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 .
Claim Objections
Claims 1, 5 and 23 are objected to because of the following informalities:
Claim 1, line 5 recites “distal end” and should recite “a distal end”.
Claim 5, lines 2-3 recite “a spatulated, fan-shaped, round, prolate round, or rectangular shape” and should recite “a spatulated shape, a fan-shaped shape, a round shape, a prolate round shape, or a rectangular shape”.
Claim 23, lines 1-2 recites “the eye” and should recite “an eye”.
Claim 23 recites “a. configuring the distal end of a gas pressure modulator handpiece of any of claims 12-18 to be proximate to a sub-retinal hemorrhage in the eye of a subject” and should recite “a. configuring the distal end of the gas pressure modulator handpiece of any of claims 12-18 to be proximate to the sub-retinal hemorrhage in the eye of 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 1-28 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.
Claim 1, line 12 recites “dispensed air”. Claim 1, line 7 recites “pressurized air or medical grade gas”. It is unclear whether the two terms refer to the same component or to different components. Additionally it is unclear if this limitation further limits the “pressurized air or medical grade gas” to only air. Clarification is required. For purposes of examination this is assumed to refer to the pressurized air or medical grade gas recited earlier in the claim.
Claim 4 recites “the propagated and ejected gas”. It is unclear if this refers to the pressurized air or medical grade gas recited in base claim 1 or a different element. Clarification is required. For purposes of examination this is assumed to refer to the pressurized air or medical grade gas recited in claim 1.
Claim 5 recites “the one or more distal openings”. This limitation lacks antecedent basis in the claims. It is further unclear if it refers to the pressurized air or medical grade gas recited in base claim 1 or a different element. Clarification is required. For purposes of examination this is assumed to refer to the pressurized air or medical grade gas recited in claim 1.
Claim 5 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. Clarification is required. For purposes of examination this is assumed to refer to the same elements.
Claim 7, lines 1-2 and 3 each recite “an inline gas filter”. It is unclear if these two recitations refer to the same element or two elements. Clarification is required. For purposes of examination these two recitations are assumed to refer to the same element.
Claim 8 recites “an inline gas filter”. It is unclear if this refers to the inline gas filter recitations in claim 7 or an additional element. Clarification is required. For purposes of examination this limitation is assumed o refer to the recitations in claim 7.
Claim 9, lines 1-2 and 3 each recite “a gas regulator”. It is unclear if these two recitations refer to the same element or two elements. Clarification is required. For purposes of examination these two recitations are assumed to refer to the same element.
Claim 10, lines 1-2 and 3 each recite “a pressurized gas source”. It is unclear if these two recitations refer to the same element or two elements. Clarification is required. For purposes of examination these two recitations are assumed to refer to the same element.
Claim 11, lines 1-2 recites “a gas cylinder” and line 3 recites “a pressurized gas cylinder”. It is unclear if these two recitations refer to the same element or two elements. Clarification is required. For purposes of examination these two recitations are assumed to refer to the same element.
Claim 12 recites “an open lumen”. It is unclear if this refers to the same named element recited in base claim 1 or an additional open lumen. Clarification is required. For purposes of examination this limitation is assumed to refer to the open lumen recited in base claim 1.
Claim 12 recites “one or a plurality of first gas egress ports”. It is unclear if these ports refer to the one or more openings recited in base claim 1 or an additional element. Clarification is required. For purposes of examination these are assumed to refer to the same elements.
Claim 14 recites “one or a plurality of second gas egress ports”. It is unclear if these ports refer to the one or more openings recited in base claim 1 or an additional element. Clarification is required. For purposes of examination these are assumed to refer to the same elements.
Claim 19 recites “the pressurized gas”. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this refers to the pressurized air or medical grade gas recited in base claim 1 or an additional element. Clarification is required. For purposes of examination this is assumed to refer to the elements described in base claim 1.
Claim 19 recites “the modulated exit gas tube”. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is meant to refer to the wall surrounding the open lumen recited in base claim 1 or an additional element. Clarification is required. For purposes of examination this is assumed to refer to the wall surrounding the open lumen recited in base claim 1.
