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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/2/2026 has been entered.
Status of Claims
Cancelled: 143-162
Examined Herein: 163-173
Priority
Acknowledgment is made of applicant's claim for priority under based upon an application filed in PRO 63/070,057 on 8/25/2020 and PCT/US2021/047091 on 8/23/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/25/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings received on 2/22/2023 are accepted.
Withdrawn Rejections
All rejections of claims 143-162 are hereby withdrawn in view of their cancellation, which moots the rejections.
Claim Objections
Claim 168 is objected to because of the following informalities:
Claim 168 recites the limitation “a compound having formula (1),” which is inconsistent with how Formula (I) is written throughout the claim set. For clarity of the record, Applicant should consider amending the claim to recite “Formula (I).”
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.
Claims 163-173 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.
Claims 163 and 168 recite the limitation “L1-R1 is a… substituted cycloalkyl, or an unsubstituted cycloalkyl, wherein L1 is a bond or an unsubstituted C1-C4 alkylene, and R1 is hydrogen, a substituted or unsubstituted C1-C4 alkyl, phenyl, or substituted phenyl.” This limitation renders the scope of claims 163 and 168 indefinite, as the limitations recited within are internally inconsistent. None of the L1 and R1 substituents, when combined to form L1-R1, would yield a substituted or unsubstituted cycloalkyl. Accordingly, It is unclear whether L1-R1 can actually be a substituted or unsubstituted cycloalkyl and if so, how this formation can be achieved in view of the definitions of L1 and R1. Dependent claims fall therewith.
Claim 165 recites the limitation “wherein the compound has formula (II) and n3 is 1.” There is insufficient antecedent basis for this limitation in the claim. Formula (II) does not comprise an n3 substituent. Rather, only Formula (I) does.
Claim 168 recites the limitation “the leaving group Y.” There is insufficient antecedent basis for this limitation. Formula (I) and Formula (II) do not comprise a leaving group denoted by Y. Rather, Formula (I) and Formula (II) characterize the leaving group as R2. Dependent claims fall therewith.
Claims 170, 171, and 172 recite the limitation “the compound of claim 163.” There is insufficient antecedent basis for this limitation in the claim. The method of claim 168 does not incorporate the compound of claim 163. Accordingly, the scope of claims 168, 170, 171, and 172 cannot be ascertained because it is unclear whether or not the claim additionally requires the limitations of claim 163. Dependent claims fall therewith.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 170-172 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends.
Claims 170, 171, and 172 recite the limitation “The method of claim 168, wherein…the compound of claim 163.” However, the method of claim 168 does not incorporate the compound of claim 163. As a result, claims 170, 171, and 172 fail to limit the subject matter of claim 168. On the contrary, claims 170, 171, and 172 additionally incorporate the limitations of claim 163.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims complies with the statutory requirements.
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 163, 164, and 168-173 are rejected under 35 U.S.C. 103 as being unpatentable over Bain (US 2010/0173313 A1, Published 7/8/2010), in view of Yousefi (WO 2015/004029 A1, Published 1/15/2015).
With respect to claims 163 and 168, Bain discloses the compound TM30089. [Bain, 0021, 0024]
TM30089 has the following structure:
PNG
media_image1.png
500
758
media_image1.png
Greyscale
[Structure of TM-30089 retrieved from US 2017/0121773 A1, Paragraph 0050]
Wherein,
X1 and X2 are each CH
L1-R1 is an unsubstituted alkyl
L1 is a bond
R1 is an unsubstituted C1 alkyl
R2 is a leaving group (fluorine)
n1 is 1
n2 is 0
n3 is 2.
