DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/26/2025 has been entered.
Status of Application
The response filed 06/26/2025 have been received and carefully considered. The response affects the instant application accordingly:
Claims 14, 19, 28-29, 33, 36 have been amended.
Claim 34 is cancelled.
Claim 37-43 have been added.
Claims 14-16, 19, 22, 24, 26-29, 33, 35-43 are pending.
Claim 26 is withdrawn from further consideration by the examiner being directed to the non-elected Group.
Claims 14-16, 19, 22, 24, 27-29, 33, 35-43 are present for examination at this time.
All grounds not addressed in the action are withdrawn or moot as a result of amendment.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Current Grounds of Rejection and Objection
Claim Objections
Claims 38, 40 are objected to because of the following informalities:
Claim 38 recites the phrase “sodium hyaluronate” which is improper as while genus names in a scientific name should be italicized, “hyaluronate” is not a scientific genus wherein the term should not be italicized. Appropriate correction is required.
Claim 40 recites the phrase “hydroxypropyl cellulose” which is improper as while genus names in a scientific name should be italicized, “hydroxypropyl cellulose” is not a scientific genus wherein the term should not be italicized. Appropriate correction is required.
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.
Claims 14-16, 19, 22, 27-29, 33, 35-37, 41-43 are rejected under 35 U.S.C. 103 as being unpatentable over Mangiafico et al. (U.S. Pat. Pub. 2013/0108674) in view of Liang et al. (U.S. Pat. Pub. 2013/0251666) and Jauw (U.S. Pat. 5,178,853).
It is noted that the term “aqueous phase” is not merely water as it is broad and embraces components that may be present within the water (aqueous phase).
Rejection:
Mangiafico et al. teaches an ophthalmic self-emulsifying microemulsion composition such as tear substitute containing d-α-tocopheryl polyethylene glycol 1000 succinate (TPGS, emulsifier), an oil component consisting of medium chain triglycerides (MCT, oil phase), and an aqueous phase (abstract, claim 1). The TPGS is 0.01-10wt.% and the weight ratio of MCT to TPGS is from 1:1 and 1:4 (which is about 0.01-10%, claims 1 and 9, [37, 47]); specific embodiments include the TPGS at 1-2wt.% and the MCT at 0.25-1% (claim 3). The medium chain triglycerides consist of a mixture of fatty acids with 6-12 carbon atom chains (C6=caproic acid, C8=caprylic acid, C10=capric acid, C12=lauric acid), and commercial products are Miglyol® and TCM® [23]. Composition forms include eye drops ([40], an ophthalmic composition is acceptable/tolerable for being in the eye) and that the composition can be formulated without an active as a tear substitute (claim 9, abstract, [28]). Mangiafico et al. teaches that the composition may include additional components such as a buffer like a phosphate buffer, osmotic agents (osmotizing agents), antimicrobials, and polysaccharides like products based on hyaluronic acid and cellulose derivatives (polymers/viscosity agents/viscosizers [42, 47-48], claims 6-9). The buffer can be a phosphate buffer and the pH is from 5.5-7.2 [49]. The osmotic agents include glycerol and sodium chloride and mixtures thereof [48].
Mangiafico teaches Example 5 which is an ophthalmic antioxidant formulation where the antioxidant includes ascorbic acid and reduced glutathione which are known to be water soluble (in aqueous phase) with glycerol (in aqueous phase), disodium phosphate (in aqueous phase), water, vitamin E TPGS, and MCT (composition consisting of an aqueous phase, TPGS (at 2% falling within the claims), and MCT (at 0.6% falling within the claims, [73-75]). Mangiafico also teaches that the formulation can be a tear substitute with no actives (abstract, claim 9, see full document specifically areas cited).
