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 .
Acknowledgments and Claim Status
The Examiner acknowledges receipt of the amendment filed 2/3/2026 wherein claims 1, 3, 5, 12, and 15 were amended and claims 2, 4, 7, 9, 20-24 and 34-58 were canceled.
Note(s): Claims 1, 3, 5, 6, 8, 10-19, and 25-33 are pending.
Priority
This application is a 371 of PCT/US2020/048264 filed 8/27/2020 and PCT/US2020/048264 claims benefit to PRO 62/894,553 filed 8/30/2019.
Note(s): The earliest effective filing date is unclear as the clarity of the pending invention is difficult to ascertain.
Response to Applicant’s Amendment and/or Arguments
The Applicant's arguments and/or amendment filed 2/3/2026 to the rejection of claims 1-12 and 14-19 made by the Examiner under 35 USC 102, 103, 112, and/or double patenting have been fully considered and deemed persuasive-in-part for the reasons set forth below.
102 Rejection
The 102 rejection over Kleinfeld et al (US Patent No. 9,529,003) is WITHDRAWN. In particular, the amendment filed 2/3/2026 has resulting in ambiguity of the claims such that the metes and bounds of the claim are not clear. As a result, the new rejections below are necessary to clear the record and determine exactly what is being claimed and if the newly filed amendment is supported. In addition, while the prior art rejections from the office action mailed 9/4/2025 are withdrawn, those rejections may very well be reinstated once the claims are amended to provide clarity of the invention.
103 Rejection
The 103 rejection over Kleinfeld et al (WO 2013/032953) is WITHDRAWN. In particular, the amendment filed 2/3/2026 has resulting in ambiguity of the claims such that the metes and bounds of the claim are not clear. As a result, the new rejections below are necessary to clear the record and determine exactly what is being claimed and if the newly amended claims are supported. In addition, while the prior art rejections from the office action mailed 9/4/2025 are withdrawn, those rejections may very well be reinstated once the claims are amended to provide clarity of the invention.
Double Patenting Rejections
The nonstatutory double patenting rejections over US Patent Nos: 9,529,003; 10,295,551; and 11,029,320 are WITHDRAWN. In particular, the amendment filed 2/3/2026 has resulting in ambiguity of the claims such that the metes and bounds of the claim are not clear. As a result, the new rejections below are necessary to clear the record and determine exactly what is being claimed and if the newly amended claims are supported. In addition, while the prior art rejections from the office action mailed 9/4/2025 are withdrawn, those rejections may very well be reinstated once the claims are amended to provide clarity of the invention.
112 Second Paragraph Rejections
I. All outstanding 112 second paragraph rejections are WITHDRAWN, except the following. In particular, the rejections are withdrawn because Applicant amended the claims to overcome the rejections.
II. 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 10-15 and 18 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.
Claims 10-15, and 18: The claims are ambiguous because it is unclear what limitations must be met in order for the probe to (1) be configured to bind to an unconjugated isomer of bilirubin; (2) be configure to minimally bind to conjugated bilirubin; (3) be configured to non-binding to Z,E or E,Z photoisomers of bilirubin, to lumirubin, to fatty acids, to any other naturally occurring blood components, and/or to neonatal drugs; (4) not bind to an unconjugated IX-α (Z,Z) isomer of bilirubin or to conjugated bilirubin; and (5) to result in a probe that is not affected by the absorbance of blood components selected from bilirubin and hemoglobin. Thus, the metes and bounds of the claims cannot be ascertained.
APPLICANT’S ASSERTIONS:
In summary, it is asserted that due to the amending of independent claim 1 to recite a first iLBP and a second iLBP peptide having sequence features and selected fluorophores. Applicant then discusses the bilirubin responsive probe and non-responder probes.
EXAMINER’S RESPONSE:
Applicant’s response filed 2/3/2026 was considered and found non-persuasive for reasons of record and those set forth below. In particular, the limitations in the dependent claim are based on active steps and not additional components incorporated into the dependent claims that further limit the product (sensor) of independent claim 1. The use of language such as ‘is configured to bind...’ (see claim 10); ‘is configured to minimally bind...’ (see claim 11); ‘is configured to not bind...’ (see claim 12); ‘ based on an active step from a previous dependent claim (see claim 13); ‘does not bind to...’ (see claim 14); ‘is configured to not bind...’ (see claim 15)’ and ‘wherein the emission intensity...is not affected by ...’ (see claim 18) makes the claim indefinite. According to MPEP 2173.05(p), a single claim directed to both a product and method steps for using such product is indefinite. In particular, the claim is indefinite because while the claim initially sets forth a product, the claim limitation is not directed to the product, but rather to actions involving the product which creates confusion as to when direct infringement occurs. Specifically, it is unclear whether infringement occurs when one has a product comprising the components set forth in independent claim 1 or when elements are configured, bound, or not bound in a particular configuration. Thus, the rejection of claims 10-15 is still deemed proper.