With respect to claim 164, Bain discloses that n3 is 2. [Bain, 0021, 0024]
With respect to claim 167, Bain discloses that L1-R1 is -CH3. [Bain, 0021, 0024]
With respect to claim 172, Bain discloses that the compound comprises an unprotected carboxylic acid. [Bain, 0021, 0024]
Furthermore, Bain discloses that TM-30089 is a DP2 antagonist/DP2 ligand. [Bain, 0021, 0024] The DP2 ligand may comprise a detectable label, including a radioactive label, 18F. [Bain, 0024-0026, 0249] Bain discloses that the incorporation of radioisotopes into the DP2 ligand is accomplished using known techniques, including isotopic labelling. [Bain, 0228, 0249] In a more specific embodiment, Bain discloses that 18F is a positron-emitting isotope that is detectable by a PET scanner and may be attached to the ligand. Moreover, Bain discloses that 18F (~110 min) has the longest half-life among all the other disclosed PET isotopes, including 11C (~20 min), 13N (~10 min), and 15O (~2 min). [Bain, 0251]
Bain does not disclose that R2 is -NO2 or +N(CH3)3 or a method of preparing the 18F-labeled compound.
However, with respect to claim 163, 168, 170, and 171, Yousefi discloses a method for the nucleophilic aromatic and heteroaromatic radiofluorination of molecules with aliphatic or aromatic carboxylic acid groups. Yousefi discloses that the method comprises providing a precursor compound comprising:
Providing an aromatic ring bearing a leaving group (nitro, bromo, chloro, fluoro, trialkylamino) for nucleophilic aromatic substitution reactions as a substituent and a saturated aliphatic group carrying at least one carboxylic acid group;
Reacting the precursor compound with a cation selected from a cationic chelate composed of a metal cation and a chelating agent and a quaternary ammonium cation, with an 18F anion in the presence of a phase transfer catalyst, such as a [2.2.2]-cryptand under conditions sufficient to replace the leaving group of the aromatic or heteroaromatic ring with a 18F substituent;
Yielding an aromatically radiofluorinated compound which comprises an aromatic ring bearing the 18F substituent at the position held by the leaving group in the precursor compound and a saturated aliphatic group carrying at least one carboxylic acid group (in the form of a free acid or in the form of a carboxylate salt). [Yousefi, Page 2, Paragraph 3-6; Page 11, Paragraph 5; Page 12, Paragraph 1]
In a specific embodiment, Yousefi discloses a method for radiolabeling a precursor compound comprising benzesulfonyl substituted with 4-fluoro or 4-nitro. The precursor compound is reacted with a [2.2.2]-cryptand under conditions that displace the leaving group with 18F, thereby providing the 18F-labeled compound at the position previously occupied by the leaving group. [Yousefi, Page 16, Scheme 1, Page 17, Scheme 2; Page 18, Scheme 3]
Moreover, Yousefi discloses that fluorine, chlorine, bromine, iodine, N(CH3)3+, and NO2 are leaving groups that an 18F-fluoride anion can replace in a nucleophilic aromatic substitution reaction. Yousefi further discloses that a -NO2 or -N(CH3)3+ leaving group is particularly preferred. [Yousefi, Page 6, Paragraph 2]
With respect to claim 169, Yousefi discloses that the fluorinating agent comprises K[18F]F and the [2.2.2]-cryptand is provided as [K([2.2.2]-cryptand)]2CO3. [Yousefi, Page 13, Paragraph 2; Page 14, Paragraph 3]
With respect to claim 172, Yousefi discloses that the reaction is carried out in a single step without protection of the carboxylic acid. [Yousefi, Page 2, Paragraph 3-6; Page 3, Paragraph 3; Page 16, Scheme 1, Page 17, Scheme 2; Page 18, Scheme 3]
With respect to claim 173, Yousefi discloses that the method further comprises treating the 18F-labeled compound with acid to provide its free-acid form. [Yousefi, Page 16, Paragraph 5]
Modifying the compound disclosed by Bain by replacing the R2 substituent (fluorine) with -NO2 results in the compound of claim 163 and 170, wherein the leaving group is -NO2.
Modifying the compound disclosed by Bain by replacing the R2 substituent (fluorine) with -N(CH3)3+ results in the compound of claim 163 and 171, wherein the leaving group is -N(CH3)3+.
