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 the Claims
Claims 1-4, 12, 14, 18, 20-22, 29, 30, and 36-44 are pending.
Claims 43 and 44 are withdrawn from consideration as directed to a non-elected invention.
Claims 1-4, 12, 14, 18, 20-22, 29, 30, and 36-42 are presented for examination and rejected as set forth below.
Claim Interpretation
Applicants claims as amended are directed to nanoemulsions containing phospholipids in an amount of between 0.1-5% w/v, vitamin D in concentrations of between 0.02-2% w/v, where the phospholipids and vitamin D are present in a ratio of at least 3:1, where the nanoparticles of the nanoemulsion have a diameter of between 100-300 nanometers and the composition, when used, provides for a tear film thickness which permits light absorbance at a particular wavelength. Once more into the breach we go: this revision to the claim language perpetuates applicants ongoing struggle comprehending the objective breadth of the invention they claim. As worded, it is reasonably interpreted as the recitation of a property the composition is to possess: an emulsion whereby the ability to absorb electromagnetic radiation having a wavelength of between 220-520nm is present when applied to the eye. Given the wavelength range, this is understood to encompass each of the UVA, UVB, UVC, violet, and blue portions of the electromagnetic spectrum. Applicants are, yet again, reminded that it was well known at the time the instant application was filed that nanoemulsions inherently possess the capacity to absorb electromagnetic radiation in the UV-visible range simply by virtue of the properties of the particulate suspended phase, including the particulate size of the suspended phase. See Withida Chantrapornchai, et al, Influence of Droplet Size and Concentration on the Color of Oil-in-Water Emulsions, 46 J Agric. Food Chem. 2914, 2917 (1998)(demonstrating that emulsions increasingly absorb electromagnetic radiation in the range of 200-500nm as emulsion droplet size decreases). Art which establishes an expectation that a component of the composition, or the composition itself by virtue of the particulate size of the emulsion present, will absorb light within the wavelengths recited will continue to address these limitations. Applicants attention is particularly drawn to the teachings of The Bourdillon reference concerning the UV absorption spectrum of Vitamin D to further bolster the Examiner’s position. Dependent claims 2, 3, 12, 22, and 36 narrow the amount of Vitamin D present or specify that the composition does not comprise a liquified or compressed gas propellant. Claim 14 specifies that the composition is capable of being administered onto the corneal tissue of the subject. The examiner considers an “eye drop” type formulation sufficient to address this limitation, as has been specifically added via new Claims 40 and 41. Claim 18 narrows the concentrations of vitamin D present in the composition, but specifies that the composition is formulated in a manner to provide for contact with the corneal tissues for at least 1 minute, with dependent Claims 20 and 21 narrowing the duration of contact with the corneal tissue. Claim 29 requires the composition be minimally irritating, and Claim 30 that the composition be included in a device. Claims 37 and 38 require that the compositions of Claims 1 and 18, respectively, form a tear film: applicants are reminded that claim language describing the manner in which a composition may be used does nothing to limit the scope of the composition claimed. Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003)(indicating that a recitation of an intended use will not limit the scope of the claim because it merely defines a context in which the invention may operate). Claim 39 requires that the composition be hypotonic.
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.
Claims 1-4, 12, 14, 18, 20-22, 29, 30, 36-38, and 40-42 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (U.S. PGPub. 2005/0026877), in view of Ketelson (U.S. PGPub. 2011/0136912), as evidenced by R. B. Bourdillon, et al, The Absorption Spectrum of Vitamin D, 104 Roy. Soc. Proc. B. Plate 36, pg. 561 (1929)), and Withida Chantrapornchai, et al, Influence of Droplet Size and Concentration on the Color of Oil-in-Water Emulsions, 46 J Agric. Food Chem. 2914, 2917 (1998).