Claim 23, line 6 recites “a pressurized gas”. It is unclear if this refers to the pressurized air or medical grade gas recited in base claim 1 or an additional element. Clarification is required. For purposes of examination this is assumed to refer to the elements described in base claim 1.
Claim 24 recites “the gas cannula”. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is meant to refer to the wall surrounding the open lumen recited in base claim 1 or an additional element. Clarification is required. For purposes of examination this is assumed to refer to the wall surrounding the open lumen recited in base claim 1.
Claims dependent thereon inherit the deficiencies of the respective base claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 22 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 22 recites “wherein the pressurized gas is selected from medical-grade gas or air” and base claim 1 recites “pressurized air or medical grade gas”. Therefore claim 22 does not appear to further limit claim 19. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-2, 4-12, 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Saperstein et al. (US Patent 5,919,158) in view of Niederjohn et al. (US Patent 6,168,577).
Regarding claim 1, Saperstein discloses a gas pressure modulator handpiece (Figure 4, 40) comprising:
a. a wall (42) surrounding an open lumen (space within 42);
b. a longitudinal axis (line 4--4) along the open lumen (Figure 3);
c. a proximal end (42a); and
d. 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 through distal end (Figures 1 and 4),
and 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 and 4).
Saperstein is silent on wherein the proximal end is in fluidic communication with a filtered gas feed tube.
Niederjohn teaches wherein the proximal end (Figure 1A, 170) is in fluidic communication with a filtered gas feed tube (Figure 1A, gas tube 150 with filter 140).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Saperstein’s invention to include wherein the proximal end is in fluidic communication with a filtered gas feed tube in order provide a clean fluid to the surgical field as suggested and taught by Niederjohn in col. 5, ll. 50-59.
Regarding claim 2, Saperstein in view of Niederjohn teach the invention as claimed and described above. Saperstein further teaches wherein the laminar flow pattern is an air knife (col. 5, ll. 15-23).
Regarding claim 4, Saperstein in view of Niederjohn teach the invention as claimed and described above. Saperstein further teaches wherein the propagated and ejected gas is propagated in a continuous or pulsed manner (col. 5, ll. 1-24 describes a continuous manner).
Regarding claim 5, Saperstein in view of Niederjohn teach the invention as claimed and described above. Saperstein further 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 (Figure 3 shows a round profile).
Regarding claim 6, Saperstein in view of Niederjohn teach the invention as claimed and described above. Saperstein further teaches wherein the one or more distal openings comprise a prolate round shape (Figure 4).
Regarding claim 7, Saperstein in view of Niederjohn teach the invention as claimed and described above. Niederjohn further teaches further comprising an inline gas filter (140), wherein the filtered gas feed tube is in fluidic communication with an inline gas filter (Figure 1A).
Regarding claim 8, Saperstein in view of Niederjohn teach the invention as claimed and described above. Niederjohn further teaches further comprising an inline gas filter (140), wherein the inline gas filter is in fluidic communication with a pre-filtered gas feed tube (Figure 1A, 145).
Regarding claim 9, Saperstein in view of Niederjohn teach the invention as claimed and described above. Niederjohn further teaches further comprising a gas regulator (col. 5, ll. 50-53 describes the gas supply as a regulated source of pressurized gas, i.e. having a gas regulator), wherein the pre-filtered gas feed tube is in fluidic communication with a gas regulator (col. 5, ll. 50-59).
Regarding claim 10, Saperstein in view of Niederjohn teach the invention as claimed and described above. Niederjohn further teaches further comprising a pressurized gas source (col. 5, ll. 50-53 describes the gas supply as a regulated source of pressurized gas, i.e. a pressurized gas source) wherein the gas regulator is in fluidic communication with a pressurized gas source (col. 5, ll. 50-59).
Regarding claim 11, Saperstein in view of Niederjohn teach the invention as claimed and described above. Saperstein further teaches further comprising a gas cylinder wherein the pressurized gas source is a pressurized gas cylinder (Saperstein, col. 3, ll. 57-58).
Regarding claim 12, Saperstein in view of Niederjohn teach the invention as claimed and described above. Saperstein further teaches wherein the wall surrounding an open lumen (space within 42) comprises one or a plurality of first gas egress ports (Figure 4 shows at least two openings 46).