Modifying the compound disclosed by Yousefi by replacing the R2 substituent (fluorine) with -NO2 and combining the modified compound with the method disclosed by Yousefi results in the method of claim 168, wherein the leaving group is -NO2.
Modifying the compound disclosed by Bain by replacing the R2 substituent (fluorine) with -NO2 or -N(CH3)3+ and combining the modified compound with the method disclosed by Yousefi results in the method of claim 168 and 172, wherein the leaving group is -NO2 or -N(CH3)3+ and the reaction is carried out in a single step without protecting the carboxylic acid.
It would be obvious to one of ordinary skill in the art to modify the compound disclosed by Bain by replacing the R2 substituent (fluorine) with -NO2 or -N(CH3)3+ and have a reasonable expectation of success. Bain discloses a DP2 ligand, TM30089, comprising an aromatic ring bearing a leaving group, fluorine. Bain further discloses that the compound may comprise a radioactive label, 18F, wherein the incorporation of the radioisotope into the DP2 ligand is accomplished using known techniques.
Yousefi discloses that fluorine, chlorine, bromine, iodine, N(CH3)3+, and NO2 are leaving groups which can be replaced by an 18F-fluoride anion in a nucleophilic aromatic substitution reaction, though a -NO2 or -N(CH3)3+ leaving group is particularly preferred. Accordingly, the combined teachings of Bain and Yousefi reasonably suggest that -NO2 or -N(CH3)3+ may function as the leaving group in the compound disclosed by Bain. One would have been motivated to do so because it is prima facie obvious to substitute equivalents known for the same purpose, when their equivalency is recognized in the prior art. MPEP 2144.06(II). In the present case, Yousefi discloses that fluorine, chlorine, bromine, iodine, N(CH3)3+, and NO2 are leaving groups which an 18F-fluoride anion can replace in a nucleophilic aromatic substitution reaction. Yousefi further discloses that the -NO2 or -N(CH3)3+ leaving group is particularly preferred. [Yousefi, Page 6, Paragraph 2] Therefore, substituting one leaving group (fluorine) for another, expressly preferred leaving group (-NO2 or -N(CH3)3+), is prima facie obvious.
It would be obvious to one of ordinary skill in the art to combine the modified compound disclosed by Bain with the method disclosed by Yousefi and have a reasonable expectation of success. Bain discloses a DP2 ligand, TM30089, comprising an aromatic ring bearing a leaving group and a saturated aliphatic group bearing a carboxylic acid group. Bain further discloses that the compound may comprise a radioactive label, 18F, wherein the incorporation of the radioisotope into the DP2 ligand is accomplished using known techniques. Yousefi discloses a method for radiofluorinating a compound via nucleophilic aromatic substitution wherein the compound comprises an aromatic ring bearing a leaving group and a saturated aliphatic group carrying at least one carboxylic acid group. Accordingly, the combined teachings of Bain and Yousefi reasonably suggest that the DP2 ligand disclosed by Bain may incorporate 18F using the method for radiofluorinating a compound via nucleophilic aromatic substitution, since the compound disclosed by Bain comprises an aromatic ring bearing a leaving group and a saturated aliphatic group carrying carboxylic acid. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. MPEP 2144(II). In the present case, Bain discloses that 18F is a positron-emitting isotope detectable by PET. [Bain, 0251] Yousefi discloses that the described method yields labeled molecules which can be used as radiotracers. [Yousefi, Abstract] Therefore, one would have been motivated by the expectation that combining the modified compound disclosed by Bain with the method disclosed by Yousefi would yield a compound that can be used as a radiotracer in PET imaging.
Claims 163, 165, 166, and 168-172 are rejected under 35 U.S.C. 103 as being unpatentable over Hutchinson (US 2011/0152338 A1, Published 6/23/2011), in view of Bain and Cai (Chemistry with [18F]Fluoride Ion, Eur. J. Org. Chem. 2008, 2853–2873).
