DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of species (10) (the biological sample comprises a tissue sample or a cytology sample (see claim 57) in the reply filed on July 14, 2025 is acknowledged. Applicant’s election of “an NHS ester” in claim 61 in the reply filed on October 21, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement related to claim 61, the election has been treated as an election without traverse (MPEP § 818.01(a)). The objections and rejections not reiterated from the previous office action are hereby withdrawn in view of applicant’s amendment filed on September 24, 2024. Claims 30, 32, 34, 36, 38, 40, 42, 44, 46, 47, and 54-70 will be examined.
Claim Rejections - 35 USC § 112
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.
Scope of Enablement
This rejection is different from the rejection under 35 U.S.C. 112(a) mailed on July 17, 2024.
Claims 30, 32, 34, 36, 38, 40, 42, 44, 46, 47, and 54-70 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for performing the methods recited in claims 30, 32, 34, 36, 38, 40, 42, 44, 46, 47, and 54-70 when the chromogenic moiety is a visible chromogen, does not reasonably provide enablement for performing the methods recited in claims 30, 32, 34, 36, 38, 40, 42, 44, 46, 47, and 54-70 by detecting the target antigen in the stained tissue sample and the stained biological sample by detecting a signal produced by the chromogenic moiety of the signaling complex using a bright-field microscopy method when the signal is a spectral absorbance of an incident light generated by the chromogenic moiety and the chromogenic moiety is an invisible chromogen. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (CA FC 1988). Wands states at page 1404,
“Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.”
The Nature of The Invention
The claims are drawn to a tissue staining method and a biological sample staining method. The invention is a class of invention which the CAFC has characterized as “the unpredictable arts such as chemistry and biology.” Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
The Breadth of The Claims
Claims 30, 32, 34, 36, 38, 40, 42, 44, 46, 63, 65, and 67 encompass a tissue staining method, comprising: (a) contacting a tissue sample comprising a tissue on a solid support that possibly contains a target antigen comprising a polypeptide or a nucleic acid, with a detection probe comprising a primary antibody specific for the target antigen, whereby the primary antibody binds to the target antigen if the target antigen is present in the tissue sample, and then washing the tissue sample to remove the detection probe that is not bound to the target antigen, thereby producing an antibody-target complex comprising the primary antibody bound to the target antigen; (b) after step (a), contacting the tissue sample with a labeling conjugate comprising a secondary antibody covalently linked to an enzyme, wherein the secondary antibody 1s specific for the primary antibody, and the enzyme is a peroxidase, whereby, if the target antigen is present in the tissue sample, the secondary antibody binds to the primary antibody of the antibody-target complex, and then washing the tissue sample to remove the labeling conjugate that is not bound to the primary antibody of the antibody-target complex, thereby producing a labeled complex comprising the labeling conjugate bound to the primary antibody of the antibody-target complex; (c) after step (b), contacting the tissue sample with a signaling conjugate comprising a phenolic moiety linked to a chromogenic moiety, whereby, if the target antigen is present in the tissue sample, the enzyme of the labeled complex catalyzes conversion of the phenolic moiety into a reactive species comprising the chromogenic moiety which then covalently binds to: (i) a location on the tissue sample near the labeled complex; and/or (ii) a location on the labeled complex; thereby producing a stained tissue sample comprising a deposited chromogen comprising the chromogenic moiety covalently bound to the location (1) and/or the location (ii), and then washing the stained tissue sample to remove the signaling conjugate that 1s not covalently bound to the stained tissue sample or the labeled complex; (d) after step (c), analyzing the stained tissue sample by a bright-field microcopy method comprising: (i) exposing the stained tissue sample to an incident light such that, if the target antigen is present in the tissue sample, the deposited chromogen generates a spectral absorbance of the incident light and a transmitted light passes through the stained biological sample, thereby producing a signal that provides for the detection of the target antigen, and (ii) detecting the signal using visual identification, a digital camera, and/or a spectral imaging camera, wherein the transmitted light is detected. Claims 47, 54-62, 64, 66, and 68-70 encompass
staining method comprising: (a) contacting a biological sample on a solid support that potentially comprises a target antigen comprising a polypeptide or a nucleic acid with a detection probe comprising a primary antibody that is specific for and binds to the target antigen, thereby producing an antibody-target complex; (b) after step (a), contacting the biological sample with a labeling conjugate comprising a peroxidase covalently linked to a secondary antibody that is specific for and binds to the primary antibody of the antibody-target complex, thereby producing a labeled complex comprising; (c) after step (b), contacting the biological sample with a signaling conjugate comprising a phenolic moiety linked to a chromogenic moiety, wherein the peroxidase of the labeled complex catalyzes conversion of the phenolic moiety into a reactive species, which covalently binds to: (i) a location on the biological sample near the labeled complex; and/or (i1) a location on the labeled complex; thereby producing a stained sample comprising a deposited chromogen; (d) after step (c), analyzing the stained sample by a bright-field microcopy method comprising: (i) exposing the stained tissue sample to an incident light such that, if the target antigen is present in the biological sample, the deposited chromogen generates a spectral absorbance of the incident light and a transmitted light passes through the stained biological sample, thereby producing a signal that provides for the detection of the target antigen; and (ii) detecting the signal using visual identification, a digital camera, and/or a spectral imaging camera, wherein the transmitted light is detected.
