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 . 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.
Status of Claims
Claims 24, 26-28, and 31-45 are pending. Claims 25 and 29-30 are canceled. Claims 24, 26-28 and 31-37 are withdrawn. Claims 38-45 are under examination.
Election/Restrictions
Applicant’s election without traverse of Group III (claims 38-45) in the reply filed on 09/25/2025 is acknowledged.
Claims 24, 26-28 and 31-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking 6claim. Election was made without traverse.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Claim 41 in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim 41 has invoked 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph and the broadest reasonable interpretation of a claim element is limited by the description in the specification. The specification has disclosed an amino group, NH2, OH, COOH, an activated carboxylic acid, SH, iodoacetyl, carbonyl, a hydrazide group, a azido, or a strained alkyne group for immobilization (at page 5, lines 1-3, filed on 01/07/2022).
Claim Rejections - 35 USC § 112
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.
Claims 41-44 are 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.
Claim 41 has invoked 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph but the claim is unclear to where the structure (1a) comprises this “means” for immobilization. Because said structure do not specify additional attachments at the benzene group and X1 independently contains an amino group, it is unclear whether the “means” is an additional amino group or the existed alternatives for immobilization. If Applicant intended to add, for example, an additional amino group to the structure for immobilization, then how is the structure being conjugated to the additional amino group when the structure is incomplete? Because the general structure (1a) is not a complete structure, the recited structure would also mean that the substituted benzene group is already attached to a support. Claims 42-44 are being rejected for the same reason as they are dependent from claim 41.
Claim 42 recites the limitations of “M, m, p, [IMM] and [SPACER] are as defined above for formula (II)” are unclear to what are the metes and bounds of these variables as the claim is dependent on formula (1a) and formula (II) does not exist in the independent claim. Claim 42 is dependent from claim 38 which has the structure of formula (1a) and formula (1a) does not define these variables. Because this is a product claim, these variables should be clearly recited within the claim or reference from a claim that it is dependent from. Therefore, it is unclear to what represents these variables in the claimed structure. Claims 43 and 44 are unclear because these claims are dependent from claim 42.
Additionally, claim 43 recites the limitations of “said molecule comprises one or several counter-anions selected from the group consisting of perchlorate, tosylate, nitrate, sulphate, sulphonate, thiosulfate, halide, hexafluorophosphate, tetraphenylborate, carbonate, and tetrafluoroborate” are unclear to what molecule is in the claimed structure because claim 42 does not recite “a molecule” nor the structure (claims 38 and 42) has the term molecule. Claim 44 is being rejected as being dependent from claim 43.
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.
Claims 38-45 are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (“Enhanced Cell Death Imaging Using Multivalent Zinc(II)-bis(dipicolylamine) Fluorescent Probes”, Mol. Pharmaceutics, 2013, vol. 10 (no. 9), pgs. 3296-3303, IDS submitted 01/07/2022, cite no. 12).
With respect to claims 38 and 39, Smith teaches a clinical need for imaging technologies that can accurately detect cell death in a multitude of pathological conditions and Zinc(II)-bis(dipicolylamine) (Zn2BDPA) coordination complexes (see abstract). Smith teaches Zn2BDPA has the chemical structure of
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Smith further teaches a probe of Tetra-ZN2BDPA-SR (also see Fig. 1), which is linking four ZN2BDPA groups into one probe. Smith teaches in Fig. 1 X1 is oxygen (O) and linked to a CH2 group in the Tetra-ZN2BDPA-SR and Bis-ZN2BDPA-SR. Smith also teaches ZN2+ in Fig. 1. In particular, Smith teaches benzyl group is connecting the dipicolylamine groups to form ZN2BDPA. It is noted that Smith’s Zn2BDPA would be able to bind to microvesicles as it contains Zinc(II)-bis(dipicolylamine).
Although Smith teaches the Zn2BDPA structure is linking two (2) Zinc(II)-bis(dipicolylamine) groups through a substituted benzene group, Smith does not teach linking at least two sets of Zn2BDPA groups through a substituted benzene group.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have linked the Zn2BDPA complexes as taught by Smith through additional substituted benzene groups because Smith recognizes the use of substituted benzene group as linkage for a plurality of Zin(II)-dipicolylamine groups in probe design. Because Smith, structurally, teaches the substituted benzene group provides the ability to attach a plurality of Zin(II)-dipicolylamine groups to form a functional probe (for example, Fig. 1, Bis-Zn2BDPA-SR), it would have been obvious to the person to have attached additional sets of Zn2BDPA groups through the substituted benzene groups to expand additionally Zin(II)-dipicolylamine functional groups onto the tetra and bis structures. Additionally, Meanwhile, 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).
The person would have a reasonable expectation of success in linking the Zn2BDPA complexes of Smith through the substituted benzene group because the substituted benzene group has been recognized by Smith to conjugate a plurality of Zin(II)-dipicolylamine groups to form a functional probe for detection.
With respect to claim 40, Smith teaches the tetra-Zn2BDPA-SR and bis-Zn2BDPA-SR, which would read on dendrimer. As stated above, because Smith, structurally, teaches the substituted benzene group provides the ability to attach a plurality of Zin(II)-dipicolylamine groups to form a functional probe (see Fig. 1, Tetra-Zn2BDPA-SR and Bis-Zn2BDPA-SR), it would have been obvious to the person to have produced 3,5-di(hydroxymethyl) phenol or 3,5 dialkylphenol through the addition of the substituted benzene group.
With respect to claim 41, Smith teaches in Fig. 1 at thiol, carboxyl and amino groups, which would read on a means for immobilization on a support attached at the extremity of a spacer chain, as squaraine rotanane of Smith is a support.
With respect to claim 42, Smith teaches in Fig. 1 O group as linkage. Note that based on the modification above, it would have been obvious that X1-X3 are all O group linkages. Also, the recitations of M, m, p, [IMM] and [Spacer] are as defined above for formula (II) does not provide any limitation to these variables. Thus, the structures in Fig. 1 teach the claimed structures.
With respect to claim 43, Smith teaches in Fig. 1 [IMM]-[SPACER] has NH(CH2)r wherein r is 2. However, Smith does not teach NH2. It would have been obvious to have produced NH2 if the linker is not attached covalently. Meanwhile, homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by a hydrogen group) 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).
With respect to claim 44, Smith teaches in Fig. 1 [IMM]-[SPACER] has NH(CH2)r wherein r is 2. However, Smith does not teach NH2. It would have been obvious to have produced NH2 if the linker is not attached covalently. 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). Meanwhile, it would have been obvious to have added additional hydrocarbon groups because Smith teaches hydrocarbon groups linking oxygen and amine groups. Without unexpected results, it would have been obvious to have modified additional hydrocarbon groups because they are effective in extending the probe.
With respect to claim 45, Smith teaches Zn2BDPA coordination complexes are covalently conjugated to squaraine rotaxane (see structures of Fig. 1), which is a support.
Conclusion
No claim is allowed.
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/N.P.N/Examiner, Art Unit 1678
/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678