DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment and Arguments
2. Claims 12-15, 17, 18 and 20-31 are pending.
Claims 12, 15 and 22 have been amended.
Claims 12-15, 17, 18 and 20-31 are examined on the merits with species, (ectodomain/targeting molecules): LFA-1; CD3; CD45; CD28 and scFv(s).
3. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Interpretation
4. Claims 12, 15 and 22 have been amended to no longer recite generic placeholders coupled with functional language, thus are no longer interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function), see In the Claims submitted February 18, 2026.
Withdrawn Grounds of Rejection
Claim Rejections - 35 USC § 112
5. The rejection of claims 12-15, 17, 18 and 20-31 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of Applicant’s arguments set forth in the Remarks submitted February 18, 2026, see pages 16-21.
Claim Rejections - 35 USC § 102
6. The rejection of claim(s) 12-15, 17, 18 and 20-31 under 35 U.S.C. 102(a)(2) as being anticipated by Pule, Martin et al., US 10,604,570 B2 (effectively filed February 4, 2016) is withdrawn in light of amendment to independent claims 12 and 21 and Applicant’s arguments set forth in the Remarks, both submitted February 18, 2026, see pages 24-26.
7. The rejection of claim(s) 12-15, 17, 18 and 20-31 under 35 U.S.C. 102(a)(2) as being anticipated by Suri et al., US 2020/0101142 A1 (effectively filed June 12, 2017) is withdrawn in light of amendment to independent claims 12 and 21 and Applicant’s arguments set forth in the Remarks, both submitted February 18, 2026, see pages 25 and 26.
New and Maintained Grounds of Rejection
Claim Rejections - 35 USC § 112
8. 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.
9. The rejection of claims 12-15, 17, 18 and 20-31 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 is maintained.
Applicant argues “the specification provides explicit support for the now claimed system of activation MPs (aMPs) that are described as CARs that generate cytotoxic activation signals upon binding (e.g., CD3, CD28, CD45, LFA-1 domains), and inhibition MPs (iMPs) that are described as CARs that generate inhibition signals to modulate cytotoxicity. This modulation is expressly disclosed as the system's core function; cytotoxic properties are activated when aMP signals predominate, and are inhibited when iMP signals predominate. Thus, the amended claim language is squarely anchored in the disclosure. The prior written description concerns arose from broader claim formulations that are no longer at issue.
Applicant argues about enablement stating “the disclosure enables the full scope of the pending claims without undue experimentation” and points out paragraphs (paras). and Figures within the specification, see page 11, 2nd para.
In fact, the independent claim is to a system; it does not attempt to claim a genus as described in Abbvie V. Centocor (Fed. Cir. 2014) as purported on page 10 of the Office Action.”, see last sentence on page 11 of the Remarks.
Applicant concludes arguments stating “[t]o further demonstrate that the pending claims are fully supported by the specification as filed, the Applicant provides the table below, which maps each limitation of independent claim 12 to explicit disclosure in the application. This mapping illustrates that every recited structural and functional element-including the ectodomains, transmembrane regions, and endodomains of the activation MPs (aMPs) and inhibition MPs (iMPs), as well as the modulation of cytotoxic and proliferative properties-is expressly described in the specification and depicted in the figures. This table therefore confirms that the present claims are commensurate in scope with the written description, and that the §112 concerns raised in the Office Action are addressed by the amended claim language.”, see Remarks submitted February 18, 2026, page 12, 2nd para.
Foremost, the instant rejection is not an enablement rejection but a written description rejection, wherein the Specification must provide evidence the possession of all these said MPs within a hyperspecific modified protein system. The MPs are undefined and uncharacterized and fall within a potentially large genus and yet to establish possession. Herein, a genus is claimed using functional language to define a desired result,
“the MP system modulating potency of cytotoxic properties of the engineered cell based on a prevalence of the inhibition signals generated due to bound iMPs in the set of iMPs and a prevalence of the activation signals generated due to bound aMPs in the set of aMPs, wherein both the inhibition signals generated by each bound iMP and the activation signals generated by each bound aMP are present in the MP system so that:
(i) the prevalence of the activation signals present in the MP system exceeding the prevalence of the inhibition signals present in the MP system results in activation of the cytotoxic properties, and
(ii) the prevalence of the inhibition signals present in the MP system exceeding the prevalence of the activation signals in the MP system results in inhibition of the cytotoxic properties.”, see claim language bridging pages 3 and 4 of In the Claims submitted February 18, 2026.
The MPs seem to be solely defined by function. Although "functional claim language can meet the written description requirement when the art has established a correlation between structure and function," "merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species." Ariad, 598 F.3d at 1350; see also University of California V. Eli Lilly and Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997) ("A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." (alteration original) (quoting Fiers V. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993))).
