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’ response of 1/05/2026 is acknowledged.
Status of Claims
Claims 26-45 are pending in this application. Claims 1-25 have been canceled.
Information Disclosure Statement
Applicant’s information disclosure statement of 9/14/2023 is acknowledged. Initialed copy is enclosed.
Election/Restriction
Applicant's election with traverse of 1/05/2026 is acknowledged. The applicant elected group I (claims 26-35) which is drawn to a lyophilized bead composition.
The traversal is based that applicants state that “the fact that the common technical feature does indeed define over prior art, as will be shown once the examiner makes a formal rejection of the elected claims. Once those claims are shown to be allowable, the examiner must withdraw and reconsider the restriction requirement.” This is not found persuasive. The claims are not allowable and therefore the restriction is maintained.
Claims 36-45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on 1/05/2026. Claims 26-35 are under consideration.
Claim Objections
Claim 26 is objected to because of the following informalities:
Claim 26 is reciting:
A lyophilized bead comprising a reagent and a carbohydrate, the reagent having the general formula (a)-(b)-(c)(I), wherein:
(a) is a fluorescent agent having an emission wavelength of 650- 900 nm,
(c) is a non-fluorescent agent having an absorption wavelength of 650-900 nm, for quenching said emission of said fluorescent agent, and
(b) is a peptide comprising a cleavage site, the cleavage site being specific for a bacterial biomarker, wherein the bacterial biomarker is a bacterial membrane bound protease, bacterial membrane bound transpeptidase, intracellular bacterial protease or extracellular bacterial protease. There is no section (I) in the claim. Appropriate correction is required.
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.
Claim 29 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.
Claim 29 recites the limitation "The method" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim. Furthermore, claim 26 is not a method, claim 26 is drawn to a bead or a product. Therefore, clarification is required to overcome this rejection.
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.
Claims 26-35 are rejected under 35 U.S.C. 103 as being unpatentable over Tolleshaug (US 20110263975) in view of Sabsatian et al. (US 2007275423 A1) and further in view Gazendum (WO 2016/ 076707 A2).
The claims are drawn to:
A lyophilized bead comprising a reagent and a carbohydrate, the reagent having the general formula (a)-(b)-(c), wherein:
(a) is a fluorescent agent having an emission wavelength of 650- 900 nm,
(b) is a non-fluorescent agent having an absorption wavelength of 650-900 nm, for quenching said emission of said fluorescent agent, and
(c) is a peptide comprising a cleavage site, the cleavage site being specific for a bacterial biomarker, wherein the bacterial biomarker is a bacterial membrane bound protease, bacterial membrane bound transpeptidase, intracellular bacterial protease or extracellular bacterial protease, and
the carbohydrate being chosen from the group consisting of monosaccharide, disaccharide, polysaccharide and combinations thereof.
Tolleshaug US 20110263975 (the whole document; claim 1; paragraphs [0134], [0135]) discloses a lyophilized composition comprising a saccharide (i.e. carbohydrate), and a protease activity probe comprising a protease site flanked by a fluorophore and quencher. The fluorophores emit in the range 600-1000 and 500-1200nm (paragraph 0033, 0144 and clam 12 ), which anticipates the range 650-900nm due to the closeness of the lower end-points. Tolleshaug teaches lyophilized compositions comprising a reagent and a carbohydrate ( see para 0033, 0134, 0135), Tolleshaug teaches monosaccharides, disaccharide, polysaccharides ( para 0031, 0129) and limitations of claim 35 dextran, chitosan, glucose, sucrose, maltose, trehalose ( para 0059, 0115, 0129). Tolleshaug teaches linkers and cyanine ( see para 0002, 0012,0018, 0024, 0082, 0083). Tolleshaug teaches bacterial protease as biomarkers see para 0005, 0018,0028, 0037, 0128. Tolleshaug teaches E.coli see para 0099. Tolleshaug do not specifically mention beads.
