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 .
Applicants' arguments, filed April 13, 2026, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
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) 1 – 4 and 9 – 11 were rejected under 35 U.S.C. 103 as being unpatentable over Melles et al. (US 2013/0045167) in view of Li et al. (Br J Ophthal, 2003), Fox (WO 2014/123844), Vowles (US 2013/0312897) and Coroneo (US 6,372,449). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed January 23, 2026 and those set forth herein.
As to the new claim language setting forth the comparison for the staining contrast, this result necessarily arises from the ingredients in the composition and compositions having the claimed ingredients are rendered obvious by the combined teachings of the applied prior art as discussed in greater detail in the January 23, 2026 Office Action. "A 'whereby' clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim." Texas Instruments, Inc. v. International Trade Comm., 988 F.2d 1165, 1172 (Fed. Cir. 1993). See also Minton v. National Assoc. of Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003) ("A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.") MPEP 2111.04 The wherein clause merely characterizes the results of other limitations present in the claims so this "wherein" clause is not entitled to weight in construing the claim and does not patentably distinguish the instant claims over the applied prior. Even if it was given weight, any increase in staining contrast of the dye would be sufficient to meet the limitation.
Applicants traverse this rejection on the grounds that PEG (polyethylene glycol) is the preferred density increasing agent in the Melles, only showed a 0.7 fold increase in staining when added along with BBG (Brilliant Blue G), a decrease in contrast over TB (Trypan blue) alone while those comprising diglycerol (DG) and BBG showed an increase in staining compared to compositions with only TB, a critical and unexpected distinction that the prior art fails to teach or suggest. Various dye combination with 5% diglycerol achieved significant increases in staining contrast (all data from table at ¶ [01122] of the PGPub of the instant application/p 16 – 17 of the specification as filed).
Melles also teaches that the preferably the density increasing compound does not, or at least significantly does not, affect the staining properties of the vital dye but does not disclose that the preferred PEG actually negatively affects the staining contrast. Despite Fox disclosing diglycerol for use in compositions for cytological staining, increased staining in ophthalmic compositions is not taught or suggested. The disclosure in Vowles relates to an entirely different fields and does not teach or suggest any effecting on staining contrast in ophthalmic applications. One of ordinary skill would have selected PEG as the density increasing agents given the teachings of preferred PEG molecular weights and that PEG may have an advantage of decreasing or at least not increasing the dye degradation rate. There would be no motivation to substitute diglycerol for PEG and certainly no expectation that doing so would result in improved staining contrast. Data from the specification for the density and viscosity of diglycerol and PEG3350 in the specification was taught, showing that diglycerol achieves a higher density and lower viscosity compared to PEG, a further unexpected advantage. The unexpected results are sufficient to rebut the prima facie case of obviousness.
These arguments are unpersuasive. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). (MPEP 2123). Furthermore, “the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). MPEP 2123, emphasis added. That PEG is preferred does not mean that there is no motivation to use other materials that are known in the prior art and to those of ordinary skill in the art to alter the density of the composition. Ingredients can have simultaneous advantages and disadvantages when added to a composition and that does not mean that there is no motivation to replace one ingredient with another. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Amongst the requirements for evidence of unexpected results is that the data must be reasonable commensurate in scope with the claims. The data only relates to the addition of 5% diglycerol, while the claims recite either diglycerol or triglycerol in a range of 0.1 – 25% (v/v) although narrower ranges such as 3% - 6% (v/v) are recited in a dependent claim. The claims also only require the presence of one dye with no limits on the amounts in independent clam 1. Dependent claim 9 recites specific dyes and ranges but each range is two orders of magnitude or more. In contrast, all of the data is for compositions that contain two dyes (0.1% TB and varying concentrations of the second dye) and the staining is compared to that of the formulation with no additives such as PEG or diglycerol and the dye Trypan Blue (TB, 0.1%) alone (first column in the referenced table) or added 0.025% BBG and 5% diglycerol (second column in the referenced table). No explanation as how this alleged unexpected result would then behave an expected manner to extrapolate to be reasonably commensurate in scope with the claims. For example, to any dye in any amount and when not in combination with Trypan Blue and when triglycerol or concentrations other than 5% diglycerol are used. No explanation as to why 4% PEG4000 was used compared to 5% diglycerol was set forth. This comparison could be explained if, for example, this resulted in a composition of the same density or viscosity but no such explanation appears in the record. The density of polymer solutions is also dependent on concentration of the material and molecular weight. The results in the table relate to PEG4000, which one of ordinary skill in the art would reasonably expect to have a higher density than the PEG3350 and Applicants, who bear the burden of explaining the evidence offered in support of allegation of unexpected results, have not set forth rationale relating to this different and what the likely density would be and that the density does not explain the differences that were observed. When all of these factors in support of the alleged unexpected results and the prima facie case of obviousness are weighed, the evidence of record in support of unexpected results does not outweigh the prima facie case of obviousness.
Conclusion
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 Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 pm.
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/Nissa M Westerberg/Primary Examiner, Art Unit 1618
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