Chen describes emulsions of Vitamin D compounds. [0024]. Chen establishes these emulsions are to combine a lipophilic phase, one or more surfactants, an active vitamin D component, and water. [0027]. Chen indicates the emulsion droplets should possess droplet sizes in the range of between about 200-300nm, overlapping and therefore rendering obvious the limitations of Claims 1 and 18. [0032]. Chen indicates that the emulsions are to possess an absorbance at 400nm using spectrophotometry recited by Claim 11, addressing limitations of Claims 1, and 4. [0027; 0035; 0116]. The examiner notes that the vitamin D which is to be included in these compositions inherently possess an absorption spectrum having absorption peaks at approximately 280 and 270 nm. Bourdillon, pg. 566. Phospholipids of Claims 1 and 18 represent exemplary surfactants useful in such emulsions. [0060]. These surfactants are described as being included in the emulsions in concentrations of about 1-90%, or 5-85% by weight of the composition. [0076]. These values either overlap or otherwise render obvious the w/v concentrations of the instant claims. See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”); Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (indicating that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating 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.). Vitamin D is to represent between about 0.01-15% by weight of the composition, again either overlapping or otherwise rendering obvious the concentrations of Claims 1-3, 18, and 36 by virtue of it being the active ingredient recited by the teachings of Chen. [0077]; See Peterson, Titanium Metals, and Aller, supra. Chen indicates that the relative proportions of ingredients in the compositions of the invention will, of course, vary considerably depending on the particular type of composition concerning, depending on the particular function of the ingredient concerned. [0074]. While the “at least 3:1” ratio of phospholipid to vitamin D recited by the present claims is not specified, by teaching ranges which include ranges of phospholipid to vitamin D which overlap the 3:1 of the instant claims and motivating the artisan to optimize these relative amounts of components, the burden is shifted to the applicants to demonstrate a non-obvious difference. “The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Chen indicates that he emulsions described can take the form of ophthalmic appropriate dosage forms including eye drop, eye lotion, or eye gel formulations. [0071]. Any of a variety of additional components find a place in these compositions according to the teachings of Chen, including additional active agents as well as thickening agents to provide for a sustained release effect. [0044-46; 0068-70].
Ketelson relates to emulsions specifically formulated for ophthalmic use. (Abs.). These emulsions may be employed for, among others, vitamin delivery and contain, like Chen, a combination of aqueous phase, oil phase, phospholipids and mucoadhesive polymers to provide emulsions with particle sizes of no greater than 500nm, but typically more than 100nm, defining a range overlapping and therefore rendering obvious the limitations of the instant claims. [0012-15], see Peterson, supra. Preferable concentrations for the phospholipids in the ophthalmic emulsions fall within the range of the 0.1-5%w/v of the present claims. [0029], see Peterson, supra. Vitamin D is recited among the ophthalmic agents useful in the ophthalmic emulsions recited, with concentrations of the active present in such emulsions falling within the range of about 0.005-2% w/v, overlapping and rendering obvious the concentrations of the instant claims. [0038-40], see Peterson, supra. These emulsions are typically provided in an eye dropper for application to the surface of the eye and are shown to alleviate symptoms of dry eye, which the examiner considers sufficient to address the corneal tissue administrability, corneal tissue irritation, and medical device limitations of Claims 14, 29, 30, 40 and 41. [0044]. Ketelson indicates that the inclusion of the mucoadhesive polymers serves to increase the residence time of the emulsion on the ocular surface to improve efficacy of the eye drops so provided. [0045]. While this does not specify the timeframes or the means of their determination specifically recited by each of Claims 18, 20, and 21, by indicating the benefits associated with prolonged contact time of the ophthalmic emulsions with the ocular surface, the skilled artisan would appreciate the residence time is a result-effective variable suited for optimization through little more than routine experimentation, and obvious thereby. See Aller and Spada, supra.
The art at the time of the instant application then suggests providing eyedropper devices containing ophthalmic nanoemulsions of particle sizes overlapping those of the instant claims. The art suggests these nanoemulsions contain phospholipids in concentrations overlapping those of the instant claims and active agents such as vitamin D of the instant claims also in concentrations overlapping those of the instant claims, thereby necessarily including ratios of phospholipid to vitamin D overlapping those of the instant claims. The art provides teachings suggesting that these emulsions would possess light absorption wavelength properties addressing those of the instant claims. The instant claims therefore appear to represent little more than an arrangement of old elements with each performing the same function it had been known to perform and yielding no more than one would expect from such an arrangement, and prima facie obvious thereby. KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)) (indicating that “when the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.”).
Claims 1-4, 12, 14, 18, 20-22, 29, 30, and 36-42 are rejected under 35 U.S.C. 103 as being unpatentable over Chen, Ketelson, Bourdillon, and Chantrapornchai as applied to Claims 1-4, 12, 14, 18, 20-22, 29, 30, 36-38, and 40-42 above, and further in view of Ellis (U.S. PGPub. 2013/0116219).
