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 .
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered:
Heriot WJ Intravitreal gas and tPA: an outpatient procedure for submacular hemorrhage. Paper presented at: American Academy of Ophthalmology Annual Vitreoretinal, Update October 1996 Chicago, IL (page 17)
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “fan-shaped” (claim 5, line 3), “a gas pressure sensor” (claim 14, line 1), “a computer system”, “a computer monitor”, “a dial and haptic feedback display” (claim 18, lines 2-3), a gas compressor, a medical-grade air filter (claim 19, lines 1-2), “a valve or regulated connection” (claim 20, lines 1-2), “the valve or regulator” (claim 21, line 1) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because:
In line 4, “sub-retinal hemorrhage” should be changed to “the sub-retinal hemorrhage”
In lines 4-5, “the macula” should be changed to “a macula”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1, 5-6, 8, 11-13, 16, 19, 21-22, and 26 are objected to because of the following informalities:
In regards to claim 1, line 3, “one” should be changed to “one longitudinal axis”.
In regards to claim 1, line 5, “distal end” should be changed to “a distal end”.
In regards to claim 5, lines 2-3, “a spatulated, fan-shaped, round, prolate round, or rectangular shape” should be changed to “a spatulated shape, a fan-shaped shape, a round shape, a prolate round shape, or a rectangular shape”.
In regards to claim 6, line 2, “a prolate round shape” should be changed to “a prolate round shape”.
In regards to claim 8, line 1, “where” should be changed to “wherein”.
In regards to claim 11, line 4, “the flow” should be changed to “a flow”.
In regards to claim 12, line 2, “gas” should be changed to “the gas”.
In regards to claim 13, line 2, “gas” should be changed to “the gas”.
In regards to claim 16, line 2, “the amount” should be changed to “an amount”.
In regards to claim 19, line 2, “the medical-grade gas or air” should be changed to “the air or medical grade gas”.
In regards to claim 21, line 2, “the medical-grade gas or air” should be changed to “the air or medical grade gas”.
In regards to claim 22, line 1, “gas flow” should be changed to “the flow of the gas”.
In regards to claim 22, line 2, “a pulsed or continuous modes” should be changed to “a pulsed mode or a continuous mode”.
In regards to claim 26, lines 1-2, “the eye” should be changed to “an eye”.
In regards to claim 26, line 3, “a gas cannula” should be changed to “the gas cannula”.
In regards to claim 26, line 4, “a sub-retinal hemorrhage” should be changed to “the sub-retinal hemorrhage”.
In regards to claim 26, line 4, “a subject” should be changed to “the subject”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-31 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.
In regards to claim 1, line 10 recites “dispensed air”. Claim 1, line 7 recites “pressurized air”. It is unclear whether the two terms refer to the same component or to different components. Claims 2-31 are rejected by virtue of being dependent upon claim 1.
In regards to claim 5, line 1 recites “the one or more distal openings”. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 5 depends upon claim 1. Claim 1, line 6 recites “one or more openings”. It is unclear whether the two terms refer to the same component or to different components. Claim 6 is rejected by virtue of being dependent upon claim 5. Claim 6 also recites the unclear term “the one or more distal openings”.
In regards to claim 5, line 2 recites “a cross-sectional profile”. Claim 5 depends upon claim 1. Claim 1, line 9 recites “a profile”. If “one or more openings” of claim 1 and “the one or more distal openings” of claim 5 are the same component, It is unclear whether “a profile” and “a cross-sectional profile” refer to the same component or to different components. Claim 6 is rejected by virtue of being dependent upon claim 5.
In regards to claim 7, line 1 recites “the one or more distal openings”. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 7 depends upon claim 1. Claim 1, line 6 recites “one or more openings”. It is unclear whether the two terms refer to the same component or to different components.
In regards to claim 8, lines 1-2 recite “a longitudinal axis”. Claim 8 depends upon claim 1. Claim 1, line 3 recites “one or a plurality of longitudinal axes”. It is unclear whether the two terms refer to the same component or to different components.
In regards to claim 9, lines 1-2 recite “two or more longitudinal axes”. Claim 9 depends upon claim 1. Claim 1, line 3 recites “one or a plurality of longitudinal axes”. It is unclear whether the two terms refer to the same component or to different components. Claim 10 is rejected by virtue of being dependent upon claim 9.
In regards to claim 10, lines 1-2 recite “two longitudinal axes”. Claim 10 depends upon claim 9. Claim 9, lines 1-2 recite “two or more longitudinal axes”. Claim 9 depends upon claim 1. Claim 1, line 3 recites “one or a plurality of longitudinal axes”. It is unclear whether the three terms refer to the same component or to different components.
