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 .
Status of Claims
As directed by the amendment filed on 28 May 2024: claim(s) 1-14 have been amended.
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 9-11 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation “less than 0.45 μm”, and the claim also recites “less than or equal to 0.22 μm” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claims 10-11, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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: “a device” in claim 1.
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 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)(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.
Claim(s) 1-4, 6, and 8-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mihashi et al. (US 20070090044 A1).
Regarding Claim 1, Mihashi discloses a dispenser for drip-dispensing a sterile liquid product containing at least one surfactant (see Abstract), including
a reservoir including a wall ("peripheral wall" [0029]) defining an internal volume ("outer bottle 1" [0029]; FIG. 2) and adapted to deform under the effect of a pressure exerted on the reservoir by a user of the dispenser and to spontaneously resume its original shape after said pressure is released ("resiliently squeezable" [0029]);
the reservoir furthermore including a flexible bag ("internal layer bag 16" [0028]; FIG. 2) in the internal volume defined by the wall and adapted to contain the sterile liquid product ("liquid may be kept in the internal layer bag" [0015]);
an air-inlet means between the wall of the reservoir and the flexible bag ("entry opening 17 for leading ambient air to the room between the body portion of the bottle 2 and a body 16a of the internal layer bag 16" [0033]; FIG. 2);
a head attached to a neck of the reservoir ("plug body 12, which is fixed on a mouth portion 11a of the bottle 11" [0027]; FIG. 1) and including a drip end piece ("point nozzle part 15" [0027]; FIG. 1) including a dispensing opening ("discharging pass" [0027]);
the dispenser furthermore including a hydrophilic sterilising microporous membrane ("filtration film 25a include a hydrophilic porous planar film … keep the aseptic condition of the inner layer" [0041]; FIG. 1), disposed so as to have the liquid coming from the flexible bag passing through it with a view to delivery of said liquid through the drip end piece ([0041]; FIG. 1);
wherein the dispenser comprises a device ("protection cap 13" [0027]; FIG. 1) configured to keep the membrane wetted by liquid product coming from the reservoir between two dispensings of liquid product ([0027]; FIG. 1);
said microporous membrane being selectively permeable to liquid such that the microporous membrane enables an aqueous liquid to pass while it opposes the passage of gases when it is wetted ("filter 25 is composed of a hydrophilic filter, it is possible to prevent the ambient air from entering into the inner layer since the ambient air cannot pass through the filter 25" [0045]), and further the microporous membrane opposes the return of air into the flexible bag of the reservoir when the dispenser resumes its original shape after the sterile liquid product is dispensed ("ambient air cannot pass through the filter 25" [0045]), the volume of liquid dispensed being compensated for by the entry of a corresponding volume of air between the wall of the reservoir and the flexible bag via the air-inlet means ([0015] & [0045]).
Regarding Claim 2, Mihashi discloses the flexible bag is formed by delamination of an internal layer of the reservoir ("laminated film-peeling double layered bottle 11" [0027]).
Regarding Claim 3, Mihashi discloses the flexible bag is a retractable flexible bag ("It easily shrinks as the liquid inside decreases" [0036]).
Regarding Claim 4, Mihashi discloses the air-inlet means is formed by a hole in the wall of the reservoir adapted to be closed off by a finger of the user ("entry opening 17 may be blocked by blocking the concave part 18 with a finger" [0033]).
Regarding Claim 6, Mihashi discloses the device configured to keep the membrane wetted between two instillations is a removable cap ("protection cap 13" [0027]; FIG. 1), attached to the dispensing head ([0027]; FIG. 1).
Regarding Claim 8, Mihashi discloses the dispenser further includes a porous pad ("internal liquid holding member 25b" [0042]; FIG. 1) located between the reservoir and the microporous membrane (see FIG. 1) and disposed so as to have the liquid coming from the flexible bag passing through the porous pad with a view to delivery of said liquid through the drip end piece ("internal liquid to pass through the holding member 25b from the discharging upstream side (inside of the bottle) to the discharging downstream side (nozzle side)" [0042]).
Regarding Claim 9, Mihashi discloses the microporous membrane has a pore size of less than 0.45 μm ("0.1 μm and 0.31 μm" [0041]) and preferably less than or equal to 0.22 μm.
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.
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) 5 & 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mihashi in view of Hamamoto (US 20020190079 A1).