Working Examples
The specification provides 10 examples (see pages 36-41 of US 2020/0326345 A1, which is US publication of this instant case). However, the specification provides no working example for performing the methods recited in claims 30, 32, 34, 36, 38, 40, 42, 44, 46, 47, and 54-70 by detecting the target antigen in the stained tissue sample and the stained biological sample by detecting a signal produced by the chromogenic moiety of the signaling complex using a bright-field microscopy method when the signal is a spectral absorbance of an incident light generated by the chromogenic moiety and the chromogenic moiety is an invisible chromogen.
The Amount of Direction or Guidance Provided and The State of The Prior Art
Although the specification provides 10 examples (see pages 36-41 of US 2020/0326345 A1, which is US publication of this instant case), the specification provides no working example for performing the methods recited in claims 30, 32, 34, 36, 38, 40, 42, 44, 46, 47, and 54-70 by detecting the target antigen in the stained tissue sample and the stained biological sample by detecting a signal produced by the chromogenic moiety of the signaling complex using a bright-field microscopy method when the signal is a spectral absorbance of an incident light generated by the chromogenic moiety and the chromogenic moiety is an invisible chromogen. Furthermore, there is no experimental condition and/or experimental data in the specification to support the claimed invention. During the process of the prior art search, the examiner has not found any prior art which is related to perform the methods recited in claims 30, 32, 34, 36, 38, 40, 42, 44, 46, 47, and 54-70 by detecting the target antigen in the stained tissue sample and the stained biological sample by detecting a signal produced by the chromogenic moiety of the signaling complex using a bright-field microscopy method when the signal is a spectral absorbance of an incident light generated by the chromogenic moiety and the chromogenic moiety is an invisible chromogen.
Level of Skill in The Art, The Unpredictability of The Art, and The Quantity of Experimentation Necessary
While the relative skill in the art is very high (the Ph.D. degree with laboratory experience), there is no predictability whether the methods recited in claims 30, 32, 34, 36, 38, 40, 42, 44, 46, 47, and 54-70 can be performed by detecting the target antigen in the stained tissue sample and the stained biological sample by detecting a signal produced by the chromogenic moiety of the signaling complex using a bright-field microscopy method when the signal is a spectral absorbance of an incident light generated by the chromogenic moiety and the chromogenic moiety is an invisible chromogen.
