DETAILED ACTION
Status of the Application
Claims 1-2, 5-17, 21, 23, 25-26 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment of claim 16 as submitted in a communication filed on 6/5/2026 is acknowledged.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/5/2026 has been entered.
Claims 1-2, 5-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 without traverse in the reply filed on 12/20/2019. Claims 16-17, 21, 23, 25-26 have been examined only to the extent they encompasses the polypeptide of SEQ ID NO: 591.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
Claim Objections
Claim 16 is objected to due to the recitation of “….iii) a nucleic acid molecule comprising a detectable label….component, and, iv) Mg2+, v) a pH buffer; and vi) a salt. To enhance clarity and to be consistent with commonly used claim language, the term should be amended to recite “….iii) a nucleic acid molecule comprising a detectable label….component, iv) Mg2+, v) a pH buffer; and vi) a salt”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a) or First Paragraph (pre-AIA )
Claims 16-17, 21, 23, 25-26 remain 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This rejection is necessitated by the introduction new matter.
As set forth in MPEP 2163 (I)(B), new or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not necessarily described by a genus encompassing it and a species upon which it reads). Claim 16 and dependent claims 17, 21, 23, 25-26 as amended now require an engineered composition that consists of six components, a Cas polypeptide, a nucleic acid component that forms a complex with the Cas polypeptide, a nucleic acid that comprises a detectable label which is not complementary to the nucleic acid component that forms a complex with the Cas polypeptide, Mg2+, a pH buffer, and a salt. While the Examiner has found support for an engineered composition that comprises a Cas polypeptide, a nucleic acid component that forms a complex with the Cas polypeptide and a nucleic acid comprising a detectable label which is not complementary to the nucleic acid component that forms a complex with the Cas polypeptide, the Examiner is unable to find support for an engineered composition that consists of six components, namely a Cas polypeptide, a nucleic acid component that forms a complex with the Cas polypeptide, a nucleic acid that comprises a detectable label and is not complementary to the nucleic acid component that forms a complex with the Cas polypeptide, Mg2+, a pH buffer, and a salt. Thus, there is no indication that an engineered composition that consists of six components, wherein said components are a Cas polypeptide, a nucleic acid component that forms a complex with the Cas polypeptide, a nucleic acid that comprises a detectable label and is not complementary to the nucleic acid component, Mg2+, a pH buffer, and a salt, was within the scope of the invention as conceived by Applicant at the time of the invention. Accordingly, Applicant is required to cancel the new matter in the response to this Office Action.
Applicant states that the specification discloses the claimed composition, namely a Cas polypeptide with HEPN domains and RNase activity, a nucleic acid component that directs sequence specific target RNA binding, a nucleic acid molecule comprising a detectable label not complementary to the nucleic acid component, Mg2+, a pH buffer, and a salt. Applicant states that the Office never addressed the section of the specification under the heading “C2c2 cleaves collateral RNA in addition to crRNA-targeted ssRNA” that describes the six components of the claimed composition, citing Figure 124A, paragraph [00996] and paragraph [001016]. Applicant states that the nuclease assay buffer of paragraph [001016] is the buffer the specification itself designates as governing the collateral cleavage experiments. Applicant states that the nuclease assay in paragraph [001016] consists of 40 mM Tris-HCL as the buffer component, 60 mM NaCl as the salt component and 6 mM MgCl2 providing Mg2+. Applicant states that one of skill in the art would understand that the collateral cleavage experiments disclosed were conducted in that buffer. Therefore, Applicant is of the opinion that the specification describes all the six components currently recited. Applicant states that Figures 140A and 140B independently corroborate the collateral cleavage section’s description of the same experimental composition, citing the captions of said Figures. Applicant states that the collateral cleavage section taken together with the expressly designated nuclease assay methodology of paragraph [001016] reasonably convey to one of skill in the art that the inventor possessed the claimed composition.