In regards to claim 10, line 3 recites “each axis”. Claim 10, lines 1-2 recite “two longitudinal axes”. Claim 10 depends upon claim 9. Claim 9, lines 1-2 recite “two or more longitudinal axes”. Claim 9 depends upon claim 1. Claim 1, line 3 recites “one or a plurality of longitudinal axes”. It is unclear which prior components are being referred to by “each axis”.
In regards to claim 11, line 8 recites “pressured gas”. Claim 11 depends upon claim 1. Claim 1, line 7 recites “pressurized… medical grade gas”. It is unclear whether the two terms refer to the same component or to different components. Claims 12-25 are rejected by virtue of being dependent upon claim 11.
In regards to claim 12, lines 2-3 recite “the lumen” of the handpiece. There is insufficient antecedent basis for this limitation in the claim.
In regards to claim 15, line 1 recites “the gas source controller”. There is insufficient antecedent basis for this limitation in the claim. Claim 16 is rejected by virtue of being dependent upon claim 15.
In regards to claim 16, line 2 recites “the gas pressure”. There is insufficient antecedent basis for this limitation in the claim.
In regards to claim 17, line 1 recites “the gas pressure”. There is insufficient antecedent basis for this limitation in the claim.
In regards to claim 18, lines 3-4 recite “the gas pressure”. There is insufficient antecedent basis for this limitation in the claim.
In regards to claim 21, line 1 recites “the gas pressure”. There is insufficient antecedent basis for this limitation in the claim.
In regards to claim 25, line 1 recites “the square wave pattern”. There is insufficient antecedent basis for this limitation in the claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6, 8-9, and 26-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 12-13, 17-18, and 23-28 of copending Application No. 18/374,304 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications at least claim a gas cannula (a gas pressure modulator handpiece), a continuous wall (a wall), one or a plurality of longitudinal axes (a longitudinal axis), a proximal end, distal end, and one or more openings.
The table below shows application claims 1-6, 8-9, and 26-31 corresponding to claims 1-6, 12-13, 17-18, and 23-28 of copending Application No. 18/374,304:
Application claims
Application No. 18/374,304 claims
1
1
2
2
3
3
4
4
5
5
6
6
8
12/13/17
9
12/13/18
26
23
27
24
28
25
29
26
30
27
31
28
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4-6, 8-11, 17, and 19-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Saperstein et al (US 5,919,158).
In regards to claim 1, Saperstein et al teaches a gas cannula (Figures 1-6, infusion cannula 40) comprising:
a continuous wall (42) surrounding an open lumen (Figure 4)
one or a plurality of longitudinal axes (line 4--4) along the open lumen (Figure 3)
a proximal end (42a)
distal end (41)
wherein the distal end comprises one or more openings (46) configured to allow for pressurized air or medical grade gas (50) to propagate and be ejected from said open lumen to said distal end (Figures 1-2, 4)
wherein the one or more openings comprise a profile configured to propagate and eject dispensed air from said distal end in a laminar flow pattern (Figures 1-2, 4)
In regards to claim 2, Saperstein et al teaches wherein the laminar flow pattern is an air knife (Figures 1-2, 4).
In regards to claim 4, Saperstein et al teaches wherein the propagated and ejected gas is propagated in a continuous or pulsed manner (Figures 1-2, 4).
In regards to claim 5, Saperstein et al teaches wherein the one or more distal openings independently comprise a cross-sectional profile selected from a spatulated, fan-shaped, round, prolate round, or rectangular shape (Figures 3-4).
In regards to claim 6, Saperstein et al teaches wherein the one or more distal openings comprise a prolate round shape (Figure 4)(Figure 7).
In regards to claim 8, Saperstein et al teaches where the gas cannula comprises a longitudinal axis (line 11--11) which is curved (Figures 10-11).
In regards to claim 9, Saperstein et al teaches wherein the gas cannula comprises two or more longitudinal axes (line 11--11) such that the gas cannula is bent (Figures 10-11).
In regards to claim 10, Saperstein et al teaches wherein the gas cannula comprises two longitudinal axes (line 11--11) which are angled at an angle of about 135 to about 165 degrees in relation to each axis (Figure 11).