Since the specification shows that “[F]IGS. 17(A-D) are photomicrographs of tissues stained with signaling conjugates having different chromogenic moieties. FIG. 17(E) shows UV-Vis spectra with traces corresponding to the absorbance of the signaling conjugates, the traces corresponding to the associated photomicrograph. As such, trace (A) of FIG. 17(E) corresponds to the signaling conjugate shown in FIG. 17(A). The other traces are similarly associated with the corresponding photomicrographs. The blue color apparent in the slide is a commercially available bluing solution. FIG. 17(A) and trace ‘A’ of FIG. 17(E) shows a malachite green signaling conjugate. It is classifiable as a I(b) signaling conjugate according to Table 1. FIG. 17(B) and trace ‘B’ of FIG. 17(E) shows a tartrazine signaling conjugate. It is classifiable as a I(c) signaling conjugate according to Table 1. FIG. 17(C) and trace ‘C’ of FIG. 17(E) shows a sulforhodamine B signaling conjugate. It is classifiable as a IV(b) signaling conjugate according to Table 1. FIG. 17(D) and trace ‘D’ of FIG. 17(E) shows a Victoria Blue signaling conjugate. It is classifiable as a VI(c) signaling conjugate according to Table 1”, “[F]IG. 18(A-D) are photomicrographs of tissues stained with signaling conjugates having different chromogenic moieties. FIG. 18(E) shows UV-Vis spectra with traces corresponding to the absorbance of the signaling conjugates, the traces corresponding to the associated photomicrograph. FIG. 18(A) and trace ‘A’ of FIG. 18(E) shows a coumarin (4-(diethylamino)-2-oxo-2H-chromene-3-carboxylic acid) signaling conjugate. It is classifiable as a I(b) signaling conjugate according to Table 1. FIG. 18(B) and trace ‘B’ of FIG. 18(E) show a Dabsyl (dimethylaminoazobenzene- sulfonic acid) signaling conjugate. It is classifiable as a II(b) signaling conjugate according to Table 1. FIG. 18(C) and trace ‘C’ of FIG. 18(E) shows a TAMRA signaling conjugate. It is classifiable as a III(b) signaling conjugate according to Table 1. FIG. 18(D) and trace ‘D’ of FIG. 18(E) shows a 5-(and-6)-carboxyrhodamine 110 signaling conjugate. It is classifiable as a V(a) signaling conjugate according to Table 1”, “[F]IGS. 19(AD) are photomicrographs of tissues stained with signaling conjugates having different chromogenic moieties. FIG. 19(E) shows UV-Vis spectra with traces corresponding to the absorbance of the signaling conjugates, the traces corresponding to the associated photomicrograph. FIG. 19(A) and trace ‘A’ of FIG. 19(E) shows a FITC (1-(3’,6’-dihydroxy-3-oxospiro(isobenzofuran-1(3H),9’-(9H)xanthen-5-yl) signaling conjugate. It is classifiable as a III(b) signaling conjugate according to Table 1. FIG. 19(B) and trace ‘B’ of FIG. 19(E) shows a Rhodamine 6G signaling conjugate. It is classifiable as a III(c) signaling conjugate according to Table 1. FIG. 19(C) and trace ‘C’ of FIG. 19(E) shows a Texas Red (sulforhodamine 101) signaling conjugate. It is classifiable as a IV(c) signaling conjugate according to Table 1. FIG. 19(D) and trace ‘D’ of FIG. 19(E) shows a cy5 signaling conjugate. It is classifiable as a VI(c) signaling conjugate according to Table 1”, and “[F]IG. 20(AD) are photomicrographs of tissues stained with signaling conjugates having different chromogenic moieties. FIG. 20(E) shows UV-Vis spectra with traces corresponding to the absorbance of the signaling conjugates, the traces corresponding to the associated photomicrograph. FIG. 20(A)
and trace ‘A’ of FIG. 20(E) shows a Rhodamine 110 signaling conjugate. It is classifiable as a III(b) signaling conjugate according to Table 1. FIG. 20(B) and trace ‘B’ of FIG. 20(E) shows a JOE (6-Carboxy-4’,5’-dichloro-2’,7’-dimethoxyfluorescein, succinimidyl ester) signaling conjugate. It is classifiable as a III(c) signaling conjugate according to Table 1. FIG. 20(C) and trace ‘C’ of FIG. 20(E) shows a gallocyanine signaling conjugate. It is classifiable as a III(c) signaling conjugate according to Table 1. FIG. 19(D) and trace ‘D’ of FIG. 19(E) shows a carboxyrhodamine B signaling conjugate. It is