Applicant’s arguments have been fully considered but not deemed persuasive to avoid the rejection of claims 16-17, 21, 23, 25-26. The Examiner acknowledges the amendments made to claim 16. However, the Examiner disagrees with Applicant’s contention that the claimed composition finds support in the specification as originally filed.
While it is agreed that the specification discloses compositions for targeting nucleic acids that comprise a Type VI CRISPR-Cas loci effector protein and one or more nucleic acid components (paragraph [0013]), the issue in the instant case is whether a composition consisting of 6 components, wherein said 6 components are limited to a Cas polypeptide, a nucleic acid component that forms a complex with the Cas polypeptide, a nucleic acid that comprises a detectable label and is not complementary to the nucleic acid component, a pH buffer, a salt and Mg2+ ions has been disclosed in the specification as originally filed, or has been disclosed as a preferred embodiment of the genus of compositions comprising a Type VI CRISPR-Cas loci effector protein and one or more nucleic acid components. As previously indicated, the term “comprising” is open language while the term “consisting of” is closed language. There is no mention of a composition that only has the recited six components in the specification.
With regard to the argument that the Office never addressed the section of the specification under the heading “C2c2 cleaves collateral RNA in addition to crRNA-targeted ssRNA” that allegedly describes the six components of the claimed composition, citing Figure 124A, paragraph [00996] and paragraph [001016], it is noted that Applicant’s prior response of 12/10/2025 never referred to paragraph [00996]. Thus, the Examiner did not have to address such paragraph. Paragraph [01016], which was previously referred to in the response of 12/10/2025, was fully considered and addressed. As previously stated, paragraph [01016] discloses nuclease assays performed with labeled target single stranded RNA, a C2c2 protein from Leptotrichia shahii (Cas polypeptide), and crRNA in the presence of a buffer having a specific composition, without any mention of a nucleic acid that comprises a detectable label and is not complementary to the crRNA (nucleic acid component) that forms a complex with the C2c2 protein. The labeled target single stranded RNA is complementary to the crRNA (nucleic acid component). With regard to paragraph [00996], while it is agreed that this paragraph discloses an assay where it is shown that C2c2 cleaves collateral RNA in addition to crRNA-targeted ssRNA as well as a composition that comprises a LshC2c2 (Cas polypeptide), a guide RNA (crRNA), a target RNA, and unrelated RNA molecules that are not complementary to the guide RNA, there is no mention in this paragraph of a composition that consists solely of the LshC2c2 (Cas polypeptide), the guide RNA, a nucleic acid that has a detectable label and is not complementary to the guide RNA, a pH buffer, a salt and Mg2+ ions. Also, while paragraph [00996] refers to Figure 124A, the caption of Figure 124A is silent with regard to a pH buffer, a salt or Mg2+. Furthermore, while it is agreed that the nuclease assay buffer of paragraph [001016] comprises Tris-HCl, NaCl and MgCl2, the composition of the claims requires a genus of Cas polypeptides and a genus of pH buffers and salts. While the argument can be made that the nuclease assay buffer could have been used in the assay of paragraph [00996], it is noted that there is no indication whatsoever that the composition disclosed in paragraph [00996] is limited solely to the six components recited in claim 16. With regard to Figures 140A and 140B and their corresponding captions, it is noted that the text of the captions state “Biochemical characterization of the collateral cleavage effect. (A) LshCc2 is incubated with a crRNA targeting protospacer 14 with and without unlabeled ssRNA target 1 (contains protospacer 14). When LshC2c2 is in the presence of target 1, significant cleavage activity is observed for fluorescently labeled non-complementary targets 6-9. (B) HEPN mutant collateral activity is compared to WT C2c2. The proteins are incubated with crRNA complementary to protospacer 14 and with and without unlabeled homopolymer targets 2 or 3 (both containing protospacer 14). The collateral effect is no longer observed with the HEPN mutant proteins on the fluorescently labeled non-complementary target 8.”. While one could reasonably conclude that this text discloses a composition that comprises LshC2c2, a crRNA, a target ssRNA, and fluorescently labeled non-complementary targets, there is no mention whatsoever of a pH buffer, a salt or Mg2+, let alone a composition that consists solely of the 6 components recited in claim 16.
