings of Perkins, for the purpose of making sure that when a vacuum surge occurs (e.g., typically after a piece of cataract tissue occluding a phacoemulsification needle tip has cleared), there is sufficient irrigation fluid supply to prevent eye chamber collapse, which would be very harmful to the patient (paragraph [0021] – Perkins). It should be understood that the modification above is such that the complaint portion of Chan is brought into the system of Rockley for the reasons taught by Perkins; the Examiner is not modifying the entire irrigation tube to be compliant. Furthermore:
With respect to the location of the compliant section discussed in limitation (i), it has been held that choosing any solution from a finite number of solutions to obtain a predictable result is well within the purview of ordinary skill in the art. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S., 82 USPQ2d 1385 (2007). It can be seen that there are only a finite number of positions for the integrated compliant tube section to be placed along the irrigation tube, the integrated compliant tube section can be placed: at / near the proximal end, in the middle section, or at / near the distal section (i.e., the section closest to the phacoemulsification handpiece – as claimed). Therefore, it would have been obvious to one of ordinary skill in the art to have the compliant tube section be at an end near the phacoemulsification handpiece as it only involves choosing a location from a finite number of locations, and one of ordinary skill in the art would have a reasonable expectation of success in choosing the location to be at or near the end of the phacoemulsification handpiece, and the results of the modification would have been predictable and resulted in the modified device being able to function as intended to prevent eye chamber collapse.
With respect to (ii), there is no evidence of record that establishes that changing the length of the compliant section (taught by Chan) to have a length be within the claimed range (i.e., less than 1% of the length of the irrigation tube) would result in a difference in function of the modified device. Further, a person having ordinary skill in the art, being faced with modifying length of either the irrigation tube of Rockley or the length of compliant section of Chan, such that the compliant section is less than 1% in length of the length of irrigation tube, 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 relative length. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the relative “may” be within the claimed range, (e.g., less than 10% or less than 1%, specification at paragraph [0031]) and thus there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the relative length of the compliant section to be less than 1% of the length of the irrigation tube as an obvious matter of design choice within the skill of the art.
With respect to the limitation “configured to absorb intraocular pressure (IOP) fluctuations of the eye during irrigation and aspiration” in (iv), it should be understood that the limitation is an intended use limitation, which only requires the structure of the prior to be capable of performing the intended use; and with the combination above, the modified device of Rockley is structurally the same as the claimed device, and because the modified device is structurally the same as the claimed device then it can be said that the modified device of Rockley is configured to / capable of performing the function as claimed (i.e., to absorb the intraocular pressure fluctuations of the eye during irrigation and aspiration).
However the combination of Rockley and Chan is silent regarding (v) has a shore value of 70 – 80, and is more compliant than the material of the irrigation tube. With respect to the limitation “more complaint than the irrigation tube” in (v), it should be understood that the modification above makes obvious wherein the compliant tube section is more compliant that the rest of the irrigation tube in absorbing intraocular pressure (IOP) fluctuations of the eye during irrigation and aspiration because Rockley does not disclose the irrigation tube expanding during said fluctuations as opposed to the complaint tube section, taught by Chan, which does expand substantially more than the rest of the tubing when the pressure fluctuates upwards. Therefore, it would be obvious for modified device to encompass wherein the complaint tube section, taught by Chan, is more complaint than the rest of the irrigation tube. However, the combination of Rockley and Chan is silent regarding the specific materials of each section.
As to (v), Dimalanta, Jr teaches an ophthalmologic surgical tubing comprising high compliant sections (which equates to the compliant section of Chan) and low compliant sections (which equates the irrigation tubing of Rockley), wherein the high compliant sections are made up of a more compliant material than the low complaint sections (paragraph [0029]) and is made up of a material with a shore value of 70 (paragraph [0033]). Additionally, Dimalanta teaches in paragraph [0026], wherein the low compliant sections (which equates the irrigation tubing of Rockley) has a larger wall thickness than the high compliant sections (which equates to the compliant section of Chan) in order to create the respective complaint characteristics of each section (i.e., making the tube section thicker to create / impart lower compliance and making the tube section thinner to create / impart higher compliance).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the compliant tube section of Rockley in view of Chan to comprises a material with a shore value of 70 as a material with a shore value of 70 is known in the art to be used for high compliant (i.e., more compliant) material sections, and one of ordinary skill in the art would have a reasonable expectation of success in making a high compliant (i.e., more compliant) section out of a material with a shore value of 70 and with a lower wall thickness (compared to the lower complaint sections), and the results would have been predictable and the device’s complaint section(s) would be operable to expand with any increased pressure as intended. Additionally, although already stated above, it would be obvious for the rest of the irrigation tube of Rockley to be made up a material (i.e., a low complaint material) that is different from the complaint tube section material (i.e., a high compliant material) since Rockley does not disclose or teach wherein the irrigation tube expands with pressure fluctuations in the same manner that the complaint tube section of Chan does; moreover, it would be obvious and well within the purview of one of ordinary skill in the art, based on the teachings of Dimalanta, to make the non-compliant portion of the irrigation tube out of a non-compliant material (i.e., a low compliant material) with a thinner wall thickness for the purpose of allowing the noncompliant section to remain rigid as intended.
