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 .
Examiner’s Note
Claims 2 – 4, 6 – 8, 10 – 12, and 14 – 16 of the claims filed 10/21/2025 contain either language previously removed from the claims or amendments previously disclosed in the claims filed on 06/12/2025. Due to the issues listed above, the claims filed on 10/21/2025 are considered to be Non-Compliant and a PTOL-324 should be sent out. However, in an effort to expedite prosecution, the Examiner is choosing to forgo sending out a PTOL-324 Notice of Non-Compliance and to examine the claims as best understood by the Examiner. The Examiner suggests the newest claim sets contain up to date amendments in the future in order to avoid any delay in prosecution.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/21/2025 has been entered.
Response to Amendment
This Office action is in response to the applicant’s communication filed 10/21/2025.
Status of the claims:
Claims 1 – 16 are pending in the application.
Claims 1, 4 – 9, 12, 13, and 16 are amended.
Claim Objections
The objections to claims 1 – 8 in the previous action dated 07/22/2025 have been withdrawn in light of the Applicant’s amendments filed 10/21/2025. Specifically, the objection to claims 1, 5, 9, 12, 13, and 16, regarding the phrase “and is more compliant absorbing intraocular pressure (IOP) fluctuations of the eye during irrigation and aspiration”, have withdrawn as the appropriate corrections have been made.
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 1 – 3, 5 – 7, and 9 – 16 under U.S.C 35 112(b) regarding indefiniteness, recited in the previous action dated 07/22/2025 have been withdrawn in light of the Applicant’s amendments filed 10/21/2025. Specifically, the rejections of claims 1, 5, 9, and 13, regarding the phrase “is more compliant”, and the rejection of claims 2 – 8, 10 – 12, and 14 – 16 for being dependent on an indefinite claim have been withdrawn. However, the rejection of claims 4 and 8 have been maintained, and repeated below, as the claims are still unclear for the same reason as stated in the previous rejection.
Claims 4 and 8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 4 and 8, the phrase "said section diameter" renders the claim indefinite because it is unclear if Applicant is intending to further narrow the system such the claims require only one section diameter out of all of the section diameters of each of said at least one integrated compliant tube sections or if Applicant is intending for the claim to read “said section diameters of each of said at least one the at least one balloon” such that the section diameter of each of the at least one balloons has the claimed diameter. For the purpose of examination, the Examiner will read the claim to mean the latter. If Applicant is intending the latter, the Examiner suggests the line be amended to read “said section diameters of each of the at least one integrated balloons”. To for clarify, Claim 1 recites “each of said at least one integrated compliant tube section” giving a section diameter to each of the at least one integrated compliant tube sections, claim 2 then recites “the at least one integrated compliant tube section is at least one balloon”, so claim 2 requires each of the at least one balloons to have a section diameter. Claims 4 (and 8) recite “said section diameter” however there are multiple section diameters because each of the at least one balloons has a section diameter and it is unclear if Applicant is intending for “said section diameter” to mean only one or all of diameter sections.
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, (v) has a shore value of 70 – 80, and is more compliant than the material of the irrigation tube, and (vi) [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) – (iv) and (vi), 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).
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]).
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 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) for the purpose of allowing the noncompliant section to remain rigid as intended.
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, (v) has a shore value of 70 – 80, and is more compliant than the material of the long tube portion, and (vi) [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) – (iv) and (vi), 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).
With respect to the limitation “more complaint than the long tube portion” 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 / the long tube portion 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]).
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 the results would have been predictable and the device’s complaint section(s) would be operable to expand with 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) for the purpose of allowing the noncompliant section to remain rigid as intended.
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 10/20/2025, 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 (i) “Chan does not disclose, teach, or suggest each of said at least one integrated compliant tube section is more compliant absorbing intraocular pressure (IOP) fluctuations of the eye during irrigation and aspiration. Chan simply discloses a dampening element, which transforms a generally non-continuous or pulsatile flow of fluid within the infusion system into a generally smoother or less pulsatile fluid flow. Thus, the combination of Chan and Rockley fails to disclose the limitation above”, it should be understood that the Examiner does not rely on the teachings of Chan to teach the recited limitation. Additionally, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Moreover, the combination of Rockley and Chan is structurally similar to the claimed device and Applicant has not provided any evidence to suggest that the device of Rockley in view of Chan would not be capable of functioning as intended. Thus, the arguments above are not persuasive. The Examiner suggests adding structural features to further differentiate the claimed device from that of the prior art.
