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
Claims 1, 34, and 35 are directed towards delivery of a preservative free composition but do not require the inclusion of a preservative. The term “ophthalmic solution” is used to describe the claimed solution both before and after distribution. The claims are interpreted to not require a preservative in the ophthalmic solution, but the claim rejections are presented to address an ophthalmic solution which contains a preservative which is then removed while the solution is dispensed, in order to address alternate interpretations.
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 1-17 and 34-36 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.
Claims 1, 34, and 35 recites the limitation “the ophthalmic composition is substantially preservative free” which is indefinite. It is unclear from the claims or specification what tolerances are allowable based on “substantially preservative free”. Claim 11, which depends on claim 1, indicates the dispensed composition may contain less than about 1% - 0.0001% preservative. It is therefore unclear if “substantially preservative free” would thereby indicate a presence of greater than 1% in order for claim 11 to further narrow the device of claim 1.
Claim 4 recites the limitation “the ophthalmic composition has a pD of one of. less than about 7.3, less than about 7.2, less than about 7.1…after an extended period of time under storage condition” which is indefinite. It is unclear from the claims or specification what tolerances are allowable based on “less than about”. Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991).
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 4 recites the broad recitation “less than about 7.3”, and the claim also recites “less than about 4.8” 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.
Claim 4 recites the limitation “an extended period of time” which is indefinite. Storage of ophthalmic solutions can range from weeks to years depending on a variety of factors. It is unclear how long the composition must be stable based on the claim language.
Claims 5 and 11 recite the limitation “the ophthalmic composition comprises one of: less than about 1%, less than about 0.5%, less than about 0.4%, less than about 0.3%, less than about 0.2%...of a preservative” which is indefinite. It is unclear from the claims or specification what tolerances are allowable based on “less than about”. Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991).
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, claims 5 and 11 recite the broad recitation “less than about 0.5%”, and the claims also recite “less than about “0.001%” 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.
Claim 16 details the materials used in construction of the reservoir. Said materials are listed in groups separated by a semi-colon when it appears that this is a list wherein a single material is required (not one from each semi-colon separated group). As the instant specification [0013] lists these groups as separate embodiments, this list is treated as a single Markush group.
Claim 35 recites the limitation "step b)" in line 9. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, this is considered to be step d).
Claims 2, 3, 6-10, 12-15, 17, and 36 are rejected based on their dependency.
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.
Claim(s) 1-13, 15, and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016172712 A2 (Baker et al.) in view of US 20170224531 A1 (Chauhan et al.).
Regarding Claim 1, Baker teaches an ophthalmic product (Abstract), comprising:
a) a fluid-dispensing device, usable in some embodiments [00240], comprising a reservoir [00242] and use of a dispensing tip [00328] fitted onto the reservoir, the tip necessarily connected to the reservoir in order to deliver the contents;
b) an ophthalmic composition comprising from about 0.001 wt.% to about 0.05 wt.% of a muscarinic antagonist and deuterated water, at a pD of from about 4.2 to about 7.9, in the reservoir [0003];
wherein the ophthalmic composition is dispensed from the dispensing tip into an eye of an individual in need thereof [00328].
Baker teaches the inclusion of preservatives is optional [0049] but fails to teach the dispensed ophthalmic composition is substantially preservative-free by means of preservative removal.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of Baker with the dispensing device further taught by Baker to allow for controlled release of the ophthalmic composition [00242], thereby allowing the treatment to be delivered to the patient [00240].
Chauhan discloses a preservative removal filter plug [0010] for use in a dispensing bottle containing a reservoir and tip (Chauhan Annotated Fig. 1B) capable of removing 100% of the preservative [0068] and therefore preservative free, said system being a TearClear filter system as cited in the instant specification [0347].
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Chauhan Annotated Fig. 1B
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Baker to incorporate the preservative removal system of Chauhan to reduce the negative impacts of preservatives on the patient [Chauhan 0004].
Regarding Claims 2 and 3, Baker in view of Chauhan teaches the ophthalmic product of claim 1.
Baker further discloses the muscarinic antagonist comprises atropine, atropine sulfate, noratropine, atropine-N-oxide, tropine, tropic acid, hyoscine, scopolamine, tropicamide, cyclopentolate, pirenzapine, homatropine, or a combination thereof [0005].
Regarding Claim 4, Baker in view of Chauhan teaches the ophthalmic product of claim 1.
Baker further teaches the ophthalmic composition has a pD of one of: less than about 7.3, less than about 7.2, less than about 7.1, less than about 7, less than about 6.8, less than about 6.5, less than about 6.4, less than about 6.3, less than about 6.2, less than about 6.1, less than about 6, less than about 5.9, less than about 5.8, less than about 5.2, or less than about 4.8 after an extended period of time under storage condition [0007].
Regarding Claim 5, Baker in view of Chauhan teaches the ophthalmic product of claim 1.
Baker further teaches the ophthalmic composition comprises one of: less than about 1%, less than about 0.5%, less than about 0.4%, less than about 0.3%, less than about 0.2%, less than about 0.1%, less than about 0.01%, or less than about 0.001% of a preservative [00146].