With respect to claim 163, Hutchinson discloses the following compound:
PNG
media_image2.png
480
1005
media_image2.png
Greyscale
[Structure drawn by examiner using CAS Draw based on Compound 1-1 as an embodiment of Formula II disclosed by Hutchinson, 0147]
Wherein,
X1 and X2 are each CH
L1-R1 is a substituted alkyl
L1 is a bond
R1 is a substituted C2 alkyl
R2 is a leaving group (fluorine)
n1 is 1
n2 is 0
n3 is 1. [Hutchinson, 0147, Compound 1-1]
With respect to claim 165, Hutchinson discloses that n3 is 1. [Hutchinson, 0147, Compound 1-1]
With respect to claim 172, Hutchinson discloses that the compound comprises an unprotected carboxylic acid. [Hutchinson, 0147, Compound 1-1]
Moreover, Hutchinson discloses that fluorine is the substituent on the substituted phenyl ring (R2). [Hutchinson, 0143, 0147, 0200, 0357, 0349] Hutchinson additionally discloses that the phenyl may be substituted with a -F, -NO2, -Br, -Cl, or -I substituent. [Hutchinson, 0200]
Hutchinson does not disclose that R2 is -NO2 or +N(CH3)3 or a method of radiofluorinating the compound with 18F.
However, with respect to claims 163 and 168, Bain discloses that TM-30089 is a DP2 antagonist/DP2 ligand. [Bain, 0021, 0024] The DP2 ligand may comprise a detectable label, including a radioactive label, 18F. [Bain, 0024-0026, 0249] Bain discloses that the incorporation of radioisotopes into the DP2 ligand is accomplished using known techniques, including isotopic labelling. [Bain, 0228, 0249] In a more specific embodiment, Bain discloses that 18F is a positron-emitting isotope that is detectable by a PET scanner and may be attached to the ligand. Moreover, Bain discloses that 18F (~110 min) has the longest half-life among all the other disclosed PET isotopes including 11C (~20 min), 13N (~10 min), and 15O (~2 min). [Bain, 0251]
Furthermore, with respect to claims 163, 166, 168, 170, and 171, Cai discloses a method for synthesizing aryl-18F compounds via nucleophilic substitution comprising:
Providing a compound comprising an aryl ring comprising a leaving group (i.e., iodine, bromine, chlorine, fluorine, NO2, +NMe3) at the para position;
Reacting the compound in the presence of a [2.2.2]-cryptand under conditions that displace the leaving group with -18F;
Yielding a radiofluorinated compound wherein the aryl ring bears the 18F substituent at the position held by the leaving group. [Page 2856, Col. 1 (entire) – Col. 2, Paragraph 1-2; Page 2857, Col. 2, Paragraph 4; Page 2588 (entire), Page 2589, Col. 1 (entire) & Scheme 15]]
Moreover, Cai discloses that fluorine, chlorine, bromine, iodine, N(CH3)3 +, and NO2 are suitable leaving groups for the aforementioned reaction. Cai identifies +NMe3 as a good leaving group, with chloride, perchlorate, or triflate as the counterion, which advantageously permits easy separation of the labeled product from the precursor (because of the charge difference).
With respect to claim 169, Cai discloses that the fluorinating agent may comprise K[18F]F and the [2.2.2]-cryptand may be provided as K([2.2.2.]-cryptand)2CO3. [Page 2856, Col. 2, Paragraph 2; Page 2857, Col. 2, Paragraph 4; See also Scheme 10-15]
With respect to claim 172, Cai discloses that the reaction is carried out in a single step and without the protection of the carboxylic acid. [Page 2856, Col. 1 (entire) – Col. 2, Paragraph 1-2; Page 2857, Col. 2, Paragraph 4; Page 2588 (entire), Page 2589, Col. 1 (entire) & Scheme 15]]
Modifying the compound disclosed by Hutchinson by replacing the R2 substituent (fluorine) with -NO2 results in the compound of claim 163 and 170, wherein the leaving group is -NO2.