Regarding claim 19, Saperstein in view of Niederjohn teach the inventions of claims 1-8 as claimed and described above. The combination of Saperstein in view of Niederjohn further teach a surgical system (Niederjohn Figure 1A), comprising:
a. the gas pressure modulator handpiece of any of claims 1-8 (see rejections above);
b. a gas regulator (Niederjohn, col. 5, ll. 50-53 describes the gas supply as a regulated source of pressurized gas, i.e. having a gas regulator); and
c. a pressurized gas cylinder (Saperstein, col. 3, ll. 57-58),
wherein the handpiece is configured to selectively control the flow rate of the pressurized gas into the modulated exit gas tube (Niederjohn col. 10, ll. 23-26 and ll. 50-60 describe the handpiece 165 controls the flow rate of the pressurized gas to the modulated exit gas tube).
Regarding claim 20, Saperstein in view of Niederjohn teach the invention as claimed and described above. Saperstein further teaches wherein the flow rate of the pressurized gas ranges from 0.1 to 20 standard liters per minute (SLPM) (Intended use, the invention is structurally capable of providing the pressurized gas at .1 to 20 standard liters per minute).
Regarding claim 21, Saperstein in view of Niederjohn teach the invention as claimed and described above. Saperstein further teaches wherein the pressure of the pressurized gas ranges from 0.1 to 30 psi (col. 7, ll. 12-14 describes the pressure as 35mmHg, i.e. about .68psi).
Regarding claim 22, Saperstein in view of Niederjohn teach the invention as claimed and described above. Saperstein further teaches wherein the pressurized gas is selected from medical-grade gas or air (col. 3, ll. 50-62 describes air).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Saperstein et al. (US Patent 5,919,158) in view of Niederjohn et al. (US Patent 6,168,577) and further in view of Charles et al (US Patent 11,033,427).
Regarding claim 3, Saperstein in view of Niederjohn teach all the essential features of the invention as claimed and described above except wherein the open lumen has a longitudinal diameter ranging from 14-31 gauge.
Charles teaches a gas cannula (Figures 1-3A, cannula 12) wherein an open lumen (33) has a longitudinal diameter ranging from 14-31 gauge (col. 6, ll. 49-50 describes a longitudinal diameter of about 20 to about 27 gauge).
Therefore 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 Saperstein in view of Niederjohn’s invention to include wherein the open lumen has a longitudinal diameter ranging from 14-31 gauge in order to allow for vitreoretinal surgery in which the cannula may be inserted into the eye behind the retina, such as for draining subretinal fluid as suggested and taught by Charles in col. 4, ll. 58-60.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Saperstein et al. (US Patent 5,919,158) in view of Niederjohn et al. (US Patent 6,168,577) and further in view of Chen et al (Surgical management of massive submacular hemorrhage).
Regarding claim 23, Saperstein in view of Niederjohn teach the invention as claimed and described above. Saperstein further teaches
a. configuring the distal end (41) of a gas pressure modulator handpiece (40) of any of claims 12-18 (see rejection of claim 12 above);
b. presenting a pressurized gas (50) through the gas pressure modulator handpiece (Figure 1).
Saperstein in view of Niederjohn are silent on a method of disrupting and/or dispersing a sub-retinal hemorrhage in the eye of a subject in need thereof, the method comprising:
a. configuring the distal end of the gas pressure modulator handpiece of any of claims 12-18 to be proximate to a sub-retinal hemorrhage in the eye of a subject;
b. presenting the pressurized gas to the sub-retinal hemorrhage through the gas pressure modulator handpiece; and
c. moving the distal end of said gas pressure modulator handpiece in a transretinal manner to disrupt or disperse the sub-retinal hemorrhage.