Regarding Claim 6, Baker in view of Chauhan teaches the ophthalmic product of claim 1.
Baker further teaches that in some embodiments the ophthalmic composition further comprises a preservative [0049]. As the preservative is taught to be optionally included, Baker is considered to teach the ophthalmic composition is preservative-free.
Regarding Claim 7, Baker in view of Chauhan teaches the ophthalmic product of claim 1.
Baker fails to teach the fluid-dispensing device comprises an internal filter or membrane.
Chauhan teaches the preservative removal device comprises a filter [0045] as described in claim 1.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the preservative removal plug of Baker in view of Chauhan to include a filter to allow for a variety of formulations with varied viscosities to be used in the device [Chauhan 0043].
Regarding Claim 8, Baker in view of Chauhan teaches the ophthalmic product of claim 7.
Baker fails to teach the internal filter or membrane is located within the fluid-dispensing device at a position capable of removing a preservative from the ophthalmic composition prior to dispensing the ophthalmic composition into the eye of the individual.
In the device of Baker in view of Chauhan of claim 1, Chauhan teaches the internal filter or membrane is located within the fluid-dispensing device at a position capable of removing a preservative from the ophthalmic composition prior to dispensing the ophthalmic composition into the eye of the individual (Fig. 1B), as the filter is located between the reservoir and dispensing tip [0014] as indicated in claim 1.
Regarding Claim 9, Baker in view of Chauhan teaches the ophthalmic product of claim 7.
Baker fails to teach the internal filter or membrane is located within the fluid-dispensing device at a position capable of removing a microorganism and/or an endotoxin from the ophthalmic composition prior to dispensing the ophthalmic composition into the eye of the individual.
Chauhan further teaches an ophthalmic product (Fig. 1A and 1B) comprising an internal filter [0016] which is located within the fluid-dispensing device at a position capable of removing a microorganism from the ophthalmic composition prior to dispensing the ophthalmic composition into the eye of the individual [0099].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the internal filter of Baker in view of Chauhan with the microorganism removal of Chauhan to ensure safety of the user [Chauhan 0003].
Regarding Claim 10, Baker in view of Chauhan teaches the ophthalmic product of claim 7.
Baker fails to teach an internal filter system.
Chauhan further teaches the preservative removing device, acting as an internal filter, comprises silicone [0010].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the biocompatible filter of Baker in view of Chauhan with the material selection of Chauhan as a simple substitution of one biocompatible material for another with a reasonable expectation of filtering preservatives as taught by Chauhan [0010] MPEP 2143 I.
Regarding Claims 11 and 12, Baker in view of Chauhan teaches the ophthalmic product of claim 1.
Baker fails to teach the dispensed ophthalmic composition comprises one of: less than about 1%, less than about 0.5%, less than about 0.4%, less than about 0.3%, less than about 0.2%, less than about 0.1%, less than about 0.01%, less than about 0.001%, or less than about 0.0001% of a preservative.
Chauhan further teaches the dispensed ophthalmic composition comprises one of: less than about 1%, less than about 0.5%, less than about 0.4%, less than about 0.3%, less than about 0.2%, less than about 0.1%, less than about 0.01%, less than about 0.001%, or less than about 0.0001% of a preservative by teaching 100% removal of the preservative (Fig. 7) [0069], this being considered preservative free.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Baker in view of Chauhan to remove a high percentage of the preservative as taught by Chauhan in order to minimize the negative impacts of preservatives on the patient [Chauhan 0004].
Regarding Claim 13, Baker in view of Chauhan teaches the ophthalmic product of claim 1.
Baker fails to teach the reservoir is at least partially elastically deformable so as to dispense the ophthalmic composition by pressing on the reservoir.
Chauhan teaches the bottle which forms the reservoir is compressible [0014] and teaches conditions wherein the fluid is sucked back into the bottle [0043, 0054] and is therefore considered to teach the reservoir is at least partially elastically deformable so as to dispense the ophthalmic composition by pressing on the reservoir.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bottle of Baker in view of Chauhan to be elastically deformable as it would be obvious to try when looking to common store-bought delivery systems with a reasonable expectation of providing a container which allows multiple doses of a solution MPEP 2143 I.
Regarding Claim 15, Baker in view of Chauhan teaches the ophthalmic product of claim 1.
Baker fails to teach the reservoir comprises a polymeric material.
Chauhan teaches typical eye drop dispensing systems utilize an elastic, plastic bottle. As the reservoir is contained with the plastic bottle, Chauhan is considered to teach the reservoir comprises a polymeric material.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bottle of Baker in view of Chauhan to comprise a polymeric material as use of a typical drop dispensing system [Chauhan 0054] would be readily familiar to users and therefore obvious to try when considering existing drop deployment devices.
Chauhan further teaches 100% removal of the preservative [0069] (Fig. 7) and is therefore considered to teach the fluid-dispensing device enables dispensing a preservative-free ophthalmic composition.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Baker to incorporate the preservative removal system of Chauhan to reduce the negative impacts of preservatives on the patient [Chauhan 0004].