In regards to claim 11, Saperstein et al teaches a surgical system (Figures 1-6), comprising:
the gas cannula (40) of claim 1
a handpiece (48) coupled to a pressured gas source (column 3, lines 56-61)
wherein the handpiece is configured to selectively control the flow of the pressurized gas into the open lumen of said gas cannula (Figures 3-4)(column 3, lines 56-61)
wherein the handpiece is connected to the gas cannula (Figures 1-4)
a gas controller unit (pressure controls… pressure controller) connected to the proximal end of said gas cannula (column 3, lines 56-63)
wherein the gas controller unit presents pressured gas to the handpiece (Figures 3-4)(column 3, lines 56-63)
In regards to claim 17, Saperstein et al teaches wherein the gas pressure ranges from 0.1 to 20 psi (about 35 mm Hg) (column 7, lines 12-13).
In regards to claim 19, Saperstein et al teaches a gas compressor (temperature controller and the moisture controller comprise a compressor-based refrigeration device) and a medical-grade air filter (120) to produce the medical-grade gas or air at a selected gas pressure (Figure 13)(column 10, lines 9-11).
In regards to claim 20, Saperstein et al teaches a valved or regulated connection (appropriate pressure controls) to a pressurized medical gas tank (column 3, lines 56-59).
In regards to claim 21, Saperstein et al teaches wherein the valve or regulator presents the medical-grade gas or air to the handpiece at a selected gas pressure (column 3, lines 56-59).
In regards to claim 22, Saperstein et al teaches wherein the handpiece presents gas flow in a pulsed or continuous modes (Figures 1-2, 4).
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.
Claims 3, 7, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Saperstein et al, as applied to claim 1 above, and further in view of Charles et al (US 11,033,427).
In regards to claim 3, Saperstein et al is silent about wherein the open lumen has a longitudinal diameter ranging from 14-31 gauge. Charles et al teaches a gas cannula (Figures 1-3A, cannula 12) wherein an open lumen (33) has a longitudinal diameter of about 20 to about 27 gauge (column 6, lines 49-50), which is in the claimed range of 14-31 gauge. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the open lumen, of the cannula of Saperstein et al, to have a longitudinal diameter of about 20 to about 27 gauge, as taught by Charles et al, which is in the claimed range of 14-31 gauge, as such will allow for vitreoretinal surgery in which the cannula may be inserted into the eye behind the retina, such as for draining subretinal fluid (Figure 2)(column 4, lines 58-60).
In regards to claim 7, Saperstein et al is silent about wherein the one or more distal openings comprise a silicone tip. Charles et al teaches a gas cannula (Figures 1-3A, cannula 12) wherein one or more distal openings (32, 34a-34d) comprise a silicone tip (column 8, lines 12-14). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the one or more distal openings, of the cannula of Saperstein et al, to comprise a silicone tip, as taught by Charles et al, as such as a friction reducing material will avoid adherence to the retina, retinal pigment epithelium, or the choroid thereto (column 8, lines 12-16).
In regards to claim 28, Saperstein et al teaches a kit (Figures 1-6) comprising:
the gas cannula (40) of claim 1
Saperstein et al is silent about a therapeutic agent. Charles et al teaches a kit (Figures 1-3A) comprising a therapeutic agent (drug formulation) (column 14, lines 6-8). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the kit, of Saperstein et al, with a therapeutic agent, as taught by Charles et al, as such if desired (column 14, lines 6-8) will allow for diagnosing, preventing, treating, or curing diseases of the patient.
Claims 12-14 and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Saperstein et al, as applied to claims 11 and 22 above, and further in view of Uchida et al (US 2015/0238216).
In regards to claim 12, Saperstein et al is silent about wherein the handpiece comprises a toggle switch to control the flow of gas through the lumen of the handpiece. Uchida et al teaches a surgical system (Figures 1-2) wherein a handpiece (14) comprises a toggle switch (a switch which is operated by hand) to control a flow of gas through a lumen of the handpiece (paragraphs [0058][0064]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the handpiece, of the system of Saperstein et al, to comprise a toggle switch, as taught by Uchida et al, as such will start a supply of gas when turned on by hand (paragraphs [0035] [0058][0064]).
In regards to claim 13, Saperstein et al is silent about wherein the handpiece comprises a pressable toggle switch which is configured to control the flow of gas through the open lumen of the gas cannula. Uchida et al teaches a surgical system (Figures 1-2) wherein a handpiece (14) comprises a pressable toggle switch (a switch which is operated by hand) which is configured to control a flow of gas through an open lumen of a gas cannula (20) (paragraphs [0058][0064]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the handpiece, of the system of Saperstein et al, to comprise a pressable toggle switch, as taught by Uchida et al, as such will start a supply of gas when turned on by hand (paragraphs [0035] [0058][0064]).