"[T]he specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus." Ariad, 598 F.3d at 1349; AbbVie Deutschland GmbH V. Janssen Biotech, Inc., 759 F.3d 1285, 1299 (Fed. Cir. 2014). At this point in time of prosecution Applicant has failed to do such.
The instant disclosure does not provide a structure-function correlation that would allow for a person of ordinary skill in the art to envision all of the possible MPs sequences, particularly in the CDR regions, such that the obtained structure would result in the claimed function(s). Accordingly, the rejection is maintained.
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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 12 reads on a hyperspecific modified protein (MP) system having at least two activation MPs and at least one inhibition MP or having at least one activation MP and at least two inhibition MPs, the system comprising a set of the activation MPs (aMPs) expressed on or in an engineered cell and having first ectodomains that bind to entities expressed by target cells, the first ectodomains connected to aMP endodomains by first transmembrane regions spanning a first membrane of the engineered cell, each aMP endodomain generating cytotoxic activation signals in response to binding of a connected first ectodomain;
a set of the inhibition MPs (iMPs) expressed on or in the engineered cell and having second ectodomains that bind to entities expressed by the target cells, the second ectodomains connected to iMP endodomains by second transmembrane regions spanning the first membrane of the engineered cell, each iMP endodomain generating cytotoxic inhibition signals in response to binding of a connected second ectodomain; and
the MP system modulating potency of cytotoxic properties of the engineered cell based on a prevalence of the inhibition signals generated due to bound iMPs in the set of iMPs the activation signals generated due to bound aMPs in the set of aMPs, wherein both the inhibition signals generated by each bound iMP and the activation signals generated by each bound aMP are present in the MP systym so that:
(i) the prevalence of the activation signals present in the MP system exceeding the prevalence of the inhibition signals present in the MP system results in activation of the cytotoxic properties, and
(ii) the prevalence of the inhibition signals present in the MP system exceeding the prevalence of activation signals in the MP system results in inhibition of the cytotoxic properties.
Claim 22 reads on a hyperspecific MP system having at least two activation MPs and at least one inhibition MP or having at least one activation MP and at least two inhibition MPs (iMPs), the system comprising a set of the aMPs expressed on or in an engineered cell and having first ectodomains that bind to entities expressed by target cells and first endodomains that generate cytotoxic activation signals of the engineered cell in response to binding of a connected first ectodomain;
a set of the iMPs expressed on or in the engineered cell are and having second ectodomains that bind to entities expressed by the target cells and second endodomains that generate cytotoxic inhibition signals of the engineered cell in response to binding of a connected second ectodomain; and
wherein the MP system modulates potency of cytotoxic properties of the engineered cell based on a prevalence of the activation signals generated due to bound aMPs in the set of aMPs and a prevalence of the inhibition signals generated due to bound iMPs in the set of iMPs, wherein both the inhibition signals generated by each bound iMP and the activation signals generated by each bound aMP are present in the MP system so that:
the prevalence of the activation signals present in the system exceeding the prevalence of the inhibition signals present in the system results in activation of the cytotoxic properties, and
the prevalence of the inhibition signals present in the system exceeding the prevalence of the activating activation signals present in the system results in inhibition of the cytotoxic properties.
The written description in this instant case does not set forth a plethora of MPs that are in a MP system solely defined by function and how to adapt the domains such that they operate in said system. This plethora of MPs have not been fully defined and characterized by structure. There is no evidence or showing of any of the MPs that target and activate a genus of target cells, which includes any cell regarded as rapidly dividing. And furthermore, there seems to be no MP system comprising an engineered cell with sets of two types of MPs capable of modulating potency of cytotoxic properties of the engineered cell based on inhibition and activation signals.
While the specification states what a hyperspecific Modified Protein (MP) system can include, the specification does not evidence possession of the system or components, nor identified or characterized the number of species, see page 6, section 0021; page 7, section 0023; and Figures 1 and 2 with descriptions in sections 0025 and 0026 on page 7. Applicant has not met the requirement because it has not been shown the correlation between function and structure, nor a number of species that are representative of the breadth of the genus of MPs.
The written description is not commensurate in scope with the plethora of the different types of MPs that may be expressed or in an engineered cell, nor the target cells they bind, as the target cells thereby generating cytotoxic activation signals of the engineered cells, wherein one type of signal, activation or inhibition overrides the other. The instant application does not provide sufficient guidance as to the nexus or correlation between the structure and function of these different MPs. There seems to be no identifying sequences that would evidence Applicants’ written descriptive support for the genus of MPs, as well as the MP system comprising a cell together with the said MPs encompassed by the claims. The claims, nor the specification do not place the skilled artisan in possession of the relevant identifying characteristics of a genus of molecules commensurate in scope with the claimed invention.