Thus, for the reasons stated above, one would have to conclude that there is no indication that an engineered composition that consists of six components, namely a Cas polypeptide, a nucleic acid component that forms a complex with the Cas polypeptide, a nucleic acid that comprises a detectable label, wherein the nucleic acid is not complementary to the nucleic acid component, a pH buffer, a salt and Mg2+ was within the scope of the invention as conceived by Applicant at the time of the invention.
Double Patenting
Claims 16-17, 21, 23, 25-26 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-8 of U.S. Patent No. 11,174,515.
This rejection has been discussed at length in prior Office actions. It is maintained for the reasons of record and those set forth below.
Applicant argues that claims 7-8 of U.S. Patent No. 11,174,515 affirmatively recite nucleic acid amplification reagents as a required claim element while the instant claims do not include nucleic acid amplification reagents. Applicant states that the instant claims require Mg2+, a pH buffer and a salt. Applicant states that arriving at the claimed composition from claims 7-8 of U.S. Patent No. 11,174,515 requires eliminating the amplification reagents required by the ‘515 claims and substituting a standalone buffer composition in their place. Applicant submits that the Examiner’s analysis stops at component mapping and fails to explain why a person of ordinary skill in the art starting from the ‘515 claimed system would have eliminated the required amplification reagents and substituted the closed Mg2+/pH buffer/salt composition recited in the instant claims. Applicant states that under MPEP § 804(II)(B)(1), the reference specification may be consulted to interpret the reference claims but may not supply claim limitations the reference claims do not recite.
Applicant’s arguments have been fully considered but not deemed persuasive to overcome the instant rejections. Claims 16-17, 21, 23, 25-26 of the instant application as amended are directed in part to an engineered composition that consists of six components, wherein said components are a Cas protein that comprises SEQ ID NO: 591, a nucleic acid component that forms a complex with the Cas polypeptide and directs the complex to bind a target RNA, a nucleic acid that comprises a detectable label and is not complementary to the nucleic acid component, Mg2+, a pH buffer and a salt, wherein the Cas protein has RNase activity, wherein the Cas protein has two HEPN domains separated by a mixed alpha/beta region, wherein one of the HEPN domains is near the C-terminal end of the Cas protein.
Claims 7-8 of U.S. Patent No. 11,174,515 are directed in part to a nucleic acid detection system that has a Cas13 protein which is a C2c2 protein from Leptotrichia shahii or Leptotrichia wadei F0279, one or more guide polynucleotides capable of binding to a target nucleic acid, wherein the target nucleic acid is found in a mammalian cell, an RNA-based masking construct (nucleic acid that does not hybridize to the guide polynucleotide), and nucleic acid amplification reagents.
With regard to the argument that arriving at the claimed composition from claims 7-8 of U.S. Patent No. 11,174,515 requires eliminating the amplification reagents required by the ‘515 claims and substituting a standalone buffer composition in their place, it is noted that according to the specification of U.S. Patent No. 11,174,515, nucleic acid amplification regents include a pH buffer (buffer that comprises Tris), and magnesium chloride which is a salt that provides Mg2+ions. Therefore, contrary to Applicant’s assertions, there is no elimination of the amplification reagents required by the claims of U.S. Patent No. 11,174,515 when the specification of such patent specifically states that nucleic acid amplification regents include a pH buffer (buffer that comprises Tris), and magnesium chloride (salt) which is a salt that provides Mg2+ions.