However, the combination of Rockley, Chan, and Dimalanta is silent regarding (vi) wherein the irrigation tube has a wall thickness between 0.7 and 1.0mm and each integrated compliant tube section has a wall thickness between 0.35 and 0.5mm.
As to (vi), as discussed above it would have been obvious to modify each of the at least one integrated tube sections (higher compliant sections) to have thinner wall thickness compared to the rest of the irrigation tube (the lower complaint section). Additionally, 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 device of Rockley, Chan, and Dimalanta to have the irrigation tube have a wall thickness between a maximum proximal diameter of between 0.7 and 1.0mm and each integrated compliant tube section has a wall thickness between 0.35 and 0.5mm 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 device of Rockley in view of Chan and Dimalanta would not operate differently with the claimed wall thicknesses since the wall thickness is a characteristic of compliance, wherein as the thickness decreases the compliance increases, and the integrated complaint tube sections of Rockley in view of Chan and Dimalanta are intended to have a higher compliance relative to the rest of the irrigation tube portions. Further, it appears that applicant places no criticality on the ranges claimed, indicating simply that the wall thicknesses “might” be within the claimed ranges (specification pp. [0034]).
Regarding claim 7, the limitation of claim 7 is considered to be product by process claim limitations (only limited to structure of implied step) “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). In the instant case, producing the balloon by blow molding of said irrigation tube imparts no structural differences between the instant application and the prior art as both result in an irrigation tube with non-compliant and compliant sections of the tube; additionally, forming the balloon of the prior art in the manner claimed would result in the desired structure of the prior art, i.e. a compliant balloon section integrally formed with a [non-compliant / less compliant] tube section. Therefore the product of the prior art encompasses the product — by — process as claimed.
Regarding claim 8, as discussed above, it would have been obvious to modify the irrigation line of Rockley to incorporate a compliant tube section in view of Chan, Perkins, and Dimalanta, Jr. Additionally, although the combination is silent regarding (i) wherein said section diameter is 10 - 50% larger than said tube diameter, there is no evidence of record that establishes that changing the diameter of the compliant section (taught by Chan) to have a diameter be within the claimed range (i.e., 10 - 50% of the diameter of the irrigation tube) would result in a difference in function of the modified device. Further, a person having ordinary skill in the art, being faced with modifying length of either the irrigation tube of Rockley or the length of compliant section of Chan, such that the compliant section has a diameter that is 10 - 50% larger than the diameter of irrigation tube, 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 relative diameter. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the relative diameter “may” be within the claimed range, (e.g., larger than 10% or 2 to 5 times the size of the tube, specification at paragraphs [0007] and [0032]) and thus there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the relative diameter of the compliant section to be 10% - 50% of the diameter of the irrigation tube as an obvious matter of design choice within the skill of the art.
Regarding claim 15, as discussed above, it would have been obvious to modify the irrigation line of Rockley to incorporate a compliant tube section in view of Chan, Perkins, and Dimalanta, Jr. Additionally, although the combination is silent regarding (i) wherein said compliant tube section has a length of 3 - 10cm long, there is no evidence of record that establishes that changing the length of the compliant section (taught by Chan) to have a length be within the claimed range (i.e., 3 – 10 cm) would result in a difference in function of the modified device. Further, a person having ordinary skill in the art, being faced with modifying length of compliant section of the modified device, 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 length. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the length “may” be within the claimed range, (e.g., 3 – 10cm, specification at paragraph [0039]) and thus there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the length of the compliant section to be 3-10 cm as an obvious matter of design choice within the skill of the art
Response to Arguments
Applicant's arguments filed 02/03/2026 directed the rejections of claims 1, 5, 9, and 13 under Rockley in view of Chan, Perkins, and Dimalanta, have been fully considered but they are not persuasive. More specifically:
Regarding the argument that “Dimalanta, is silent, however, on specific dimensions of the high and low compliant tubing sections. Perkins is directed to irrigation/aspiration tubing for ophthalmic surgery. Perkins is silent regarding compliant tubing sections”, the Examiner acknowledges that Dimalanta does not give a specific range to the wall thicknesses, however, as stated in Applicant’s argument, Dimalanta does disclose the inverse relationship between the wall thickness and the compliance of the tube, such that the changing the wall thickness changes the compliance of the tube. Furthermore, Applicant has not provided criticality for the claimed ranges, such that the claimed ranges produce unexpected results or provided evidence that the modified device given the claimed ranges would perform differently than intended. Therefore, it would have been obvious and well within the purview of one having ordinary skill in the art before the effective filing date of the claimed invention to modify have the relative wall thicknesses for the reasons stated in the rejection above. Thus Applicant’s arguments are not persuasive. Lastly, the Examiner notes that the arguments of the attorney cannot take place of evidence. See In Re Schulze, 346, F.2d 600,602, 145 USPQ 716, 718 (CCPA 1965).
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.
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/Andrew Restaino/Primary Examiner, Art Unit 3771
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