The instant application does not provide sufficient guidance as to the nexus or correlation between the structure and function of the MPs molecules, nor the MP system that places the skilled artisan in possession of the genera of MPs and MP system in scope with the claimed invention.
In Abbvie v. Centocor (Fed. Cir. 2014), the Court held that a disclosure of many different antibodies (in that case neutralizing antibodies to IL-12 with a particular binding affinity) was not enough to support the genus of all IL-12 neutralizing antibodies because the disclosed antibodies were very closely related to each other in structure and were not representative of the full diversity of the genus. The Court further noted that functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support especially in technology fields that are highly unpredictable where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus.
“A sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus.” See AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69.
Vas-Cath Inc. V Mahurkar, 19 U5PQ2d 1111, clearly states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. 112 is severable from its enablement provision (see page 115).
The skilled artisan cannot envision the detailed structure of the broad class of MPs that are remiss of sequences, therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and a reference to a potential method of isolating it. The polypeptide itself is required. See Fiers v. Revel, 25 U5PQ 2d 1601 at 1606 (CAFC1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Lts. 18 U5PQ2d 1016.
Furthermore, In The Reagents of the University of California v. Eli Lilly (43 U5PQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that while Applicants are not required to disclose every species encompassed by a genus, the description of a genus is achieved by the recitation of a representative number of DNA molecules, usually defined by a nucleotide sequence, falling within the scope of the claimed genus. At section B(l), the court states that "An adequate written description of a DNA...'requires a precise definition, such as by structure, formula, chemical name, or physical properties', not a mere wish or plan for obtaining the claimed chemical invention".
At the time the application was filed Applicants do not seem to be in possession of all the members of the genus of MPs. Applicants did not have possession of the breadth of these molecules.
The USPTO has released a Memo on the Clarification of Written Description Guidance For Claims Drawn to Antibodies and Status of 2008 Training Materials, 02/22/2018. See https://www.uspto.gov/sites/default/files/documents/amgen_22feb2018.pdf.
There is insufficient written description of the required kind of structure-identifying information about the corresponding makeup of MPs essential to the claimed invention to demonstrate possession that fulfill the requirements of a structure-function relationships of written description. Also, see Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017).
The instant disclosure, including the claims fail to disclose a representative number of species falling with the scope of the genera and/or structural common to the members of the genera so the one of skill in the art can visualize or recognize the members of the genus of MPs and the hyperspecific MP system.
Also, it is not enough for the specification to show how to make and use the invention, i.e., to enable it (see Amgen at page 1361).
An adequate written description must contain enough information about the actual makeup of the claimed products – “a precise definition, such as structure, formula, chemic name, physical properties of other properties, of species falling with the genus sufficient to distinguish the gene from other materials”, which may be present in “functional terminology when the art has established a correlation between structure and function” (Amgen page 1361).
A skilled artisan cannot, as one can do with a fully described genus, visualize or recognize the identity of the members of the genus that exhibit this functional property, i.e., bind different entities.
The specification does not evidence the possession of all the MPs that are undefined and uncharacterized falling within the potentially large genus to establish possession. Consequently, Applicant was not in possession of the instant claimed invention. See University of California v. Eli Lilly and Co. 43 U5PQ2d 1398.
The full breadth of the claims do not meet the written description provision of 35 U.S.C. 112, first paragraph.
Claim Rejections - 35 USC § 103
10. 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.
11. Claim(s) 12-15, 17, 18 and 20-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Suri et al., US 2020/0101142 A1 (effectively filed June 12, 2017), and further in view of Fedorov et al. (Sci. Transl. Med. 5(215): 215ra72, 1-25, December 11, 2013). Suri teaches chimeric antigen receptors (CARs) comprising “…an extracellular target moiety, a hinge,… transmembrane domain and an intracellular domain;”, see page 3, section 0022; unit 5 beginning on page 144. There may be three or more CARs, which can include at
least three ectodomains or targeting moieties, see page 5, section 0054; page 179, section 0298; and page 66, section 0183.
The three components, targeting moiety (also known as ectodomain), transmembrane domain and intracellular signaling domain (also known as the endodomain) may be constructed in
a single fusion polypeptide, see page 179, section 0298. More than one CAR fusion polypeptide may be present and there may be more than three or more CARs, see page 179, section 0298. Suri teaches “the singular forms include plural unless the context clearly dictates otherwise”, see page 5, section 0054. Suri goes on to teach cells engineered to express a CAR including more than 1, multiple CARs, two, there or more, see page 144, section 0295; and page 179, section 0298. And in regards to size, the claims do limit or account for payload size.