While Mangiafico does not exemplify sodium chloride or expressly teach the exact claimed values for the pH and some dependent TPGS ranges; Mangiafico teaches the inclusion of osmotic agents (osmotizing agents) such as glycerol and sodium chloride and mixtures thereof wherein the exemplification of the teaching of sodium chloride with glycerol (i.e. Example 5) is prima facie obvious with a reasonable expiation of success. Additionally, the dependent values for TPGS are encompassed by the general range taught by Mangiafico wherein optimization within the taught range is not inventive as a means to attain the desired therapeutic effect, and the values for the pH overlap those taught by Mangiafico where even a slight overlap in range establishes a prima facie case of obviousness and would be obvious to modify the amount before the effective filing date of the claimed invention to attain the desired therapeutic effect, absent evidence of criticality or unexpected results.
Mangiafico et al. does not teach the inclusion of povidone-iodine (PVP-I) or iodine but does expressly teach the inclusion of antimicrobial agents (preservatives).
Liang et al. teaches that povidone-iodine is known to be a preservative in ophthalmic compositions and can be used at 0.2-1.5% in a composition - specifically citing the specific concentration of 0.5%, and has antimicrobial and antioxidant properties [11, 15-16].
Jauw teaches that it is known that having a pH from 5.5-6.5 and the inclusion of potassium iodide or potassium iodate to have 0.01-0.1% available iodine (both salts of iodine, exemplified about 0.03wt.%) further improves the stability of an ophthalmic compositions containing PVP-I (Col. 2 line 51-64, Col 3 line 9-35, claim 11). Jauw teaches this pH range to be desirable for PVP-I with the additional iodine as the iodine would decompose over 6.5. Jauw also teaches that certain packaging and components can extend the shelf life of ophthalmic compositions containing PVP-I and preferred ophthalmic packaging includes a bottle of glass type I with a dropper of polypropylene, polyethylene and/or polytetrafluoroethylene coated bromobutyl rubber as it can extend the shelf life of the composition 1-2 years at room temperature (Col. 1 line 57-Col. 2 line2).
Wherein as Mangiafico et al. teaches that the composition can include antimicrobial agents it would be obvious to before the effective filing date of the claimed invention to include PVP-I and iodide like potassium iodide as suggested by Liang and Jauw and produce the claimed invention; as it is prima facie obvious to incorporate a known antimicrobial preserving agent like PVP-I for its known purpose at its useful concentrations such as 0.5% with a reasonable expectation of success to the formulation such as in Example 5 or the taught tear substitute formulation in Mangiafico, and to also include the iodide like potassium iodide (and the bottle packaging) to further improve the stability of an ophthalmic compositions containing PVP-I as it is prima facie obvious to incorporate components like PVP-I that extends the shelf like of a product and the stability of PVP-I with a reasonable expectation of success.
It is also prima facie obvious to not only to optimize within the pH range of Mangiafico as addressed above - but also to optimize within the smaller pH range of 5.5-6.5 as Jauw teaches this pH range to be desirable for PVP-I with the additional iodine as the iodine would decompose over 6.5, and arrive at the overlapping values with a reasonable expectation of success absent evidence of criticality for the claimed range.
Response to Arguments:
Applicant’s arguments are centered on the assertion that the use of sodium chloride in conjunction with glycerol is not taught or suggested in Mangiafico, Liang, Jauw or any other prior art of combination there; and asserts that one would have not motivations to modify the prior art reference to achieve the claimed composition with the recited surfactant and iodide salt and pH. Applicant also asserts that new claims recite buffers and viscosity agents/viscosizers which are not in the prior art references. Applicant also alleges that claims 14, 33, 36 and its dependent claims are allowable.
This is fully considered but not persuasive. Mangiafico et al. does teach that the composition may include osmotic agents (osmotizing agents) like glycerol and sodium chloride and mixtures thereof; wherein the exemplification of the taught osmotic agent mixtures like glycerol and sodium chloride as taught by the prior art is prima facie obvious to one of ordinary skill in the art with a reasonable expectation of success absent evidence of criticality. As Mangiafico et al. also teaches that the composition can include antimicrobial agents and it is prima facie obvious to incorporate a known antimicrobial preserving agent like PVP-I at its known concentration and an iodide salt like potassium iodide to further improve the stability of an ophthalmic compositions containing PVP-I as it is prima facie obvious to incorporate components like PVP-I and potassium iodide that extends the shelf like of a product and the stability of PVP-I with a reasonable expectation of success. Contrary to Applicant’s assertion, Mangiafico does expressly teaches the presence of buffers like phosphate buffers and polymers/viscosity agents wherein their inclusion is taught.