also classifiable as a III(c) signaling conjugate according to Table 1” (see paragraphs [0183] to [0186] and Figures 17 to 20 of US 2020/0326345 A1, which is US publication of this instant application), the specification clearly indicates that UV-Vis spectra with traces in Figures 17 to 20 correspond to the absorbances of different visible chromogens. Since it is known that “[B]right-field microscopy is the simplest of all the optical microscopy illumination techniques. Sample illumination is transmitted white light, and contrast in the sample is caused by attenuation of the transmitted light in dense areas of the sample” and “[S]amples that are naturally colorless and transparent cannot be seen well” (see pages 1 and 2 of “Bright field microscopy” from Wikipedia), applicant’s paper defines “invisible chromogens” as “dyes deposited by enzymatic action, like conventional chromogens, but having absorbance in the ultraviolet (UV) or near infrared (NIR) predominantly outside the boundaries of human visual response” (see page 546, left column, last paragraph from Morrison et al., Laboratory Investigation, 102, 545-553, 2022), near infrared dyes show light absorption in the near infrared area of 700-2000 nm (see “Near-Infrared (NIR) Dyes”), and the specification and available arts do not show that the absorbance of an invisible chromogen can be detected using bright-field microscopy method when the invisible chromogen of a signaling complex of a stained tissue sample or a stained biological sample on the solid support is exposed to an incident light, if the chromogenic moiety as recited in claims 30, 32, 34, 36, 38, 40, 42, 44, 46, 47, and 54-70 is an invisible chromogen which is a near infrared dye having a light absorption in the near infrared area of 700-2000 nm such as EC7 dye (see Wei et al., abstract from J. AM. Chem. Soc., 145, 12013-12022, 2023), an image of the invisible chromogen cannot be generated by a bright-field microscope such that an absorbance image of the invisible chromogen cannot be produced by converting a bright-field microscope image to an absorbance image and it is unpredictable how the target antigen in the stained tissue sample and the stained biological sample can be detected by detecting a signal produced by the chromogenic moiety of the signaling complex using a bright-field microscopy method when the signal is a spectral absorbance of an incident light generated by the chromogenic moiety and the chromogenic moiety is an invisible chromogen as recited in claims 30, 32, 34, 36, 38, 40, 42, 44, 46, 47, and 54-70.
Case law has established that “(t)o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’.” In re Wright 990 F.2d 1557, 1561. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) it was determined that “[T]he scope of the claims must bear a reasonable correlation to the scope of enablement provided by the specification to persons of ordinary skill in the art”. The amount of guidance needed to enable the invention is related to the amount of knowledge in the art as well as the predictability in the art. Furthermore, the Court in Genentech Inc. v Novo Nordisk 42 USPQ2d 1001 held that “[I]t is the specification, not the knowledge of one skilled in the art that must supply the novel aspects of the invention in order to constitute adequate enablement”.
In view of above discussions, the skilled artisan will have no way to predict the experimental results. Accordingly, it is concluded that undue experimentation is required to make the invention as it is claimed. These undue experimentation at least includes to test whether the methods recited in claims 30, 32, 34, 36, 38, 40, 42, 44, 46, 47, and 54-70 can be performed by detecting the target antigen in the stained tissue sample and the stained biological sample by detecting a signal produced by the chromogenic moiety of the signaling complex using a bright-field microscopy method when the signal is a spectral absorbance of an incident light generated by the chromogenic moiety and the chromogenic moiety is an invisible chromogen.