Modifying the compound disclosed by Hutchinson by replacing the R2 substituent (fluorine) with -N(CH3)3+ results in the compound of claim 163 and 171, wherein the leaving group is -N(CH3)3+.
Modifying the compound disclosed by Hutchinson by replacing the R2 substituent (fluorine) with -N(CH3)3+ (further comprising a triflate counterion) results in the compound of claim 163, 166, and 171, wherein the leaving group is -N(CH3)3+.
Modifying the compound disclosed by Hutchinson by replacing the R2 substituent (fluorine) with -NO2 or -N(CH3)3+ and combining the modified compound with the method disclosed by Yousefi results in the method of claim 168 and 172, wherein the leaving group is -NO2 or -N(CH3)3+ and the reaction is carried out in a single step without protecting the carboxylic acid.
It would be obvious to one of ordinary skill in the art to modify the compound disclosed by Hutchinson by replacing the R2 substituent (fluorine) with -NO2 or -N(CH3)3+ and have a reasonable expectation of success. Hutchinson discloses a DP2 ligand comprising an aromatic ring bearing a leaving group, fluorine. Hutchinson additionally discloses that the aromatic ring may alternatively be substituted with -NO2. Bain discloses several DP2 ligands which may be radiolabeled with 18F. Bain further discloses that the incorporation of 18F into the DP2 ligands is accomplished using known techniques. Cai discloses that fluorine, chlorine, bromine, iodine, N(CH3)3+ (including with a triflate counterion), and NO2 are suitable leaving groups for use in a nucleophilic aromatic substitution reaction for synthesizing aryl-18F compounds. Accordingly, the combined teachings of Hutchinson, Bain, and Cai suggest that the DP2 ligand disclosed by Hutchinson is amenable to radiofluorination with 18F and that -NO2 or -N(CH3)3+ may function as the leaving group in the compound disclosed by Hutchinson. One would have been motivated to do so because it is prima facie obvious to substitute equivalents known for the same purpose, when their equivalency is recognized in the prior art. MPEP 2144.06(II). In the present case, Cai discloses that N(CH3)3+ (including with a triflate counterion) and NO2 are suitable leaving groups for use in a nucleophilic aromatic substitution reaction for synthesizing aryl-18F compounds. Therefore, substituting one leaving group (fluorine) for another leaving group (-NO2 or -N(CH3)3+), is prima facie obvious.
It would be obvious to one of ordinary skill in the art to combine the modified compound disclosed by Hutchinson with the method disclosed by Yousefi and have a reasonable expectation of success. Hutchinson discloses a DP2 ligand comprising an aromatic ring bearing a leaving group, fluorine. Bain discloses several DP2 ligands which may be radiolabeled with 18F. Bain further discloses that the incorporation of 18F into the DP2 ligands is accomplished using known techniques. Cai discloses a method for radiofluorinating a compound via aromatic nucleophilic substitution wherein the compound comprises an aromatic ring bearing a leaving group (-F, -NO2 or -N(CH3)3+). Accordingly, the combined teachings of Hutchninson, Bain, and Cai reasonably suggest that the DP2 ligand disclosed by Hutchin may incorporate 18F using the method for radiofluorinating a compound via nucleophilic aromatic substitution, since the compound disclosed by Hutchinson comprises an aromatic ring bearing a leaving group and, amenable as a DP2 ligand, is to radiofluorination with 18F. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. MPEP 2144(II). In the present case, Bain discloses that 18F is a positron-emitting isotope detectable by PET. [Bain, 0251] Cai discloses that the described method yields 18F-labeled radiotracers. [Cai, Cite] Therefore, one would have been motivated by the expectation that combining the modified compound disclosed by Hutchinson with the method disclosed by Cai would yield a radiotracer useful in PET imaging.
Response to Arguments
Applicant's arguments filed 9/2/2026 have been fully considered but they are not persuasive.
