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 1-12 are pending in the application.
Claims 4-12 are withdrawn.
Claims 1-3 are the subject of this office action.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kameda et al (US 4,780,421; previously cited).
Regarding claim 1, Kameda teaches a biomolecule structure detection probe represented by Formula (P1) wherein Y1 and Y2 each independently represent a divalent linking group; L represents a labeling substance; and A represents a specific binding substance having a specific binding activity to a biomolecule structure (Abstract; Col. 2, Ln. 54-67: label is conjugated to the desired specifically reactive component through a cleavable bond; Col. 3, Ln. 59-64: the substance specifically reactive with the analyte may be an antibody; Col. 4, Ln. 59-64: the cleavable bond of the invention may be used to conjugate a label to the substance specifically reactive with the analyte; Col. 6, Ln. 29-33: the cleavable bond may be a disulfide bond; Col. 8, Ln. 10-21: the conjugates were found to have 1.9 mol fluoresceins per mole F(ab’)2).
Regarding interpretation of claim 1, it is noted that claim 1 lacks a specific transitional phrase (such as “comprising” or “consisting of”) which explicitly or clearly indicates whether the claim should be given an open interpretation (i.e. such that the claimed probe may comprise additional unrecited elements, as would be the case with the transitional phrase “comprising”) or whether the claim should be given a closed interpretation (i.e. such that the claimed probe is limited to the explicitly recited elements of the claim, and may not comprise additional unrecited elements, as would be the case with the transitional phrase “consisting of”). Given this lack of explicit clarity, the claim is interpreted herein to give it its broadest reasonable interpretation, and is therefore interpreted according to the “open” interpretation. As such, a detection probe which comprises the recited formula may read on the instantly claimed probe, even if it also comprises additional unrecited elements. For example, a probe which comprises a specific binding element linked to more than one linker molecule is still understood to read on the instant claim, because it is understood to comprise the recited formula.
However, for the sake of compact prosecution, the closed interpretation is also considered and addressed herein: a batch of conjugate such as the one disclosed by Kameda which has a molar ratio of 1.9 moles of fluorescein-linker (F’) per mole of F(ab’)2 is understood to include conjugates represented by Formula (P1), wherein a single linker molecule is linked to a single molecule of a specific binding substance. That is, 1.9 mol of F’ per mol of specific binding substance represents an average for the batch of conjugates synthesized in the described example, but each individual conjugate present in the batch is understood to comprise a whole number of F’ molecules conjugated to a whole number of specific binding substance molecules, such that a batch with an average of 1.9 linker molecules per specific binding substance molecule can be assumed to comprise at least some conjugates with a single linker molecule linked to a single molecule of specific binding substance, and these conjugates read on the instant claim.
Regarding claim 2, Kameda teaches the biomolecule structure detection probe wherein the specific binding substance is an antibody (Col. 3, Ln. 41-48: the substance specifically reactive with the analyte may be an antibody; Col. 8, Ln. 10-29: F’m-IgE, F’m-goat anti-IgE)
Regarding claim 3, Kameda teaches the biomolecule structure detection probe wherein the labeling substance is a fluorescent dye (Col. 4, Ln. 49-56; Col. 3, Ln, 30-37).
Response to Arguments
Applicant’s arguments filed 14 July 2026 have been fully considered.
Regarding the 102 rejection, Applicant argues that Kameda does not meet the amended independent claim because Kameda discloses conjugates containing 1.9 moles or 5.7 moles of a fluorescein and linker-containing compounds per mole of F(ab’)2, such that these conjugates have multiple linker molecules attached to one antibody fragment, whereas the instantly claimed structure is one linker molecule including a disulfide bond linked to one molecule of a specific binding substance.
This argument is not persuasive because, as noted in the rejection above, the claim language does not explicitly limit the probe to a closed interpretation of the claim, such that the broadest reasonable interpretation of the claim is understood to include probe which comprise the recited formula and which also comprise additional unrecited elements (which would therefore encompass an embodiment wherein a single molecule of a specific binding substance is conjugate to multiple linker molecules.
However, even under a closed interpretation of the claim language, this argument is not persuasive because a batch of conjugate containing 1.9 moles of a fluorescein-linker compound per mole F(ab’)2 is understood to comprise at least some conjugates which comprise one fluorescein-linker molecule linked to one F(ab’)2 molecule, since each conjugate is understood to comprise a whole number of fluorescein-linker molecules linked to a whole number of specific binding substance molecules, such that an average of 1.9 would be assumed to include at least some conjugates which comprise a single linker molecule conjugated to a single specific binding substance molecule, as required by the instant claim. This point is further reflected in Applicant’s Rule 132 Declaration, wherein conjugates having approximately 1.68 linker molecules per antibody molecule are used to support an assertion of unexpected results achieved by the biomolecule structure detection probe of claim 1.
Applicant’s assertion of unexpectedly improved results is not persuasive in overcoming the rejection at least because a showing of unexpected results is irrelevant to a 102 rejection (see MPEP 2131.04).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLIS LUSI whose telephone number is (571)270-0694. The examiner can normally be reached M-Th 8am-6pm ET.
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/ELLIS FOLLETT LUSI/Examiner, Art Unit 1677
/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
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