Conclusion
In the instant case, as discussed above, the level of unpredictability in the art is high, the specification provides one with no guidance that leads one to claimed methods. One of skill in the art cannot readily anticipate the effect of a change within the subject matter to which the claimed invention pertains. Thus given the broad claims in an art whose nature is identified as unpredictable, the unpredictability of that art, the large quantity of research required to define these unpredictable variables, the lack of guidance provided in the specification, the absence of any working example related to claimed invention and the no teaching in the prior art balanced only against the high skill level in the art, it is the position of the examiner that it would require undue experimentation for one of skill in the art to perform the method of the claim as broadly written.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 30, 32, 36, 38, 40, 42, 44, 47, and 54-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,041,950 B2 wherein a fluorescent dye cannot be considered as a first chromogenic moiety according to applicant’s argument in this allowed application. Although the conflicting claims are not identical, they are not patentably distinct from each other because the examined claims in this instant application are either anticipated by, or would have been obvious over, the reference claims. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and, In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). Although claims 30, 32, 36, 38, 40, 42, 44, 47, and 54-70 in this instant application are not identical to claims 1-20 of U.S. Patent No. 10,041,950 B2, since the content of U.S. Patent No. 10,041,950 B2 teaches that the light in claims 1, 16, and 18 of U.S. Patent No.10,041,950 B2 can be visible light (eg., see column 33) which has a wavelength from 400 nm to 700 nm, “the detection probe is an oligonucleotide probe or an antibody probe. In further illustrative embodiments, the labeling conjugate includes an antibody coupled to the enzyme. Exemplary enzymes include oxidoreductases or peroxidases. An exemplary antibody for the labeling conjugate would be an anti-species or an anti-hapten antibody. The detection probe may include a hapten selected from the group consisting an oxazole hapten, pyrazole hapten, thiazole hapten, nitroaryl hapten, benzofuran hapten, triterpene hapten, urea hapten, thiourea hapten, rotenoid hapten, coumarin hapten, cyclolignan hapten, di-nitrophenyl hapten, biotin hapten, digoxigenin hapten, fluorescein hapten, and rhodamine hapten. In other examples, the detection probe is monoclonal antibody derived from a second species such as goat, rabbit, mouse, or the like. The labeling conjugate is configured, through its inclusion of an anti-species or an anti-hapten antibody to bind selectively to the detection probe” (eg., see column 3, first paragraph), “the signaling conjugate may comprise an optional linker. If a linker is used, it may be selected from any of the linkers disclosed herein. In particular disclosed embodiments, the linker is selected to improve hydrophilic solution solubility of the signaling conjugate, and/or to improve conjugate functionality on the biological sample. In particular disclosed embodiment, the linker is an alkylene oxide linker, such as a polyethylene glycol linker; however, any of the linkers disclosed herein may be used for the signaling conjugate” (eg., see column 33), “[I]n some embodiments, light microscopy is utilized for image analysis. Certain disclosed embodiments involve acquiring digital images, which can be done by coupling a digital camera to a microscope. Digital images obtained of stained samples are analyzed using image analysis software. Color can be measured in several different ways. For example, color can be measured as red, blue, and green values; hue, saturation, and intensity values; and/or by measuring a specific wavelength or range of wavelengths using a spectral imaging camera” (see column 22), “[I]n one embodiment, a signaling conjugate is configured to provide an absorbance peak having a λmax of between about 350 nm and about 800 nm, between about 400 nm and about 750 nm, or between about 400 nm and about 700 nm. These wavelength ranges are of particular interest because they translate into colors visible to humans” (see column 41), and “[C]ertain disclosed embodiments involve acquiring digital images, which can be done by coupling a digital camera to a microscope. Digital images obtained of stained samples are analyzed using image analysis software. Color can be measured in several different ways. For example, color can be measured as red, blue, and green values; hue, saturation, and intensity values; and/or by measuring a specific wavelength or range of wavelengths using a spectral imaging camera” (see column 22), claims 1-20 of U.S. Patent No. 10,041,950 B2 are directed to the same subject matter and fall entirely within the scope of claims 30, 32, 36, 38, 40, 42, 44, 47, and 50-53 in this instant application. In other words, claims 30, 32, 36, 38, 40, 42, 44, 47, and 50-53 in this instant application are anticipated by claims 1-20 of U.S. Patent No.10,041,950 B2.
Response to Argument4
In page 27, second and third paragraphs of applicant’s remarks filed on September 24, 2025, applicant argues that “[A]pplicant respectfully requests that the rejections be held in abeyance pending the indication of otherwise allowable subject matter, at which time the examiner is invited to contact the undersigned to discuss the possible filing of a terminal disclaimer”.
These arguments have been fully considered but they are not persuasive toward the withdrawal of the rejection since applicant has not filed a terminal disclaimer yet.
Conclusion
No claim is allowed.
Applicant is required to file a terminal disclaimer for copending applications 16/856,619 16/856,604, and 16/038,374 if this instant application is allowable.
Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center. The faxing of such papers must conform with the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993)(See 37 CAR § 1.6(d)). The CM Fax Center number is (571)273-8300.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Frank Lu, Ph.D., whose telephone number is (571)272-0746. The examiner can normally be reached on Monday-Friday from 9 A.M. to 5 P.M.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Dr. Anne Gussow, Ph.D., can be reached on (571)272-6047.
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/FRANK W LU/Primary Examiner, Art Unit 1683 November 26, 2025