Applicant asserts, “The newly claimed precursor compound is structurally distinct from a carbazole, and it is entirely structurally disparate from the diphenyl ether scaffolds exclusively synthesized in Bain' s working Examples. Because Bain is directed strictly to the preparation and utility of diphenyl ether scaffolds, it provides absolutely no motivation, structural guidance, or reasonable expectation of success to synthesize the claimed precursor structure.” [Remarks 9/2/2026, Page 8]
Applicant’s arguments are not persuasive because the rejection of record does not rely on the diphenyl ether scaffolds synthesized in Bain’s working examples. Rather, the rejection of record relies on TM30089, a specifically identified DP2 antagonist disclosed by Bain. Accordingly, the structural distinction between the diphenyl ether scaffolds and TM30089 is not germane to the instant rejection, as the former does not form the basis of the rejection.
Moreover, Bain discloses “The examples and embodiments described herein are for illustrative purposes only and various modifications or changes suggested to persons skilled in the art are to be included within the spirit and purview of this application and scope of the appended claims. The section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described.” [Bain, 0301] Accordingly, a POSITA would not limit Bain’s disclosure to only the working examples cited because Bain explicitly cautions against doing so.
To the extent that Applicant believes that the motivation to modify Bain must come from Bain or that a POSITA may only glean the motivation to based on teachings drawn to a structurally similar compound, this contention is mistaken. The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. MPEP 2144(I).
Applicant asserts, “Under wellsettled precedent, it is impermissible hindsight to reject a precursor simply because it could theoretically be used down the line to form a product class mentioned in the art (See In re Ochiai, 71 F.3d 1565 (Fed. Cir. 1995); MPEP § 2144.09(VI)). A person of ordinary skill in the art would look at Bain and be motivated to adopt di phenyl ethers, not the structurally unrelated precursor claimed here.”
The rejection of record does not state that a POSITA would be motivated to adopt diphenyl ethers based Bain’s disclosure. The rejection of record does not rely on Bain’s disclosure of diphenyl ethers at all. Accordingly, Applicant’s assertion that the Office relied on impermissible hindsight to arrive at this conclusion is unfounded.
With respect to Applicant’s remarks regarding Hutchinson [Remarks 9/2/2026, Page 8-9]:
Applicant’s arguments are not persuasive because the rejection of record over Hutchinson additionally relies on Bain and Cai. Cai expressly teaches nitro as a known leaving group for F18 nucleophilic aromatic displacement and further discloses that F18-labeled compounds are useful for PET imaging, thereby providing the specific structural guidance and reasonable expectation of success required by the applicable standard.
Moreover, the absence of a para-nitro working example in Hutchinson does not preclude a finding of obviousness because working examples are not required to establish a prima facie case of obviousness. Cai provides an art-recognized functional reason to select nitro at that position, and Hutchinson explicitly makes clear that substituting nitro at that position is within the scope of the disclosure.
Applicant asserts, “Duggan nor Berger do not remedy the deficiencies of Bain or because the reference does not provide an enabling disclosure or a reasonable expectation of success for the claimed structures.” [Remarks 9/2/2026, Page 10-11]
While the rejection of record no longer relies on Duggan or Berger, Applicant is reminded that
the prior art is presumed to be operable and enabling. When the reference relied upon makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on Applicant to rebut the presumption of operability. MPEP 2112.01. Applicant has not provided any support for the assertion that the disclosure of Duggan or Berger is not enabling, and a mere allegation that the disclosure of Duggan or Berger is not enabling cannot take the place of evidence in the record. MPEP 2145(I).
Applicant’s arguments with respect to Tanimoto have been considered but are moot because the new ground of rejection does not rely on Tanimoto for any teaching or matter specifically challenged in the argument. [Remarks 9/2/2026, Page 9-10]
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAILA A CRAIG whose telephone number is (703)756-4540. The examiner can normally be reached Monday-Friday 0800-1600.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/K.A.C./Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
Prosecution Insights