Regarding Claim 34, Baker teaches an ophthalmic product, comprising:
an ophthalmic composition comprising from about 0.001 wt.% to about 0.05 wt.% of a muscarinic antagonist and deuterated water, at a pD of from about 4.2 to about 7.9 [0003];
Baker teaches a fluid-dispensing device, usable in some embodiments [00240], comprising a reservoir [00242] and use of a dispensing tip [00328] which is dispensed into the eye [00328], but fails to teach a multi-dose preservative free fluid-dispensing device comprising a reservoir and a dispensing tip fitted onto the reservoir and wherein the ophthalmic composition is dispensed from the dispensing tip into an eye of an individual in need thereof, and wherein the ophthalmic composition is substantially preservative- free.
Chauhan discloses a multi-dose preservative free fluid-dispensing device (Fig. 1B) (Abstract) comprising a reservoir and a dispensing tip fitted onto the reservoir (Chauhan Annotated Fig. 1B); and
wherein the ophthalmic composition is dispensed from the dispensing tip into an eye of an individual in need thereof [0044], and capable of removing 100% of the preservative [0068] and therefore substantially preservative free.
Chauhan discloses a preservative removal filter plug [0010] for use in a dispensing bottle containing a reservoir and tip (Chauhan Annotated Fig. 1B) which is capable of removing 100% of the preservative [0068] and therefore preservative free, said system being a TearClear filter system as cited in the instant specification [0347].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of Baker to be dispensed from the reservoir and tip of the preservative removing device of Chauhan to reduce the negative impacts of preservatives on the patient [Chauhan 0004].
Regarding Claim 35, Baker teaches a method of delivering an ophthalmic composition to an eye of an individual in need thereof, comprising:
c) generating at least one droplet [00195] containing an ophthalmic composition comprising from about 0.001 wt.% to about 0.05 wt.% of a muscarinic antagonist and deuterated water, at a pD of from about 4.2 to about 7.9 [0036], via a fluid-dispensing device comprising a reservoir [00242] and a dispensing tip fitted onto the reservoir [00328]; and
d) delivering the at least one droplet containing said ophthalmic composition to the eye of the individual [0036], an effective amount being considered at least one drop;
Baker teaches the inclusion of preservatives is optional [0049] but fails to teach the ophthalmic composition dispensed in step d) is substantially preservative-free by means of preservative removal.
Chauhan discloses a preservative removal plug [0010] for use in a dispensing bottle containing a reservoir and tip (Chauhan Annotated Fig. 1B) capable of removing 100% of the preservative [0068] and therefore preservative free, said system being a TearClear filter system as cited in the instant specification [0347].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Baker to incorporate the preservative removal system of Chauhan to reduce the negative impacts of preservatives on the patient [Chauhan 0004].
Regarding Claim 36, Baker in view of Chauhan teaches the method of claim 35.
Baker further teaches the individual has pre-myopia or myopia [0034].
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Baker in view of Chauhan and further in view of US 20140336618 A (Wilkerson et al.).
Regarding Claim 14, Baker in view of Chauhan teaches the ophthalmic product of claim 1.
Baker fails to teach the fluid-dispensing device comprises an atomizer, a pump, or a mister.
Wilkerson teaches a fluid-dispensing device (Fig. 1), said device considered an atomizer or mister as it delivers a stream of small droplets (Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dispensing mechanism of Baker in view of Chauhan with the mister of Wilkerson to provide greater control over medication deliver [Wilkerson 0067].
Claim(s) 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Baker in view of Chauhan and further in view of US 20020190079 A1 (Hamamoto).
Regarding Claim 16, Baker in view of Chauhan teaches the ophthalmic product of claim 15.
Baker fails to teach the reservoir material.
While Chauhan teaches an elastic plastic bottle [0054] which would fall under being either a polyvinyl chloride (PVC) plastic or non-PVC plastic (since the two alternatives cover the entire genus of plastics), Chauhan fails to specifically teach the material used.
Hamamoto teaches an eye drop dispensing container (Abstract) (Fig. 1b) wherein the reservoir (exterior bottle 21) is formed of PET [0033], or in the alternate, the reservoir (interior bag 22) is formed of polypropylene (PP).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bottle of Baker in view of Chauhan with the material selection of Hamamoto as a simple substitution of one material for another to form a squeeze bottle capable of administering droplets MPEP 2143 I.
Regarding Claim 17, Baker in view of Chauhan teaches the ophthalmic product of claim 1.
Baker fails to teach the reservoir material.
Hamamoto teaches an eye drop dispensing container (Abstract) wherein
the reservoir (22) comprises glass [0033].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bottle of Baker in view of Chauhan with the glass of Hamamoto to utilize the desirable properties of higher transparency and lower water permeation [0033].
Conclusion
This is a continuation of applicant's earlier Application No. 18363223. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). 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 HANS KALIHER whose telephone number is (303)297-4453. The examiner can normally be reached Monday-Friday 08:00-05:00 MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached on (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HANS KALIHER/ Examiner, Art Unit 3781
/SARAH AL HASHIMI/ Supervisory Patent Examiner, Art Unit 3781
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