NEW GROUNDS OF REJECTIONS
Written Description Rejection
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 5, 6, 8, and 10-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant is reminded that an inventor is entitled to a patent to protect his work only if he/she produces or has possession of something truly new and novel. The invention being claimed must be sufficiently concrete so that it can be described for the world to appreciate the specific nature of the work that sets it apart from what was before. The inventor must be able to describe the item to be patented with such clarity that the reader is assured that the inventor actually has possession and knowledge of the unique composition that makes it worthy of patent protection. The pending application does not sufficiently describe the invention as it relates to: (1) probes other than those having an configuration MGI-KR14-sustitutions and additions-C2XH11 and (2) probes other than those of Tables 1 (specification, page 37) and Table 2 (specification, page 38). Thus, what the reader gathers from the instant application is a desire/plan/first step for obtaining a desired result. While the reader can certainly appreciate the desire for achieving a certain end result, establishing goals does not necessarily mean that an invention has been adequately described.
While compliance with the written description requirements must be determined on a case-by-case basis, the real issue here is simply whether an adequate description is necessary to practice an invention described only in terms of its function and/or based on a disclosure wherein a description of the components necessary in order for the invention to function are lacking. In order to satisfy the written description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. In other words, the specification should describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that the inventor created what is the claimed. Thus, the written description requirement is lacking in the instant invention since the various terms as set forth above are not described in a manner to clearly allow persons of ordinary skill in the art to recognize that Applicant invented what is being claimed.
112 Second Paragraph Rejections
Claims 1, 3, 5, 6, 8, and 10-19 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.
Claims 1, 3, 5, 6, 8, and 10-19: Independent claim 1 is ambiguous for the following reasons. In lines 3-5, it is disclosed that the first iLBP has a peptide sequence comprising SEQ ID No; 1. At the end of line 5 is the term ‘comprising’ that continues with the phrase through line 7, ‘comprising Arg substituting for fourteen accessible lysines (KR14) having a sequence as set forth in SEQ ID No: 2’. It is unclear what component Applicant is referencing. Is this a ‘further comprising’ portion of SEQ ID No: 1? Applicant indicates that the ‘comprising Arg’ phrase results in SEQ ID No: 2, but does not clearly state which component of the sensor has SEQ ID No: 2.
Also, in lines 11-12, the phrase “no more than 62 amino acid substitutions and additions including a single cysteine’ is vague and indefinite. Is Applicant referring to the bilirubin responsive probe labeled with a first fluorophore, the first iLBP, SEQ ID No: 1, SEQ ID No: 2, the C-terminal double His tag linker, the sensor in general? Initially, it appears that Applicant may be claiming a particular senor with a definite sequence, but the phrase ‘no more than 62 amino acid substitutions and additions including a single cysteine (lines 11-12) opens the claim up to any derivative of the sensor having substitution at any locations. If one has substitutions at any location within the sequence then the result is structures with distinct amino acids sequences that do not necessarily have a common core. There is no portion of the sensor that contains a sequence that cannot have a substitution or addition. Still, there is the question of whether or not the ’62’ in lines 11 is for the term ‘substitution’ or both ‘substitution and additions. Should the phrase be interpreted as ’62 amino acid substitutions and additions total’; ’62 amino acid substitutions and 62 additions’; or ’62 amino acid substitutions’ and an unlimited amount of additions?
In line 21, the phrase ‘no more than three additional amino acid substitutions’ is vague and indefinite. Does the phrase refer to the non-responder probe comprising SEQ ID No: 1, the maximum number of substitutions you may have for positions 72, 73, 74, 126, and 131; the maximum number of substitution to Cys at positions 27, 31, 33, 54, 73, 74, 76, or 98’ or a combination of all the listed options?
Since claims 3, 5, 6, 8, and 10-19 depend upon independent claim 1 for clarity, those claims are also vague and indefinite.
Note(s): For clarity of independent claim 1 (line 10), it is requested that one indicate that MGI is ‘Met-Gly-Ile’.
Applicant’s Election
Once again, Applicant's election without traverse of Group I (pending claims 1-19) filed 6/20/2025 is acknowledged. The restriction requirement was deemed proper and made FINAL.
Applicant’s election of the species filed 6/20/2025 is acknowledged. Specifically, Applicant elected wherein LICOR 700DX (fluorophore); a peptide of SEQ ID NO: 1 (lipid binding protein/peptide); N-terminal addition of MGI (Met-Gly-Ile); cefazolin (neonatal drug); SEQ ID NO: 13 (bilirubin responsive probe); SEQ ID NO: 3 (linker); Ni-polystyrene bead (solid substrate); His-tag (tag); and SEQ ID NO: 28 (non-responder probe) for initial examination.
Initially, Applicant’s elected species was searched. However, no prior art was found which could be used to reject the claims. Thus, the search was expanded and prior art was cited. Currently, the search of the claims was not further extended because the metes and bounds of the claimed invention are not clear.
Withdrawn Claims
Claims 25-33 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Information Disclosure Statement
The information disclosure statements filed 2/3/2026 and 4/6/2026 were considered.
Conclusion
Claims 1, 3, 5, 6, 8, and 10-19 are rejected and claims 25-33 are withdrawn.
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.
Future Correspondences
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D L Jones whose telephone number is (571)272-0617. The examiner can normally be reached M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G. 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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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
April 7, 2026