Chen, Ketelson, Bourdillon, and Chantrapornchai, discussed in greater detail above, suggests providing eyedropper devices containing ophthalmic nanoemulsions of particle sizes overlapping those of the instant claims, containing phospholipids in concentrations overlapping those of the instant claims and active agents such as vitamin D of the instant claims also in concentrations overlapping those of the instant claims, thereby necessarily including ratios of phospholipid to vitamin D overlapping those of the instant claims. The art provides teachings suggesting that these emulsions would possess light absorption wavelength properties addressing those of the instant claims.
None of the Chen, Ketelson, Bourdillon, and Chantrapornchai references specifically advocate rendering these eye drop formulations hypotonic.
This is cured by the teachings of Ellis, which establishes that rendering eye drop compositions hypotonic carries with it the beneficial property of combating any hypertonicity of tears cause by evaporation or disease of the ocular surface to which they are applied. [0052].
It would have been prima facie obvious to have made the ophthalmic eye drop compositions suggested by the combined teachings of Chen, Ketelson, Bourdillon, and Chantrapornchai hypotonic because doing so would serve to combat any hypertonicity of tears caused by evaporation and/or disease. It must be remembered that the strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95 (Fed. Cir. 1983). Because Ellis establishes a benefit to be observed by formulating an eye drop to be hypotonic, the skilled artisan is provided the motivation to do so.
Response to Arguments
Applicant's arguments filed 8 July 2025 have been fully considered, but they are not persuasive.
Applicants assert that insufficient weight has been afforded applicants claim language concerning the UV wavelengths to be absorbed by the tear film thicknesses obtained by the use of the compositions claimed.
Nothing could be farther from the truth.
The Examiner has repeatedly provided applicants objective evidence supporting the conclusion that the state of the art at the time applicants filed the instant application appreciated that nanoemulsions containing the components claimed, as well as the particularly claimed suspended emulsion particle size, will necessarily possess the ability to absorb electromagnetic radiation within the claimed ranges. This is because the Chen reference explicitly states this is a property possessed by their compositions. In addition, the record establishes the fact that the vitamin D included in the composition necessarily possess UV absorption peaks within the range claimed. This knowledge imparts to the skilled artisan the understanding that the claim language concerning the claimed emulsion’s ability to absorb electromagnetic radiation within the wavelengths claimed is a property which a skilled artisan would expect to observe from such a composition, and cannot therefore serve to establish the nonobviousness of such a composition.
Applicants assertion that absorbance properties of a bulk emulsion and that of a thin film differ is unsupported by objective evidence and per se unpersuasive as a result. See In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (indicating that "[a]n assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness.").
Applicants repeat their arguments concerning the probative value of the data presented in the application. Applicants arguments are no more persuasive upon their repetition than when initially presented. As was set forth previously, the data relied on by applicants in their response fails to establish anything other than what the skilled artisan would expect to see from a vitamin D nanoemulsion. “Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof.” In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967). Figure 10 appears to demonstrate that increasing concentrations of Vitamin D in a nanoemulsion results in a greater absorbance of ultraviolet light which, given the known capacity of Vitamin D to absorb ultraviolet radiation, cannot serve to patentably distinguish the compositions claimed from the prior art. Figure 11, despite applicants assertion, does not appear to demonstrate a synergistic absorbance of UV light when vitamin D is added to a nanoemulsion carrier; the data provided, such as it is, appears to show a barely additive absorbance is achieved by combining the vitamin D and nanoemulsion carrier. However, if an applicant merely submits evidence to establish the obtention of a result which would have been expected based upon the knowledge of the worker in the art, the evidence merely buttresses the Examiner’s case for obviousness. In re Skoll, 523 F.2d 1392, 187 USPQ 481, 484 (CCPA 1975). In addition, the advantage relied upon must be a significant advantage. See In re Nolan, 553 F.2d 1261, 193 USPQ 641 (CCPA 1977). The evidence relied upon should establish “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.” Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength “are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration.”).
Applicants arguments concerning Chen, Ketelson, Bourdillon, and Chantraporchai are unpersuasive, as none of the references address the alleged shortcomings of the Examiner’s prima facie case.
As has been pointed out above, there are no such shortcomings with the Examiner’s position.
For at least these reasons, applicants arguments are unpersuasive.
Conclusion
No Claims are allowable.
THIS ACTION IS MADE FINAL. 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 SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614