Accordingly, the rejection stands and the claims are not allowable.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Mangiafico et al. (U.S. Pat. Pub. 2013/0108674) in view of Liang et al. (U.S. Pat. Pub. 2013/0251666) and Jauw (U.S. Pat. 5,178,853) as applied to claims 14-16, 19, 22, 27-29, 33, 35-37, 41-43 above, further in view of Geresheimer (Pharmaceutical Primary Packaging Made of Glass).
Rejection:
The teachings of Mangiafico et al. in view of Liang et al. and Jauw are addressed above, including that it is known that certain packaging and components can extend the shelf life of ophthalmic compositions comprising PVP-I. The preferred ophthalmic packaging includes a bottle of glass type I with a dropper of polypropylene, polyethylene and/or polytetrafluoroethylene coated bromobutyl rubber as it can extend the shelf life of the composition 1-2 years at room temperature (Col. 1 line 57-Col. 2 line2).
Mangiafico et al. in view of Liang et al. and Jauw is silent on the color of the recited packaging (i.e. amber).
Geresheimer teaches that commercially available pharmaceutical glass packaging includes type I bottle forms that can clear and in a range of colors including amber (Page 3 and 24 first column).
Wherein as Mangiafico in view of Liang and Jauw teach the extension of the shelf life of the composition with PVP-I by placing it in the glass bottle packaging, it would be obvious before the effective filing date of the claimed invention to choose a color type for the bottle as suggested by Geresheimer and produce the claimed invention; as it is prima facie obvious to incorporate components (i.e. glass bottle packaging) that extends the shelf like of a product and select a color for the desired profile (i.e. light filtering) and look (i.e. consumer preference) with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are directed to those presented for Mangiafico in view of Liang and Jauw which are addressed above.
Accordingly, the rejection stands.
Claims 38-40 are rejected under 35 U.S.C. 103 as being unpatentable over Mangiafico et al. (U.S. Pat. Pub. 2013/0108674) in view of Liang et al. (U.S. Pat. Pub. 2013/0251666) and Jauw (U.S. Pat. 5,178,853) as applied to claims 14-16, 19, 22, 27-29, 33, 35-37, 41-43 above, further in view of Iwao et al. (EP 0323522).
Rejection:
The teachings of Mangiafico et al. in view of Liang et al. and Jauw are addressed above, including the inclusion of polymers like products based on hyaluronic acid and cellulose derivatives for the composition [48].
Mangiafico et al. in view of Liang et al. and Jauw do not explicit on the form of hyaluronic acid, the amount of hyaluronic acid/hyaluronate, or the dependent claimed polymers, but does teach the inclusion of polymers like products based on hyaluronic acid and cellulose derivatives.
Iwao et al. teaches that hyaluronic acid has excellent viscoelasticity and water-holding properties and can be apply to artificial tears, and can be highly purified as a sodium salt where the sodium hyaluronate can be applied to artificial tears from 0.01-1%, and can be combined with other viscosity agents like polyvinyl alcohol or hydroxyethyl cellulose (Page 1 2nd paragraph-Page 2 last paragraph).
Wherein it would be obvious before the effective filing date of the claimed invention to incorporate the known forms of hyaluronic acid and other useful polymers like hydroxypropyl cellulose (a cellulose) as suggested by Iwao et al. and produce the claimed invention; as it is prima facie obvious to incorporate the know forms of hyaluronic acid and other viscosity agents like polyvinyl alcohol for their known purpose with a reasonable expectation of success. While Iwao does not teach the exact claimed values for the hyaluronate, they are embraced by the taught range wherein it would be prima facie obvious to optimize within the prior art range and arrive at the claimed values as a means of attaining the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed values.
Conclusion
Claims 14-16, 19, 22, 24, 27-29, 33, 35-43 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GIGI GEORGIANA HUANG whose telephone number is (571)272-9073. The examiner can normally be reached Monday-Thursday 9:00-5:00pm.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613
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