Chen teaches a method of disrupting and/or dispersing a sub-retinal hemorrhage in the eye of a subject in need thereof (pages 40-41, Technique), the method comprising:
a. configuring the distal end of the gas pressure modulator handpiece of any of claims 12-18 to be proximate to a sub-retinal hemorrhage in the eye of a subject (page 40-41 describes inserting a subretinal cannula into eye);
b. presenting the pressurized gas to the sub-retinal hemorrhage through the gas pressure modulator handpiece (page 41 describes injecting the pressurized gas); and
c. moving the distal end of said gas pressure modulator handpiece in a transretinal manner to disrupt or disperse the sub-retinal hemorrhage (page 41 describes moving the cannula in a transretinal manner to disrupt the subretinal clot).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Saperstein in view of Niederjohn’s invention to include a method of disrupting and/or dispersing a sub-retinal hemorrhage in the eye of a subject in need thereof, the method comprising:
a. configuring the distal end of the gas pressure modulator handpiece of any of claims 12-18 to be proximate to a sub-retinal hemorrhage in the eye of a subject;
b. presenting the pressurized gas to the sub-retinal hemorrhage through the gas pressure modulator handpiece; and
c. moving the distal end of said gas pressure modulator handpiece in a transretinal manner to disrupt or disperse the sub-retinal hemorrhage in order to improve the subjects vision as suggested and taught by Chen on page 41.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Saperstein et al. (US Patent 5,919,158) in view of Niederjohn et al. (US Patent 6,168,577) and Chen et al (Surgical management of massive submacular hemorrhage, and further in view of Huculak et al (US Patent 9,517,162).
Regarding claim 24, Saperstein in view of Niederjohn and Chen teach all the essential features of the invention as claimed and described above except wherein the gas cannula is introduced into the eye through a trocar.
Huculak teaches wherein the gas cannula (310) is introduced into the eye through a trocar (320) (column 6, lines 16-24).
Therefore 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 Saperstein in view of Niederjohn and Chen’s invention to include wherein the gas cannula is introduced into the eye through a trocar in order to 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 (col. 6, ll. 16-24).
Claims 25-28 are rejected under 35 U.S.C. 103 as being unpatentable over Saperstein et al. (US Patent 5,919,158) in view of Niederjohn et al. (US Patent 6,168,577) and further in view of Yamamoto et al. (US 2007/0202186).
Regarding claim 25, Saperstein in view of Niederjohn teach the invention as claimed and described above. Saperstein further teaches a kit (Figure 1) comprising:
a. the gas pressure modulator handpiece of any of claims 1-18 (see rejection above).
Saperstein in view of Niederjohn are silent on b. a therapeutic agent.
Yamamoto teaches b. a therapeutic agent (paragraph 9).
Therefore 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 Saperstein in view of Niederjohn’s invention to include b. a therapeutic agent in order to treat macular degeneration, inflammation, and edema as suggested and taught in paragraph 29.
Regarding claim 26, Saperstein in view of Niederjohn and Yamamoto teach the invention as claimed and described above. Yamamoto further teaches wherein the therapeutic agent is selected from an anti- VEGF agent or a steroid (paragraph 9).
Regarding claim 27, Saperstein in view of Niederjohn and Yamamoto teach the invention as claimed and described above. Yamamoto further teaches wherein the anti-VEGF agent is selected from: Avastin (bevacizumab), Lucentis (ranibizumab), Eylea (aflibercept), Beovu (brolucizumab), and Vabysmo (faricimab) (paragraph 60 describes bevacizumab).
Regarding claim 28, Saperstein in view of Niederjohn and Yamamoto teach the invention as claimed and described above. Yamamoto further teaches wherein the steroid is selected from: Triesence (triamcinolone acetonide), and Kenalog (triamcinolone acetonide) (paragraph 63 describes triamcinolone acetonide).
Allowable Subject Matter
Claims 13-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In addition to the art described above, Aljuri et al. (US 2016/0143778), Kraff et al. (US Patent 5,667,489), Pingleton et al. (US Patent 6,117,150), Ianchulev et al. (US 2016/0074220), Schaller et al. (US 2019/0183681) and Lambert (US 2022/0265469) each teach elements of the invention.
The prior art of record fails to anticipate and/or render obvious, either alone or in combination, the egress ports and sliding mechanisms described in claim 13.
Claims dependent thereon include the allowable subject matter of the respective base claim.
Conclusion
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/KATHERYN A MALATEK/ Primary Examiner, Art Unit 3741
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