DETAILED ACTION
Claim Objections
Claim 5 is objected to because of the following informalities: In line 1, please insert “alternate” prior to “counterion”.
Claim 5 is objected to because of the following informalities: In line 2, the species o-benzenedisulfonimide is a discrete, charge neutral compound rather than a counterion.
Claim 10 is objected to because of the following informalities: Claim is drawn to a molecule comprising an amino aryloxyl monomer. A molecule is a discrete entity and therefore cannot “comprise” other than the molecule itself. Please replace “comprise” with “that is” or rewrite the claim as “An amino aryloxyl monomer comprising a polymerizable double bond …” 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.
Claim 6 is rejected under 35 U.S.C. 112(b)as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claim is drawn to a composition containing a diazonium salt represented by Formula (I) in which R1 is ether or alcohol. The description of these embodiments is incorrect. Claim appears to state that substituent OR1 is ether, such that R1 is alkyl group, or substituent OR1 is alcohol, such that R1 is hydrogen.
Claim 8 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claim is drawn to a composition containing a diazonium salt represented by Formula (IA) in which R3 is ether. The description of such embodiment is incorrect. Claim appears to state that substituent OR3 is ether, such that R3 is an alkyl group.
Claim 10 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claim is drawn to an amino aryloxyl monomer comprising a polymerizable double bond (see also paragraph 3, supra) in which substituent R4 is alkyl. A compound in which R4 is alkyl and n is 1 lacks the requisite polymerizable double bond and does not satisfy the structural parameters set forth in Formula (II). The specification was consulted for guidance. Exemplary compounds, depicted on page 2 and represented by Formula (IID) and Formula (IIE), reproduced below, contain polymerizable double bonds as 3-butenyloxy groups. Claim defines substituent R4 as vinyl (-CH=CH2) but excludes embodiments in which R4 is 3-butenyl (-CH2CH2CH=CH2). Therefore, these exemplary compounds fail to satisfy the structural features set forth in Formula (II).
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Claim also defines R4 as acrylate or methacrylate. The description of these embodiments is incorrect. Claim appears to state that substituent OR4 is acryloyloxy (acrylate), such that R4 is an acryloyl group, or substituent OR4 is methacryloyloxy (methacrylate), such that R4 is a methacryloyl group.
Based on these considerations, claim is deemed indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention
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.
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 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Potts et al. (US 4,902,601).
Example 1 of Potts et al. teaches preparation of an acrylic polymer wherein a diazonium salt group is covalently bonded to polymerized monomers. A sample of isocyanatoethyl methacrylate (IEM) is polymerized to form a poly(IEM) homopolymer using a radical initiator, followed by reaction of poly(IEM) with p-(N-ethyl-N-hydroxyethyl)aminoacetanilide precursor. The diazonium group is introduced by further treating with aqueous sodium nitrite. The counterion appears to be sodium cation, but quenching of the reaction in the final step with sulfamic acid would introduce sulfamate counteranion into the polymer. Example 4 shows a similar procedure except IEM is copolymerized with methyl methacrylate and lauryl methacrylate to form a terpolymer.
Claims 1 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burkle et al. (US 4,299,907).
Burkle et al. discloses a diazo polymer having a general formula shown to the right in which Z is an anion of a sulfonic, carboxylic (carboxylate anion), or phosphoric acid. Such polymer has a diazonium salt group covalently bonded to polymerized monomers.
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Claims 1 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Minamizono et al. (US 4,581,313).
Minamizono et al. discloses a diazo polymer having a general formula shown to the right in which Z is an anion of a toulenesulfonic acid (tosylate anion; col. 2, line 57). Such polymer has a diazonium salt group covalently bonded to polymerized monomers
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Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lecco et al. (US 3,616,351).
Example 12 of Lecco et al. discloses a test strip prepared from a mixture of a diazonium salt of 5-nitro-2-aminotoluene and cellulose acetate. In this case, a diazonium salt is non-covalently dispersed throughout polymerized monomers.
Claims 1 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lischewski et al. (US 6,015,621).
Lischewski et al. discloses composition comprising 2,4-dimethoxybenzene diazonium tetrafluoroborate (corresponding to Formula (I) wherein A is absent, R1 is alkyl, n is 2, R2 is H) and cellulose acetate. In this case, a diazonium salt is non-covalently dispersed throughout polymerized monomers.
Claims 1, 6, and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Adams et al. (US 2,378,276).