Sabsatian et al. teach beads (para 0099. 0100. 0102), bacterial protease ( para 0011, 0017, 0083). Additionally, Sabsatian et al. (the whole document; claims 1-22; paragraph [0045]) discloses a method of diagnosing infections in bodily fluids (e.g. wound fluid) by detecting microbial protease activity using a protease site flanked by a fluorophore and quencher detection system. The emission wavelengths of the fluorophore are around 500nm (paragraphs [0038], [0073]).
The above references do not teach all the steps of claimed invention.
Gazendam (the whole document; page 1, lines 4-8; claims 20, 21; page 17, last two paragraphs) teaches that the invention is generally concerned with detection of infections in a bodily fluid to determine the presence of a pathogenic microorganism in the person from which the bodily sample was taken. Gazendam also discloses bacterial protease from different organisms as biomarkers (limitations of claims 30- 31) such as Staphylococcus, Streptococcus, E.coli, Bacillus ( see pages 7, 8, 9). Gazendam also discloses linkers, hydrocarbyl group and cyanine ( limitations of clams 28-29) see pages 6, 10-13 and 27. Gazendam also discloses limitations of claim 33, alanine, valine, leucine, isoleucine (see page 8). The general formulas X aa1,Xaa2 and Xaa3 sre inherent in the peptides and amino acids taught by Gazendam.
Additionally, Gazendam ( Gazendam claim 1) discloses. steps a, b and c of claim 26
Such a peptide comprising:
a) a first cleavage site, wherein said first cleavage site is cleaved by
a first compound specifically provided by a microbe belonging to a first group
consisting of a limited number of microbial strains, species or genera, and not cleaved
by any compound provided by any microbe not belonging to said first group,
b) a first fluorescent agent having an emission wavelength of 650-
900 nm,
c) a first non-fluorescent agent having an absorption wavelength of
650-900 nm, for quenching said emission of said first fluorescent agent,
wherein cleavage of said first cleavage site results in the release of said first quencher
agent from the coating, the release of said first agent being
indicative for the presence of a microbe belonging to said first group.( see page 2).
Gazendam also discloses limitations of claim 32, teaching 3-8 amino acids (see page
9).
Therefore, it would have been prima facie obvious at the time of applicants’ invention to combine the methods of references to obtain the instant invention.
It would have been obvious to one of ordinary skill in the art would be motivated by the teachings of Tolleshaug lyophilized compositions comprising a reagent and a carbohydrate and Sabsatian et al. teach beads. The benefit of the beads are that that the beads are with deterioration very stable and do not have any problems of the detectable signal over time, indicating that the beads are very durable ( Sabsatian et al. para 0102).
Additionally, Gazendam discloses. steps a, b and c of claim 26. The benefit of using the references together is that to make a lyophilized bead comprising an agent a carbohydrate to obtain an in vitro diagnosis method. The benefit of Gazendam is that it is using a peptide comprising a cleavage site.
As to limitations of claims 27 mass ratio and claim 34 %w of carbohydrate, these would be considered optimization of experimental parameters and would be obvious to one of ordinary skill in the art. However, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235(CCPA 1955).
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods to yield predictable results, thus the combination is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "The combination of familiar element according to known methods is likely to be obvious when it does no more than yield predictable results". It is well known to combine known methods which function in a predictable manner to yield a reasonable expectation of success along with predictable results to one of ordinary skill in the art at the time of the invention. Thus, it would have been obvious to a person of ordinary skill in the art to combine prior art elements according to known compositions that is ready for improvement to yield predictable results. The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing.
Conclusion
11. No claims are allowed.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHATOL S SHAHNAN SHAH whose telephone number is (571)272-0863. The examiner can normally be reached on Mon-Tues , Thurs-Fri 12pm-8pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel E. Kolker can be reached on 3181 The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Khatol S Shahnan-Shah/
Examiner, Art Unit 1645
February 9, 2026
/JANA A HINES/Primary Examiner, Art Unit 1645