As previously stated, the specification of U.S. Patent No. 11,174,515 discloses the amino acid sequence of SEQ ID NO: 477 as the amino acid sequence of the C2c2 protein from Leptotrichia shahii recited in the claims. SEQ ID NO: 477 is identical to SEQ ID NO: 591 of the instant application. The specification of U.S. Patent No. 11,174,515 discloses the amino acid sequence of SEQ ID NO: 12 as the amino acid sequence of the C2c2 protein from Leptotrichia wadei F0279 recited in the claims. SEQ ID NO: 12 is identical to SEQ ID NO: 587 of the instant application. The proteins of SEQ ID NO: 477 and 12 of U.S. Patent No. 11,174,515 are Leptotrichia shahii and Leptotrichia wadei F0279 C2c2 proteins as recited in the claims of U.S. Patent No. 11,174,515. The specification of U.S. Patent No. 11,174,515 also discloses an RNA-based masking construct (nucleic acid that does not hybridize to the nucleic acid component) that comprises an RNA oligonucleotide linked to a detectable ligand (label) as a preferred embodiment of the genus of masking constructs required in the system of claims 7-8 of U.S. Patent No. 11,174,515 as evidenced by claim 13 of U.S. Patent No. 11,174,515. The nucleic acid detection system of claims 7-8 of U.S. Patent No. 11,174,515 requires six components, namely a Cas polypeptide which is a C2c2 protein from Leptotrichia shahii and Leptotrichia wadei F0279 (called CRISPR effector protein in U.S. Patent No. 11,174,515), a nucleic acid component (called guide RNA in U.S. Patent No. 11,174,515), a nucleic acid that is not complementary to the nucleic acid component (called RNA-based masking construct in U.S. Patent No. 11,174,515), as well as a pH buffer, a salt and Mg2+ in view of the fact that the nucleic acid amplification reagents include a pH buffer (Tris buffer), magnesium chloride (a salt) and Mg2+ ions. Therefore, a composition (system) that consists of the Cas polypeptide of SEQ ID NO: 591 (L. shahii C2c2 protein), a nucleic acid component that forms a complex with the Cas polypeptide of SEQ ID NO: 591 (guide polynucleotide), a nucleic acid molecule that comprises a detectable label which is not complementary to the nucleic acid component (RNA-masking construct), a pH buffer, a salt and Mg2+ ions would be an obvious variation of the system of claims 7-8 of U.S. Patent No. 11,174,515 in view of the fact that the L. shahii C2c2 protein comprises SEQ ID NO: 591 as evidenced by the specification of 11,174,515 and the nucleic acid amplification reagents includes a pH buffer (Tris buffer), magnesium chloride and Mg2+ ions.
With regard to the argument that MPEP § 804(II)(B)(1) states that the reference specification may be consulted to interpret the reference claims but may not supply claim limitations the reference claims do not recite, it is noted that the Examiner has not used the specification of U.S. Patent No. 11,174,515 to supply claim limitations that the reference claims do not recite. As stated in MPEP § 804(II)(B)(1), those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). Moreover, MPEP § 804(II)(B)(1) specifically states that one is not precluded from all use of the reference patent or application disclosure to understand the meaning of the reference claims and that the portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In the instant case, the Examiner has previously stated that the proteins of SEQ ID NO: 477 and 12 in U.S. Patent No. 11,174,515 provide support to the genus of C2c2 proteins recited in claims 7-8, and that a labeled RNA-masking construct is clearly encompassed by the claims by being disclosed as a preferred embodiment of the genus of RNA-masking constructs. In addition, it is reiterated herein that the specification of U.S. Patent No. 11,174,515 specifically states that the nucleic acid amplification reagents includes a pH buffer (buffer that comprises Tris), and magnesium chloride which is a salt that provides Mg2+ions. As such, based on the specification of U.S. Patent No. 11,174,515, the term “nucleic acid amplification reagents” as recited in the claims of U.S. Patent No. 11,174,515 encompasses a pH buffer, a salt and Mg2+ ions.
Therefore, for the reasons of record and those set forth above, one would reasonably conclude that the claimed invention is unpatentable over claims 7-8 of U.S. Patent No. 11,174,515 on the ground of nonstatutory double patenting.