In regards to claim 14, Saperstein et al is silent about a gas pressure sensor configured to be located at the proximal end of the gas cannula. Uchida et al teaches a surgical system (Figures 1-2) comprising a gas pressure sensor (sensor which measures the pressure of the fluid)(gas may be used as the fluid) configured to be located at a proximal end of a gas cannula (20) (paragraphs [0032][0058]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the system, of Saperstein et al, to comprise a gas pressure sensor, as taught by Uchida et al, as such will measure the pressure of the gas which becomes a predetermined pressure of the gas used in a medical device utilized in medical institutions with a function of performing incision or excision of a lesion area as a scalpel by ejecting the gas to the lesion area (paragraphs [0025][0032][0058]).
In regards to claim 23, Saperstein et al is silent about wherein the pulsed mode is in a sinusoidal or square wave pattern. Uchida et al teaches a surgical system (Figures 1-2) wherein a pulsed mode is in a sinusoidal or square wave pattern (Figures 3-5). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the pulsed mode, of the system of Saperstein et al, to be in a sinusoidal or square wave pattern, as taught by Uchida et al, as such will account for the pressure of the gas and a driving voltage for application of the gas used in a medical device utilized in medical institutions with a function of performing incision or excision of a lesion area as a scalpel by ejecting the gas to the lesion area (paragraphs [0025][0042][0045][0048]).
In regards to claim 24, in the modified system of Saperstein et al and Uchida et al, Saperstein et al is silent about wherein the sinusoidal wave pattern is of a selected range of frequencies and amplitudes. Uchida et al teaches wherein the sinusoidal wave pattern is of a selected range of frequencies and amplitudes (Figures 3, 5). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the sinusoidal wave pattern, of the modified system of Saperstein et al and Uchida et al, to be of a selected range of frequencies and amplitudes, as taught by Uchida et al, as such will account for the pressure of the gas used in a medical device utilized in medical institutions with a function of performing incision or excision of a lesion area as a scalpel by ejecting the gas to the lesion area (paragraphs [0025][0042][0048]).
In regards to claim 25, in the modified system of Saperstein et al and Uchida et al, Saperstein et al is silent about wherein the square wave pattern is of a selected range of frequencies. Uchida et al teaches wherein the square wave pattern is of a selected range of frequencies (Figures 4-5). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the square wave pattern, of the modified system of Saperstein et al and Uchida et al, to be of a selected range of frequencies, as taught by Uchida et al, as such will account for a driving voltage for application of the gas used in a medical device utilized in medical institutions with a function of performing incision or excision of a lesion area as a scalpel by ejecting the gas to the lesion area (paragraphs [0025][0045][0048]).
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Saperstein et al, as applied to claim 11 above, and further in view of Huculak et al (US 6,290,690).
In regards to claim 15, Saperstein et al is silent about wherein the gas source controller comprises a foot pedal. Huculak et al teaches a surgical system (Figures 1-4) wherein a gas source controller comprises a foot pedal (120). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the gas source controller, of the system of Saperstein et al, to comprise a foot pedal, as taught by Huculak et al, as such will allow for supplying proportional pneumatic pressure (column 3, lines 40-43).
In regards to claim 16, in the modified system of Saperstein et al and Huculak et al, Saperstein et al is silent about wherein the gas controller unit controls the gas pressure in a linear fashion by the amount of pressure applied to the foot pedal. Huculak et al teaches wherein a gas controller unit (102) controls a gas pressure in a linear fashion by an amount of pressure applied to the foot pedal (column 6, lines 16-32). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the gas controller unit, of the modified system of Saperstein et al and Huculak et al, to control the gas pressure in a linear fashion by the amount of pressure applied to the foot pedal, as taught by Huculak et al, as such will allow a surgeon to choose a desired pressure level (column 6, lines 16-32) as appropriate for the type of surgery conducted (column 9, lines 25-32).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Saperstein et al, as applied to claim 11 above, and further in view of Huculak et al (US 9,517,162).
In regards to claim 18, Saperstein et al is silent about wherein the gas controller unit further comprises a computer system which comprises a computer monitor and a dial or haptic feedback display which is configured to control the gas pressure. Huculak et al teaches a surgical system (Figure 2) wherein a gas controller unit further comprises a computer system (204) which comprises a computer monitor (206) and a dial or haptic feedback display (touch-sensitive screen) which is configured to control a gas pressure (column 5, lines 6-14)(column 4, lines 17-22). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the gas controller unit, of the system of Saperstein et al, to comprise a computer system which comprises a computer monitor and a dial or haptic feedback display, as taught by Huculak et al, as such will allow a user to establish or change one or more operations of the surgical system by interacting with a computer system (column 5, lines 6-14).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Saperstein et al, as applied to claim 1 above, and further in view of Chen et al (Surgical management of massive submacular hemorrhage).