Regarding Claims 5 & 7, Mihashi fails to specify the air-inlet means includes a unidirectional valve, configured to allow air to enter between the wall of the reservoir and the flexible bag and to prevent the air present between the wall of the reservoir and the flexible bag from emerging towards the outside of the reservoir; wherein the device configured to keep the membrane wetted between two instillations includes a valve positioned between the membrane and the dispensing opening of the drip end piece. However, Hamamoto teaches a dispensing container comprises a delaminating bottle (Abstract) comprising “at least one vent(s) 4” ([0044]) wherein the air-inlet means includes a unidirectional valve ("check valve may be disposed in each of vents" [0011]), configured to allow air to enter between the wall of the reservoir and the flexible bag ("vents will allow an amount of ambient air to enter a cavity between the bag and bottle" [0011]) and to prevent the air present between the wall of the reservoir and the flexible bag from emerging towards the outside of the reservoir ("check valve inhibits outflow of the ambient air having entered the clearance" [0030]); wherein the device configured to keep the membrane wetted between two instillations includes a valve (comprising of "flexible nozzle 31" and "closer 32" [0059]) positioned between the membrane and the dispensing opening of the drip end piece. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Mihashi to incorporate the teachings of Hamamoto to suitably control “inflow of ambient air into a clearance between the exterior bottle and interior bag” ([0030]) and rate of dispense ([0035]).
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mihashi in view of Pardes et al. (US 20090236374 A1).
Regarding Claims 10-11, Mihashi fails to specify the surfaces of the dispenser located between the microporous membrane and the dispensing opening carry a bactericidal coating, for example based on silver ions or zinc ions; the microporous membrane includes a bactericidal agent, for example based on silver ions or zinc ions. However, Pardes teaches “a dispensing or delivery system conveys a flowable substance from a closed source, such as a collapsible reservoir within a rigid container or a rigid reservoir” ([0006]) wherein the surfaces of the dispenser located between the microporous membrane and the dispensing opening carry a bactericidal coating ("may be formed from hydrophobic or antimicrobial material or be coated with a hydrophobic or anti-microbial coating" [0087]); wherein the microporous membrane includes a bactericidal agent ("elastomers, and the materials comprising any of the other components of the device may have integrated, impregnated, otherwise placed within them anti-microbial ingredients such as silver ions" [0086]). Therefore, it would have been obvious to modify the device of Mihashi to suitably maintain “the purity or sterility of the product remaining in the reservoir” ([0091]).
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mihashi in view of Stringer et al. (US 20210315924 A1).
Regarding Claims 12-14, Mihashi fails to specify said dispenser including in its reservoir a preservative-free sterile liquid ophthalmic product containing at least one surfactant; wherein the sterile liquid ophthalmic product includes between 0.1% and 5% surfactant by volume; wherein the at least one surfactant includes one or more of the following agents: Polyethylene glycol 400 (PEG 400); Polyoxyethylene sorbitan monooleate (polysorbate 80); Polyoxyethylene sorbitan monolaurate (polysorbate 20); Ethylene oxide, propylene oxide; Methyloxirane polymer; Castor oil PEG-35; Hydrogenated castor oil PEG-40; Macrogol cetostearyl ether; Polyoxypropyl glycol 407; Vitamin E (polyethylene glycol succinate); Macrogol hydroxystearate 15; Caprylocaproyl macrogol-8 glycerides; 2-(2-ethoxyethoxy) ethanol; Polyvinylpyrrolidone. However, Stringer teaches “formulations and compositions for ocular diseases” (Abstract) comprising a preservative-free ("preservative free" [0003]) sterile liquid ophthalmic product containing at least one surfactant ([0003]); wherein the sterile liquid ophthalmic product includes between 0.1% and 5% surfactant by volume ("polysorbate 80 is provided at about 0.01% to about 1% by weight (% wt/wt) or weight by volume (% wt/v)" [0036]); wherein the at least one surfactant includes one or more of the following agents: Polyethylene glycol 400 (PEG 400); Polyoxyethylene sorbitan monooleate (polysorbate 80); Polyoxyethylene sorbitan monolaurate (polysorbate 20); Ethylene oxide, propylene oxide; Methyloxirane polymer; Castor oil PEG-35; Hydrogenated castor oil PEG-40; Macrogol cetostearyl ether; Polyoxypropyl glycol 407; Vitamin E (polyethylene glycol succinate); Macrogol hydroxystearate 15; Caprylocaproyl macrogol-8 glycerides; 2-(2-ethoxyethoxy) ethanol; Polyvinylpyrrolidone ("polysorbate 80" [0036]). Therefore, it would have been obvious to modify the device of Mihashi to suitably provide a preservative free ophthalmic composition ([0007]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO-892 form are considered relevant to applicant’s disclosure and are cited to further show the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781
Prosecution Insights