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 .
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, the “first segment” and “second segment” of the chamber 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.
Claim Objections
Claim 1 is objected to because of the following informalities: Line 9 reading “a flow of liquid” should read --a flow of a liquid--. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: Line 7 reading “the first and second compartments” should now read --the first compartment and the second compartment--. 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 4-5 and 7-12 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. Claim 4 recites the limitation “wherein the selective flow member is arranged in the gas supply tube at a distance from the junction member corresponding to a volume of the gas supply tube fillable with liquid” in Lines 1-3. Claim 5 recites the limitation “wherein gas can flow between the first compartment and the second compartment through the selective flow member while liquid in the second compartment is blocked from entering the first compartment” in Lines 7-10. It is unclear from Claims 4 and 5 whether applicant is referring to the same liquid first recited in Claim 1 Line 9 or some new liquid. Examiner is treating the liquid in Claims 4 and 5 as the same liquid first recited in Claim 1. Claims 7-12 are rejected by virtue of their dependence on Claim 5. Appropriate correction and/or clarification is required.
Claim 9 is 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 9 recites the limitation “wherein the respective opening in the respective surface of the first segment and the respective opening in the respective surface of the second segment are substantially aligned along a main axis of the gas supply tube.” It is unclear from this limitation what opening “respective opening” is in regard to. Applicant should reference the specific opening in the claim with proper antecedent basis where necessary. Appropriate correction and/or clarification is required.
Claim 12 is 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 12 recites the limitation “wherein the fluid connection between the gas supply tube and the respective openings comprises one or more Luer connectors.” It is unclear from this limitation what opening “respective openings” is in regard to. Applicant should reference the specific opening in the claim with proper antecedent basis where necessary. Appropriate correction and/or clarification is required.
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 1-3, 5, 8, 11, and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Madden et al. (USPGPub 2022/0193323).
Re Claim 1, Madden teaches an injector (300) for use in ophthalmic applications (Madden Fig. 1, 3A-3C; ¶ 0023), the injector comprising a gas supply tube (114, 232) and a liquid supply tube (116, 206), the gas supply tube (114, 232) and the liquid supply tube (116, 206) interconnected at a junction member (202) that is in fluid communication with an outflow cannula (108, 211) (Madden ¶ 0041), and a selective flow member (222) formed of a hydrophobic membrane (Madden ¶ 0042-0043), the selective flow member (222) arranged in the gas supply tube (114, 232), near the junction member (202), and adapted to allow bidirectional gas flow therethrough and block a flow of liquid therethrough (Madden ¶ 0042-0043; Claim 2).
Re Claim 2, Madden teaches wherein the hydrophobic membrane comprises polytetrafluoroethylene and has a maximum pore size between 0.2 and 1.0 µm (Madden ¶ 0034).
Re Claim 3, Madden teaches wherein the hydrophobic membrane has a thickness between 0.01 and 1 mm (Madden ¶ 0034).
Re Claim 5, Madden teaches wherein the selective flow member (222) is arranged in the gas supply tube (114, 232) in a chamber (338, 350) (Madden ¶ 0040), the chamber (338, 350) having a first segment (338) and a second segment (350) (as seen in Madden Fig. 3B) with the second segment (350) arranged nearest to the junction member (202), wherein the first segment (338) and the second segment (350) each have a respective surface with a respective opening (Madden Fig. 3C), the selective flow member (222) separating the chamber (338, 350) into a first compartment (340) near the first segment (338) and a second compartment (354) near the second segment (Madden ¶ 0039), wherein gas can flow between the first compartment (340) and the second compartment (354) through the selective flow member (222) while liquid in the second compartment (354) is blocked from entering the first compartment (340) (Madden 0040-0041).
Re Claim 8, Madden teaches wherein the first segment (338) and the second segment (350) are releasably connected to each other (Madden 0040-0041).
Re Claim 11, Madden teaches wherein the chamber (338, 350) has a round shape, such as a disc-shape or a spherical shape (Madden Figs. 3A-3C).
Re Claim 13, Madden teaches all of the limitations of Claim 1. Madden further teaches a system comprising a gas supply, and a liquid supply (Madden Claim 9; ¶ 0023), each of the gas supply and the liquid supply connected to the gas supply tube (114, 232) and the liquid supply tube (116, 206), respectively, of the injector (300) and a control unit (100) adapted to: activate the gas supply to push up gas into the gas supply tube (114, 232), past the selective flow member (222) at a gas pressure X and supply gas to the outflow cannula (108, 211), and switch to a supply of the liquid through the outflow cannula (108, 211) by flowing the liquid up to the selective flow member (222) at a liquid pressure higher than the gas pressure X, and supplying the liquid to the outflow cannula (108, 211) (Madden ¶ 0023-0024, 0044-0049).
Re Claim 14, Madden teaches wherein the control unit (100) is further adapted, at the step of activating the gas supply, to activate the liquid supply and push up the liquid past the liquid supply tube (116, 206) to form a liquid to gas junction in the liquid supply tube (116, 206) (Madden ¶ 0023-0024, 0044-0049).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Madden et al. (USPGPub 2022/0193323) in view of Steppe et al. (USPGPub 2008/0066816).