Claims 16-17, 21, 23, 25-26 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,266,886. In the alternative, claims 16-17, 21, 23, 25-26 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,266,886 in view of Podolska et al. (Journal of Biomolecular Screening 19(3):417-426, first published 8/14/2013).
This rejection has been discussed at length in prior Office actions. It is maintained for the reasons of record and those set forth below.
Applicant argues that claims 1-8 of U.S. Patent No. 10,266,886 affirmatively recite nucleic acid amplification reagents as a required claim element while the instant claims do not include nucleic acid amplification reagents. Applicant states that the instant claims require Mg2+, a pH buffer and a salt. Applicant states that arriving at the claimed composition from claims 1-8 of U.S. Patent No. 10,266,886 requires eliminating the amplification reagents required by the ‘886 claims and substituting a standalone buffer composition in their place. Applicant submits that the Examiner’s analysis stops at component mapping and fails to explain why a person of ordinary skill in the art starting from the ‘886 claimed system would have eliminated the required amplification reagents and substituted the closed Mg2+/pH buffer/salt composition recited in the instant claims. Applicant states that under MPEP § 804(II)(B)(1), the reference specification may be consulted to interpret the reference claims but may not supply claim limitations the reference claims do not recite.
Applicant’s arguments have been fully considered but not deemed persuasive to overcome the instant rejections. As indicated above, claims 16-17, 21, 23, 25-26 of the instant application as amended are directed in part to an engineered composition that consists of six components, wherein said components are a Cas protein that comprises SEQ ID NO: 591, a nucleic acid component that forms a complex with the Cas polypeptide and directs the complex to bind a target RNA, a nucleic acid that comprises a detectable label and is not complementary to the nucleic acid component, Mg2+, a pH buffer and a salt, wherein the Cas protein has RNase activity, wherein the Cas protein has two HEPN domains separated by a mixed alpha/beta region, wherein one of the HEPN domains is near the C-terminal end of the Cas protein.
Claims 1-8 of U.S. Patent No. 10,266,886 are directed in part to a system that comprises reagents for amplifying a target nucleic acid, an RNA construct that comprises a non-target sequence (not complementary to the nucleic acid component), a Cas13a protein (has two HEPN domains), a guide polynucleotide that binds to the Cas13a protein and forms a complex with the Cas13a protein, wherein the Cas13a protein comprises one or more HEPN domains, wherein the Cas13a protein cleaves the RNA construct comprising the non-target sequence, wherein the Cas13a comprises one or more HEPN domains, and wherein the Cas13a protein cleaves the RNA construct that comprises the non-target sequence. According to the specification of U.S. Patent No. 10,266,886, the target RNA is complementary to the guide polynucleotide and the non-target RNA is not complementary to the guide polynucleotide.
With regard to the argument that arriving at the claimed composition from claims 1-8 of U.S. Patent No. 10,266,886 requires eliminating the amplification reagents required by the ‘886 claims and substituting a standalone buffer composition in their place, it is noted that according to the specification of U.S. Patent No. 10,266,886, nucleic acid amplification regents include a pH buffer (buffer that comprises Tris), and magnesium chloride which is a salt that provides Mg2+ions. Therefore, contrary to Applicant’s assertions, there is no elimination of the amplification reagents required by the claims of U.S. Patent No. 10,266,886 when the specification of such patent specifically states that nucleic acid amplification regents include a pH buffer (buffer that comprises Tris), and magnesium chloride (salt) which is a salt that provides Mg2+ions.