Adams et al. discloses composition comprising a diazonium salt derived from 2-nitro-4-methoxyaniline (3-nitro-4-aminoanisole; corresponding to Formula (I) wherein A is NO2, R1 is alkyl, n is 1, R2 is H) and starch paste (col. 2, line 17). In this case, a diazonium salt is non-covalently dispersed throughout polymerized monomers.
Claims 1, 18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Katusyama et al. (US 4,902,477).
Example 2 of Katusyama et al. discloses a test strip prepared from a mixture of 5-methoxy-5-(tetradecyloxycarbonyl)benzene diazonium tetrafluoroborate and methyl vinyl ether-maleic anhydride copolymer. In this case, a diazonium salt is non-covalently dispersed throughout polymerized monomers. The test strip comprises the diazonium salt-polymer mixture, a cellulose acetate membrane filter (mean pore size 0.3 µm) and a paper filter layer. The cellulose acetate membrane is substantially transparent and both substrates are porous. The test strip is used for detection of bilirubin in serum.
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Katusyama et al. (US 4,902,477) in view of Ruiz et al. (Adv. Lab Med. 2021, 2(3), 352-361).
Ruiz et al. teaches that the best method to detect serum bilirubin is by diazo transfer reaction. However, presence of bilirubin may also be determined by testing urine and feces (page 355). One of ordinary skill in the art would have found it obvious to use the test strip of Katsuyama et al. to test presence of bilirubin in blood since blood contains serum. The skilled artisan also would have found it obvious to use the test strip to test urine. Reference teaches that the reaction
of bilirubin with a diazo reagent, such as that of Katsuyama et al., can be measured at neutral pH or under alkaline pH. One of ordinary skill in the art would have found it obvious to incorporate a buffer to maintain test conditions at pH 7 or higher.
Claim 10 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by SU 426993.
Prior art discloses the compound 4-vinyloxyaniline, corresponding to the compound of Formula (II) in which A is absent, R4 is vinyl, n is 1, and R2 is hydrogen. See paragraphs [0013] and [0042].
Claim 10 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aya et al. (US 3,787,393).
Aya et al. discloses the compound 2,4-dichloro-5-vinyloxyaniline (col. 3, line 27), corresponding to the compound of Formula (II) in which A is absent, R4 is vinyl, n is 1, R2 is halogen, and m is 2.
Claim 10 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moszner et al. (US 6,136,887).
Moszner et al. discloses the compounds 4-aminophenyl (meth)acrylate (col. 9, line 22), corresponding to the compound of Formula (II) in which A is absent, R4 is (meth)acryloyl, n is 1, and R2 is hydrogen.
Allowable Subject Matter
Claims 8, 9, and 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten to overcome the rejection under 35 U.S.C. 112(b) (claim 8, see paragraph 6, supra) in independent form including all of the limitations of the base claim and any intervening claims. None of the cited references teaches claimed compositions containing the compound of Formula (IA) or the compound of Formula (IB). Cited references do not teach the test strip of claim 19 in which a diazonium salt is covalently attached to polymerized monomers.
Claims 25-27, 31, and 32 are allowed. None of cited references teaches the method of making a composition using the steps set forth in claims.
Specification
The disclosure is objected to because of the following informalities:
On page 16, line 3, specification recites “substrate 103” and “substrate material 103”. Select one of the terms and ensure it is used consistently throughout the written description.
On page 16, line 5, please replace “and seal 104” with “and removable seal 104”.
On page 16, line 9, the term “sensing chemicals, 105a” is inconsistent with the term “test spots 105a” written in line 3.
On page 16, line 11, the term “sample fluid 200” is inconsistent with the term “sample 200” written in lines 9 and 10.
On page 16, line 13, the term “shaded sensing chemicals 208” is inconsistent with the term “sensing chemicals 208” written in line 12. Use of the term “shaded sensing chemicals 208a” is suggested to differentiate the two related terms.
On page 16, line 13, please replace “chemical reacts” with “sensing chemical 208 reacts”.
On page 16, line 15, the term “test fluid 200” is inconsistent with the term “sample 200” written in lines 9 and 10.
Appropriate corrections are required.
Drawings
Figure 9 is objected to because of the following informalities:
a) In the cropped figure shown below, replace “204” with “200”.
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b) In the cropped figure shown below, reference numeral 208, corresponding to “sensing chemicals” should only point to rectangles that are not shaded. See also objections to specification, paragraph 28, supra.
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Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rip A. Lee whose telephone number is (571)272-1104. The examiner can be reached on Monday through Friday from 9:00 AM - 5:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Jones, can be reached at (571)270-7733. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/RIP A LEE/
Primary Examiner, Art Unit 1762
January 22, 2026