Regarding the argument that “It can be seen that Perkins teaches a irrigation tube may include a compliant material. Perkins, however, does not disclose or suggest “at least one integrated compliant tube section... has a section diameter larger than a tube diameter of said irrigation tube.”, “the irrigation tube 104 does not include an irrigation tube connectable to said phacoemulsification probe and having at least one integrated compliant tube section at an end of the irrigation tube near said phacoemulsification” , “Perkins does not disclose or suggest the “at least one integrated compliant tube section... [that] is more compliant in absorbing intraocular pressure (IOP) fluctuations of the eye during irrigation and aspiration compared to a portion of the irrigation tube not having the at least one integrated compliant tube section,” fails to cure the deficiencies in Rockley and Chan”, and “Perkins lacks both a teaching or suggestion that each of the at least one integrated compliant tube section “‘is less than 1% (or any percent less than 100%) of a length of said irrigation tube,” “has a section diameter larger than a tube diameter of said irrigation tube,” and “is more compliant in absorbing intraocular pressure (IOP) fluctuations of the eye during irrigation and aspiration.””, it should be understood that the Examiner is only relying upon Perkins to show that surges / changes in pressure in the IOP is a known issue, and a means for solving the problem by using a compliant wall section on the irrigation tube of a phacoemulsification device is a known means of solving the problem, and that it would be obvious, based on the known problem and the known solution, to one of ordinary skill in the art to apply the compliant section of Chan to the phacoemulsification device of Rockley to solve the known problem that occurs during the phacoemulsification procedure. Additionally, it should be understood that the limitation “at least one integrated compliant tube section... is more compliant in absorbing intraocular pressure (IOP) fluctuations of the eye during irrigation and aspiration compared to a portion of the irrigation tube not having the at least one integrated compliant tube section,” is an intended use limitation which requires only that the structure of the prior art be capable of functioning in the manner claimed; with that said, the structure of the device of Rockley modified by Chan in view of Perkins is structurally the similar to the claimed device, and there is no evidence that suggests that the modified device would not function in the manner claimed. Therefore, it is said that the device of Rockley in view of Chan and Perkins is configured to function in the manner claimed. Thus, the arguments above are not persuasive. The Examiner suggests adding structural features to further differentiate the claimed device from that of the prior art.
Regarding the argument that “Dimalanta simply discloses tubes with different levels of compliance. For example, maneuverability may call for tubes of relatively high compliance while navigability may call for tubes of relatively low compliance. Dimalanta fails to cure the above identified deficiencies in Rockley, Chan, and Perkins.”, it should be understood that the Examiner is only relying upon Dimalanta to teach that it is obvious for a compliant tube section be made out of a complaint material with the claimed shore value. Therefore, the argument is not persuasive.
Regarding the arguments directed to the percent length of the complaint tube sections of the device, the Examiner notes that Applicant has not disclosed or otherwise provided criticality for the claimed range of the percent length of the compliant tube sections relative to the length of the irrigation tube. Therefore, due to the lack of criticality, it would be obvious to one of ordinary skill in the art to have the modified device with claimed relative lengths as one of ordinary skill in the art 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 lengths.
Regarding the argument that “Applicant understands the point regarding the capability of the modified device of Rockley. However, the statement that the modified device of Rockley is structurally the same as the claimed device is simply not supported by the teaching of Rockley, Chan, and Perkins; with or without Dimalanta.” and “As explained above, Perkins fails to disclose at least one integrated compliant tube section that is more compliant in absorbing IOP fluctuations of the eye during irrigation and aspiration. This feature is only found in the features recited in Applicant’s claims, and the modified device of Rockley is not structurally the same as the device recited in applicant’s claims”, as stated above, the modification only relies upon Perkins for teaching the motivation to combine the compliant tube section of Chan onto the irrigation tube of Rockley, furthermore, Applicant has not stated how the modified device of Rockley with the compliant tube section of Chan comprising the compliant material with a shore value of 70, taught by Dimalanta, is structurally different than the claimed device. Therefore, because there are no structural differences between the claimed device and the device of the prior art, it is said that the device of the prior art is capable of operating in the manner claimed to absorb intraocular pressure fluctuations of the eye during irrigation and aspiration in the same manner that the claimed device is configured to. The Examiner suggests adding structural features to further differentiate the claimed device from that of the prior art.
Conclusion
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/Andrew Restaino/Primary Examiner, Art Unit 3771