As previously stated, the specification of US Patent No. 10,266,886 discloses a. L. shahii DSM 19757 C2c2 protein that comprises SEQ ID NO: 591 as one of the preferred embodiment of the genus of Cas proteins in the systems (SEQ ID NO: 591 in the instant application is identical to SEQ ID NO: 591 in U.S. Patent No. 10,266,886). Furthermore, the specification of US Patent No. 10,266,886 discloses a labeled non-target RNA as a preferred embodiment of the genus of RNA constructs comprising a non-target sequence. The system of claims 1-8 of U.S. Patent No. 10,266,886 has six components, namely a Cas polypeptide (Cas13a in claim 6 in U.S. Patent No. 10,266,886), a nucleic acid component (called guide polynucleotide in U.S. Patent No. 10,266,886), a nucleic acid that does not hybridize to the nucleic acid component (called RNA construct that has a non-target sequence in U.S. Patent No. 10,266,886), as well as a pH buffer, a salt and Mg2+ in view of the fact that the nucleic acid amplification reagents include a pH buffer (Tris buffer), magnesium chloride (a salt) and Mg2+ ions. Therefore, a composition (system) that consists of the Cas polypeptide of SEQ ID NO: 591 (L. shahii C2c2 protein), a nucleic acid component that forms a complex with the Cas polypeptide of SEQ ID NO: 591 (guide polynucleotide), a nucleic acid molecule that comprises a detectable label which is not complementary to the nucleic acid component (RNA-masking construct), a pH buffer, a salt and Mg2+ ions would be an obvious variation of the system of claims 1-8 of U.S. Patent No. 10,266,886 in view of the fact that the protein of SEQ ID NO: 591 is a species disclosed in U.S. Patent No. 10,266,886 that provides support to the genus of Cas13 recited in the claims, a labeled RNA construct that has a non-target sequence is a preferred embodiment of the genus of RNA constructs that have a non-target sequence, and the nucleic acid amplification reagents include a pH buffer, magnesium chloride and Mg2+ ions.
With regard to the argument that MPEP § 804(II)(B)(1) states that the reference specification may be consulted to interpret the reference claims but may not supply claim limitations the reference claims do not recite, it is noted that the Examiner has not used the specification of U.S. Patent No. 10,266,886 to supply claim limitations that the reference claims do not recite. As stated in MPEP § 804(II)(B)(1), those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). Moreover, MPEP § 804(II)(B)(1) specifically states that one is not precluded from all use of the reference patent or application disclosure to understand the meaning of the reference claims and that the portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In the instant case, the Examiner has previously stated that the protein of SEQ ID NO: 591 in U.S. Patent No. 10,266,886 provide support to the genus of C2c2 proteins recited in claims 1-8, and that a labeled RNA construct that has a non-target sequence is clearly encompassed by the claims as a preferred embodiment. In addition, it is reiterated herein that the specification of U.S. Patent No. 10,266,886 specifically states that the nucleic acid amplification reagents includes a pH buffer (buffer that comprises Tris), and magnesium chloride which is a salt that provides Mg2+ions. As such, based on the specification of U.S. Patent No. 10,266,886, the term “nucleic acid amplification reagents” as recited in the claims of U.S. Patent No. 10,266,886 encompasses a pH buffer, a salt and Mg2+ ions.
Therefore, for the reasons of record and those set forth above, one would reasonably conclude that the claimed invention is unpatentable over claims 1-8 of U.S. Patent No. 10,266,886 on the ground of nonstatutory double patenting.
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.
Conclusion
No claim is in condition for allowance.
Applicant is advised that any Internet email communication by the Examiner has to be authorized by Applicant in written form. See MPEP § 502.03 (II). Without a written authorization by Applicant in place, the USPTO will not respond via Internet email to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Sample written authorization language can be found in MPEP § 502.03 (II). An Authorization for Internet Communications in a Patent Application or Request to Withdraw Authorization for Internet Communications form (SB/439) can be found at https://www.uspto.gov/patent/forms/ forms-patent-applications-filed-or-after-september-16-2012, which can be electronically filed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DELIA M RAMIREZ, Ph.D., whose telephone number is (571) 272-0938. The examiner can normally be reached on Monday-Friday from 8:30 AM to 5:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert B. Mondesi, can be reached at (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/DELIA M RAMIREZ/Primary Examiner, Art Unit 1652
DR
June 26, 2026
Prosecution Insights