In regards to claim 26, Saperstein et al teaches a method in the eye of a subject in need thereof, the method comprising:
configuring the distal end of a gas cannula (40) of claim 1 in the eye of a subject (Figures 1-2)
presenting a pressurized gas (50) through the gas cannula (Figures 1-2)
Saperstein et al does not teach wherein the method is a method of disrupting and/or dispersing a sub-retinal hemorrhage in the eye of a subject in need thereof, the method comprising: configuring the distal end of the gas cannula of claim 1 to be proximate to a sub-retinal hemorrhage in the eye of the subject; presenting the pressurized gas to the sub-retinal hemorrhage through the gas cannula, and moving the distal end of said gas cannula in a transretinal manner to disrupt or disperse the sub-retinal hemorrhage. Chen et al teaches a method of disrupting and/or dispersing a sub-retinal hemorrhage in the eye of a subject in need thereof, the method comprising: configuring the distal end of a gas cannula (cannula) to be proximate to a sub-retinal hemorrhage (SRH) in the eye of the subject; presenting the pressurized gas (gas) to the sub-retinal hemorrhage through the gas cannula, and moving the distal end of said gas cannula in a transretinal manner to disrupt or disperse the sub-retinal hemorrhage (pages 40-41: Technique). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the method, of Saperstein et al, to be a method of disrupting and/or dispersing a sub-retinal hemorrhage in the eye of a subject in need thereof, the method comprising: configuring the distal end of the gas cannula to be proximate to a sub-retinal hemorrhage in the eye of the subject; presenting the pressurized gas to the sub-retinal hemorrhage through the gas cannula, and moving the distal end of said gas cannula in a transretinal manner to disrupt or disperse the sub-retinal hemorrhage, as taught by Chen et al, as such will improve the subject’s vision to 20/70 with a majority of subretinal blood displaced inferiorly (page 41: Case Follow-Up).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Saperstein et al and Chen et al, as applied to claim 26 above, and further in view of Huculak et al (US 9,517,162).
In regards to claim 27, in the modified method of Saperstein et al and Chen et al, Saperstein et al is silent about wherein the gas cannula is introduced into the eye through a trocar. Huculak et al teaches a method in the eye of a subject in need thereof, wherein a gas cannula (310) is introduced into the eye through a trocar (320) (column 6, lines 16-24). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the gas cannula, of the modified method of Saperstein et al and Chen et al, to be introduced into the eye through a trocar, as taught by Huculak et al, as such will define a passageway used to provide communication between the interior and the exterior of an eye and may be used to introduce items, such as materials or instruments into the eye, such as the gas cannula (column 6, lines 16-24).
Claims 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Saperstein et al and Charles et al, as applied to claim 28 above, and further in view of Yamamoto et al (US 2007/0202186).
In regards to claim 29, in the modified kit of Saperstein et al and Charles et al, Saperstein et al is silent about wherein the therapeutic agent is selected from an anti-VEGF agent or a steroid. Yamamoto et al teaches a kit wherein a therapeutic agent is selected from an anti-VEGF agent or a steroid (paragraph [0009]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the therapeutic agent, of the modified kit of Saperstein et al and Charles et al, to be selected from an anti-VEGF agent or a steroid, as taught by Yamamoto et al, as such will treat macular degeneration, inflammation, and edema (paragraph [0029]).
In regards to claim 30, in the modified kit of Saperstein et al, Charles et al, and Yamamoto et al, Saperstein et al is silent about wherein the anti-VEGF agent is selected from: Avastin (bevacizumab), Lucentis (ranibizumab), Eylea (aflibercept), Beovu (brolucizumab), and Vabysmo (faricimab). Yamamoto et al teaches wherein the anti-VEGF agent is Avastin (bevacizumab) (paragraph [0060]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the anti-VEGF agent, of the modified kit of Saperstein et al, Charles et al, and Yamamoto et al, to be Avastin (bevacizumab), as taught by Yamamoto et al, as such will treat macular degeneration (paragraph [0029]).
In regards to claim 31, in the modified kit of Saperstein et al, Charles et al, and Yamamoto et al, Saperstein et al is silent about wherein the steroid is selected from: Triesence (triamcinolone acetonide), and Kenalog (triamcinolone acetonide). Yamamoto et al teaches wherein the steroid is Triesence (triamcinolone acetonide) (paragraph [0063]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the steroid, of the modified kit of Saperstein et al, Charles et al, and Yamamoto et al, to be Triesence (triamcinolone acetonide), as taught by Yamamoto et al, as such will treat inflammation and edema (paragraph [0029]).
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783