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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “selective flow member…configured to allow gases to pass through and to block passage of liquid” in claims 1, 4-15, of which details can be found on page 2, lines 8-15; page 5, line 15; and page 7, line 10-28, as well as in Figures 3 and 5.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 10 is objected to because of the following informalities: claim 10 must end in a period. 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 4-12 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.
Regarding claims 4 and 10, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 5, the limitation “the opening” renders the claim indefinite, as it is unclear which opening is referred to as each of the first segment and the second segment has an opening, which is also supported by the different openings claimed in claim 9.
Claims 6-12 are rejected as dependents of claim 5.
Regarding claim 6, the limitation “the opening” renders the claim indefinite as it is unclear which opening is being referred to.
Regarding claim 12, the limitation “the opening” renders the claim indefinite as it is unclear which opening is being referred to.
Claim Rejections - 35 USC § 102
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-7, 9, 11, and 13-14 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Madden et al. (US 2022/0193323).
Regarding claim 1, Madden discloses an injector for use in ophthalmic applications (see Figs. 1-4B), the injector comprising a gas supply tube 114, 232 and a liquid supply tube 116, both supply tubes being interconnected at a junction member 202 that is in fluid communication with an outflow cannula (see Fig. 3C, par. 48), and a selective flow member 222 arranged in the gas supply tube near the junction member (see Fig. 3C), and configured to allow gases to pass through and to block the passage of liquid (see par. 8, 25).
Regarding claim 2, Madden further discloses the selective flow member consists of a membrane comprising polytetrafluorocthylene (see par. 34) and having a maximum pore size between 0.2 and 1.0 micron (see par. 34).
Regarding claim 3, Madden further discloses the membrane has a thickness between 0.01 and 1 mm (par. 34, range of 150-300 microns is 0.15-0.3 mm, which falls within the claimed range).
Regarding claim 5, Madden further discloses the selective flow member 222 arranged in the gas supply tube 114, 232 in a chamber 338, 350, the chamber having a first segment 338 and a second segment 350, the second segment arranged nearest to the junction member (see Fig. 3C), each of the first segment and the second segment having an opening in a respective surface thereof (see Fig. 3C), the selective flow member separating the chamber in a first compartment 340 near the first segment and a second compartment 354 near the second segment (see Fig. 3C), each of the first compartment 340 and the second compartment 354 in fluid connection with the gas supply tube via the opening (see Fig. 3C), and wherein fluid in the second compartment is blocked from entering the first compartment (see Fig. 3C, par. 8, 25).
Regarding claim 6, Madden discloses the respective surface of each of the first segment and the second segment comprises a connector (see Fig. 3C, each segment has portions allowing for connection between the two segments that are extending radially to the opening) extending radially to the opening to receive the gas supply tube (they are all part of the gas supply tube, and therefore receiving other parts constitute receiving gas supply tube), the gas supply tube in fluid communication with the first compartment and the second compartment of the chamber via the opening (see Fig. 3C).
Regarding claim 7, Madden discloses the first segment and the second segment are integral elements of the chamber (see Fig. 3C).
Regarding claim 9, Madden further discloses the opening in the respective surface of the first segment and the opening in the respective surface of the second segment are substantially aligned along a main axis of the gas supply tube (see Fig. 3C, opening below 340 and opening below 356, which are aligned with tube portion above 340 and the axis of that tube portion above 340).
Regarding claim 11, Madden further discloses the chamber has a round shape, a disc-shape, or a spherical shape (see Figs. 3B-3C).
Regarding claim 13, Madden further discloses a system comprising: a control unit (see par. 23-24, 45), a gas supply (see Fig. 1, gas must be supplied to gas supply line 114), and a liquid supply (see Fig. 1, liquid must be supplied to liquid line 116), each of the gas supply and the liquid supply connected to a gas supply tube and a liquid supply tube, respectively, of the injector according to claim 1 (see rejection of claim 1 above), and wherein the control unit is adapted to: activate the gas supply to push up gas into the gas supply tube, pas the selective flow member at a gas pressure X and supply gas to the outflow cannula (see Fig. 1, par. 23-24), and switch to a supply of liquid through the outflow cannula by flowing liquid up to the selective flow member at a liquid pressure higher than the gas pressure X, and supplying the liquid to the outflow cannula (see par. 23-24; 44-49).
