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 .
Receipt is acknowledged of Applicant’s Amendment filed on 04/01/2026.
Claims 4, 10 have been amended.
Claims 20-21 have been added.
Claims 1-10, 16-21 are pending in the instant application.
Claims 9-10, 16-19, 21 are withdrawn from consideration. Note, new claim 21 is dependent on a withdrawn claim.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112, 2nd paragraph
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.
Claim 20 is 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.
Regarding claim 20, the phrase “preferably” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
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) 1-8, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over YAMAMURA et al (JPH0894826).
YAMAMURA teaches compound 23 (see pg. 9; wherein the compound is provided below with labels):
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The difference between YAMAMURA’s compound and Applicant’s compound is R2, wherein YAMAMURA teaches R2 is C2, but Applicant claims one of the R2 has to be C1 or C3-8, which is only a difference of one CH2 group. Additionally, in Applicant’s claim 8, R1 is different by a single CH2 group.
It would have been obvious to one of ordinary skill in the art to expect similar beneficial results with compounds having only an additional -CH2- group, which would be going from a C2 (ethyl) as taught by YAMAMURA to C1 (methyl) or C3 (propyl). Case law holds that homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). Thus, it would be presumed that the addition/subtraction of a single -CH2- group would possess similar properties.
Response to Arguments
Applicant argues that The Examiner purports that the difference between Y AMAMURA and the compounds as claimed would merely be one additional CH2 group and therefore the skilled person would expect similar beneficial results with compounds that are allegedly so similar. Applicant respectfully disagrees. The specification demonstrates that all exemplified compounds (1) to (8) do not stain living cells; (see the application as filed on page 8, lines 15-16 and lines 18-19 (Aliving < 0.0629)). Moreover, compounds (1) to (8) show an unexpectedly high ability to stain the ILM relative to the BBG derivatives EBBG, PBBG and BBBG disclosed in the art, (see the application as filed on page 8, lines 10-13). This combination of high ILM staining ability while not staining living cells represents an unexpected result.
The Examiner finds Applicant’s argument unpersuasive, because in order to overcome a prima facie case of obviousness, it is incumbent upon the Applicant to provide comparative test evidence that demonstrates unexpected superiority of the claimed compositions versus the closest prior art compositions, and not simply an advantage predictable from the prior art. See In re Chapman, 148 USPQ 711, 715 (CCPA, 1966). Additionally, such proffered comparisons must be commensurate in scope with the breadth of the claims. See In re Clemens, 206 USPQ 289, 296 (CCPA, 1980) and In re Coleman, 205 USPQ 1172, 1175 (CCPA 1980). In this instance, claim 1 encompass more than compounds 1-8 in Applicant’s specification. Additionally, does Applicant’s specification have any comparison data for ILM, besides the alleged unexpectedly high ability to stain the ILM relative to the BBG derivatives EBBG, PBBG and BBBG disclosed in the art, (see the application as filed on page 8, lines 10-13)?
Applicant argues that the specification further explains that the staining of living cells increases with increasing size of the R3 group (Aliving = 0.0724 for EBBG; 0.1331 for PBBG; 0.1491 for BBBG), see Table 2 on page 22, lines 5-10.
The Examiner finds this argument unpersuasive and confusing, because Applicant’s compound 1-8 only has R3 = H in Table 2 (see Table 2 provided below).
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Applicant argues that YAMAMURA does not suggest that increasing the number of carbon atoms comprised in R1, R2 or R3 could yield compounds that do not stain living cells. The compounds as claimed have increased ability for staining the ILM and which do not stain living cells. Indeed, for all (1)-(8) Aliving < 0.07. The structural difference between the BBG derivatives known in the art (BBG, EBBG, PBBG, BBBG) and the compounds as claimed is the variation of RI and R2 relative to BBG in (1)-(8) instead of the variation in R3 in BBG, EBBG, PBBG, BBBG. This specific structural modification results in the unexpected combination of properties.
The Examiner finds this argument unpersuasive, because Applicant’s claims are directed to a compound, not to a method of staining living cells.
Applicant argues that interestingly, in the compounds as claimed, wherein one of RI and R2 has more than two carbon atoms and the other one has exactly two carbon atoms ((3), (4), (5), (7), (8)), have a high staining ability. In other words, the compounds wherein RI or R2 has been elongated with respect to the ethyl group in BBG, show a high staining but do not stain living cells (see application as filed on page 22, lines 15 - 20). The specification further demonstrates that compound (6) has an increased ability to stain the ILM compared to BBG, whereas compound (8) demonstrated an increased ability to stain the ILM compared to compound (6), see page 9, lines 10-20. Additionally, compounds (5), (6), (7) and (8) according to the invention have a comparable toxicity relative to BBG, as expressed by the survival of ARPE-19 cells after exposure, see application as filed on page 11, lines 10-15. This demonstrates that the claimed compounds maintain acceptable safety profiles while achieving their unexpected staining properties.
The Examiner finds this argument unpersuasive, because as discussed above, in order to overcome a prima facie case of obviousness, it is incumbent upon the Applicant to provide comparative test evidence that demonstrates unexpected superiority of the claimed compositions versus the closest prior art compositions, and not simply an advantage predictable from the prior art. See In re Chapman, 148 USPQ 711, 715 (CCPA, 1966). Additionally, such proffered comparisons must be commensurate in scope with the breadth of the claims. See In re Clemens, 206 USPQ 289, 296 (CCPA, 1980) and In re Coleman, 205 USPQ 1172, 1175 (CCPA 1980). In this instance, claim 1 encompass more than compounds 1-8 in Applicant’s specification.
Applicant argues that Y AMAMURA is directed to ink compositions for producing colour filters for liquid crystal display devices. YAMAMURA is silent on any ophthalmic applications, cell staining properties, or the ability to selectively stain ophthalmic structures without staining living cells. There is no disclosure in Y AMAMURA regarding the specific property of not staining living cells while maintaining high ILM staining ability while maintaining acceptable safety profiles. The Examiner's reliance on the homolog presumption is considered misplaced because the claimed compounds exhibit unexpected results that overcome this presumption. The specification demonstrates that compounds (1)-(8) as recited by claim 1 achieve the unexpected combination of not staining living cells (Aliving < 0.07) and high ability to stain the ILM. This combination of properties would not have been predictable from YAMAMURA, which is entirely silent on cell staining behaviour and ophthalmic applications. A person of ordinary skill in the art would not have had a reasonable expectation that modifying Y AMAMURA' s compound would yield compounds suitable for ophthalmic surgery that selectively stain ophthalmic structures without staining living cells.
The Examiner finds this argument unpersuasive, because as discussed above, (1) Applicant’s claims are directed to a compound, not to a method of staining living cells; (2) in order to overcome a prima facie case of obviousness, it is incumbent upon the Applicant to provide comparative test evidence that demonstrates unexpected superiority of the claimed compositions versus the closest prior art compositions, and not simply an advantage predictable from the prior art. See In re Chapman, 148 USPQ 711, 715 (CCPA, 1966); and (3) such proffered comparisons must be commensurate in scope with the breadth of the claims. See In re Clemens, 206 USPQ 289, 296 (CCPA, 1980) and In re Coleman, 205 USPQ 1172, 1175 (CCPA 1980). In this instance, claim 1 encompass more than compounds 1-8 in Applicant’s specification.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
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, Michael Hartley can be reached at (571) 272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAKE M VU/Primary Examiner, Art Unit 1618
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