Re Claim 4, Madden teaches wherein the selective flow member (222) is arranged in the gas supply tube (114, 232) at a distance from the junction member (202) corresponding to a volume of the gas supply tube fillable with liquid (Madden Figs. 3A-3C). However, Madden fails to teach wherein the volume is at most 1.5 mL, preferably at most 0.5 mL, and more preferably at most 0.1 mL. Steppe teaches a selective flow member (320) placed in a gas supply tube (906) near a junction member (306) thus minimizing or eliminating "the gap volume 410 between receptacle 400 and external surface 404, which in turn prevents the formation of air or gas bubbles within the infusion solution flow within portion 304" (Steppe ¶ 0021).
Absent a teaching as to the criticality of the selective flow member is placed in the gas supply tube near the junction member so that at most 1.5 mL is fillable with liquid, preferably at most 0.5 mL is fillable with liquid, more preferably at most 0.1 mL is fillable with liquid, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. See MPEP 2144. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the volume of the gas supply tube of Madden fillable with liquid at a volume at most 1.5 mL, preferably at most 0.5 mL, and more preferably at most 0.1 mL for minimizing a gap volume as disclosed by Madden for preventing the formation of air or gas bubbles within the infusion solution flow within portion 304" (Steppe ¶ 0021).
Claims 7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Madden et al. (USPGPub 2022/0193323).
Re Claim 7, Madden teaches all of the limitations of Claim 5. However, Madden does not teach wherein the first segment and the second segment are integral elements of the chamber. However, the use of a one piece construction as opposed to the structure disclosed in Madden is merely a matter of obvious engineering choice. See In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the first segment and the second segment of Madden be integral elements of the chamber where the use of a one piece construction as opposed to the structure disclosed in Madden is merely a matter of obvious engineering choice. See In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965).
Re Claim 10, Madden teaches all of the limitations of Claim 5. However, Madden does not disclose wherein the chamber has a volume of 1 mL, preferably 0.3 mL, more preferably 0.1 mL. However, it would seem the volume of the chamber would be a product of what the device was being used for. Absent a teaching as to the criticality of the chamber having a volume of 1 mL, preferably 0.3 mL, more preferably 0.1 mL, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. See MPEP 2144.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Madden et al. (USPGPub 2022/0193323) in view of Zuk (USPN 5,798,041).
Re Claim 9, Madden teaches all of the limitations of Claim 5. However, Madden fails to teach wherein the respective opening in the respective surface of the first segment and the respective opening in the respective surface of the second segment are substantially aligned along a main axis of the gas supply tube. Zuk teaches a selective flow member (3, 4, 5, 6) being placed in a supply tube (17, 18) in a chamber (23) (as seen in Zuk Fig. 4; Col. 5 Lines 49-59), the chamber (23) having a first segment (1) and a second segment (2), the second segment (2) nearest to an outlet, each of the first segment (1) and the second segment (2) having an opening (15, 16), the opening (15) in the surface of the first segment (1) and the opening (16) in the surface of the second segment (2) being substantially aligned along a main axis of the supply tube (17, 18) (Zuk Fig. 2), wherein the exact position of a center line of the axis may depend on factors such as the weight of the device, the stiffness of inlet tube, whether or not a right angle tube socket and tube guide are used on outlet section, the weight of outlet tube as well as other factors, the configuration also improving flow dynamics (Zuk Col. 16 Lines 30-47).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the respective opening in the respective surface of the first segment and the respective opening in the respective surface of the second segment of Madden to be substantially aligned along a main axis of the gas supply tube as disclosed by Zuk wherein the exact position of a center line of the axis may depend on factors such as the weight of the device, the stiffness of inlet tube, whether or not a right angle tube socket and tube guide are used on outlet section, the weight of outlet tube as well as other factors, the configuration also improving flow dynamics (Zuk Col. 16 Lines 30-47).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Madden et al. (USPGPub 2022/0193323) in view of Liu et al. (USPGPub 2016/0367745).
Re Claim 12, Madden teaches all of the limitations of Claim 5. Madden fails to teach wherein the fluid connection between the gas supply tube and the respective openings comprises one or more Luer connectors. Liu teaches an opening (109) on a first segment (10) and an opening (1151) on a second segment (11) (as seen in Liu Figs. 1-3), wherein a openings comprise Luer connectors for preventing unintended detachment (Liu ¶ 0024). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the openings of Madden to comprise Luer connectors as disclosed by Liu for preventing unintended detachment (Liu ¶ 0024).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Madden et al. (USPGPub 2022/0193323) in view of Lee-Sepsick et al. (USPGPub 2023/0240716).
Re Claim 15, Madden teaches all of the limitations of Claim 13. Madden fails to teach wherein the control unit is adapted to control both the liquid pressure in the liquid supply tube and the gas pressure in the gas supply tube in a range of 0 to 200 mmHg. Lee-Sepsick teaches a control unit adapted to control the liquid pressure and the gas pressure in each supply tube in a range of 0 to 200 mmHg for preventing damage to the eye during a medical procedure (Lee Sepsick ¶ 0119-0121). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the control unit of Madden adapted to control the liquid pressure and the gas pressure in each supply tube in a range of 0 to 200 mmHg as disclosed by Lee-Sepsick for preventing damage to the eye during a medical procedure (Lee-Sepsick ¶ 0119- 0121).
Response to Arguments
Applicant’s arguments with respect to Claims 1-5 and 7-15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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