Regarding claim 14, Madden further discloses the control unit is further adapted to: at the step of activating the gas supply, activate the liquid supply and push up liquid past the liquid supply tube so as to form a liquid to gas junction in the liquid supply tube (see par. 23-24; 44-49).
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.
Claim(s) 4 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Madden.
Regarding claim 4, Madden discloses the selective flow member is arranged in the gas supply tube near the junction member such that it is fillable with liquid (see Figs. 3B-3C, fillable in chamber compartment 354) but does not disclose being at most 1.5 mL, preferable at most 0.5 mL fillable, more preferably at most 0.1 mL fillable with liquid.
In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Consequently, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the fillable be at most 1.5 mL with liquid, as a device having the claimed relative dimensions would not perform differently than the prior art device of Madden, similar to in Gardner. Furthermore, applicant has not placed any criticality (i.e. unexpected results) related to such a volume, stating a range of including 1.5 mL, 0.5 mL, and 0.1 mL.
Regarding claim 10, Madden discloses the chamber having a volume (see Fig. 3A) but does not disclose the chamber have a volume of 1 mL, preferably 0.3 mL, more preferably 01 mL.
In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Consequently, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the volume be 1 mL, as a device having the claimed relative dimensions would not perform differently than the prior art device of Madden, similar to in Gardner. Furthermore, applicant has not placed any criticality (i.e. unexpected results) related to such a volume, stating arrange of including 1 mL, 0.3 mL, and 0.1 mL.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Madden in view of Buck et al. (US 2021/0316127).
Regarding claim 8, Madden discloses limitations of claim 5 and while showing the first segment and second segment connected (see Fig. 3C), does not specifically disclose releasably connected.
Buck discloses two or more tubing components releasably connectable via complementary luer locks or other connectors (see par. 80). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the connection be releasable, releasable connectors shown as well-known by Buck and this predictably resulting in a connector connecting the required parts. Additionally, such a connection would allow for parts to be accessed/cleaned as required to ensure working parts of the injector.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Madden in view of Laconte et al. (US 2012/0302943).
Regarding claim 12, Madden discloses the limitations of claim 5 but does not disclose the fluid connection between the gas supply tube and the opening comprises one or more Luer connectors.
Lacote discloses an infusion system for ophthalmic fluid (see Fig. 1, Abstract) wherein luers are used to connect various tubes to other components of the system (see par. 35). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a luer between tube 114 and tube 237, which help to make up the gas supply tube, as Laconte discloses it is common for luers to be used to connect various tubes to other components of an infusion system and this would predictably result in a sealed connection between the parts requiring a connection.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Madden in view of Tarkeshian et al. (US 2014/0276639).
Regarding claim 15, Madden discloses limitations of claim 13 but does not disclose the control unit is adapted to control the liquid pressure and the gas pressure in each supply tube in a range of from 0 to 200 mmHg.
Tarkeshian discloses optimizing the irrigation pressure to prevent over or under pressurizing the anterior chamber (see par. 10), and therefore the liquid pressure and the gas pressure are each result effective variables. Tarkeshian discloses a controller controlling irrigation pressure (see par. 7, 29). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the system to have such control, as it involves only adjusting the dimension of a component disclosed to require adjustment and prevent overpressure or underpressure. Therfore, it would have been obvious to a person having ordinary skill in the art to have the control unit adapted to control the liquid pressure and the gas pressure in each supply tube, as Tarkeshian discloses such control and the importance of such control, and it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the system by having the pressure in a range of from 0 to 200 mmHg as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
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 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 17/852,435 (reference application), hereinafter ‘435. Although the claims at issue are not identical, they are not patentably distinct from each other because the following claims of the current application are disclosed by the following claims of ‘435:
Current application
1
2
3
4
5
6
7
‘435
1
2
3
4
5
6
7
Current application
8
9
10
11
12
13
14
‘435
8
9
10
11
12
13
14
Current application
15
‘435
15
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIANA ZIMBOUSKI whose telephone number is (303)297-4665. The examiner can normally be reached 8:30 - 5:00 PST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, REBECCA E EISENBERG can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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