The extracellular target moiety reads on Applicants’ ectodomain, wherein “the extracellular target moiety of the CAR may be [a single chain Fv] scFv…”, see page 3, section 0023. The scFV antibody is a targeting moiety that is capable of recognizing several different molecules including tumor specific antigens (TSAs), see page 146, sections 0267 and 0269-0279.
The extracellular targeting domain is capable of binding numerous tumor specific antigens and joined through the hinge (also called space domain or spacer) and transmembrane regions to an intracellular signaling domain, see page 144, section 0259; and page 145, section 0271. “[T]he hinge and transmembrane domain of the CAR may be paired”, see page 3, section 0023. “[H]inge [domains] may be present at the N terminus of the transmembrane domain” and “…separate the scFv [ectodomain/targeting domain] from the cell membrane in the CAR”, see page 178, section 0296; and page 207, section 0308.
The intracellular domain with co-stimulatory domains reads on Applicants’ endodomain. This endodomain may have one of these activation and inhibitory molecules, as well as multiple molecules, such as CD28, CD45, CD3 (gamma, delta, epsilon), 4-1BB (CD137), CD27, OX40 (CD134), glucocorticoid-induced tumor necrosis factor receptor (GITR), CD30 and CD40, see page 3, sections 0022 and 0023; and page 163, section 0288.
Suri does not explicitly teach the hyperspecific MP system comprising a cell with at least two activation CARs and at least one inhibition CAR or at least two inhibition CARs and at least one activation CAR, wherein the three or more different types of MPs operate together in a system.
However, Federov teaches CTLA-4- and PD-1-based inhibitory chimeric antigen receptors (iCARs), as well as an activation CAR, 19-28z, see abstract; and iCARs can inhibit…section beginning on page 5. An iCAR and an activation CAR can be expressed together on cells, see iCARs can inhibit…section. It would have been obvious before the effective filing date to utilize the teachings of Suri to arrive at a hyperspecific MP system including a cell expressing or within a cell three or more different types of MPs, comprising at least two activation CARs and at least one inhibition CAR or at least two inhibition CARs and at least one activation CAR because both documents teach how to manufacture CARs with specific functions, i.e. mediate T cell responses for effective cancer treatment, see both documents, particularly Federov. It would have further been obvious before the effective filing date to utilize the teachings of Suri that immune cells such as T and NK cells can be engineered to express a CAR including multiple co-stimulatory domains, as well as more CARs, see Figures 13-18; section 5. Beginning on page 144; and page 163, section 0288.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by teachings in Suri and Federov to engineer cells with the said distinct population of CARs in a balance based system in order to limit, modify, activate or inhibit a cascade of events or activities mediated by the activation CAR and/or inhibition CAR, which impact and/or influence immunotherapy responses, see both documents in their entireties, particularly Fedorov.
12. Claim(s) 12-15, 17, 18 and 20-31 are rejected under 35 U.S.C. 103 as being unpatentable over Pule, Martin et al., US 10,604,570 B2 (effectively filed February 4, 2016), and further in view of Fedorov et al. (Sci. Transl. Med. 5(215): 215ra72, 1-25, December 11, 2013, corresponds to IDS reference #5 submitted October 25, 2021). Pule teaches “…a chimeric antigen-receptor (CAR) signalling system comprising: (i) a targeting component comprising an antigen-binding domain, a transmembrane domain and a first heterodimerization domain; and (ii) an intracellular signalling component comprising a signalling
domain and a second heterodimerization domain” expressed by a cell, see abstract; column 2, line 59-column 3, line 4; column 4, lines 60-62; and column 5, line 6. the Pule patent “the cell may comprise at least one targeting component…one, two, three, four, five, up to a plurality of targeting components…”, see column 18, lines 60-63. The targeting component is included within the CAR, hence Pule does teach at least three CARs, see abstract. And in regards to size, the claims do limit or account for payload size.
Single chain variable fragments (scFv) are the most common form of a CAR and are able to “…recognize a target antigen, fused via a spacer and a trans-membrane domain to a signalling endodomain”, see column 1, lines 48-52; column 7, lines 49-64; column 11 lines 4-53.
“The CAR signalling system may comprise multiple targeting components, each recognizing a different antigen”, see column 3, lines 14 and 15. A single targeting component is able to heterodimerize with more than two signalling components, see column 3, lines 40-47. The CAR
system may comprise more than one targeting component, such as multiple targeting components with each recognizing a different antigen, see column 3, lines 14 and 15; column 13, lines, 20-47. The signalling domain of Pule is the equivalent of the endodomain and a CAR signalling system
may comprise a plurality of signalling components and signalling endodomains, see column 3, lines 20-39. The signalling domain/endodomain of Pule contain the activation and/or inhibitory molecules, absent evidence to the contrary. The taught plurality of signalling endodomains
include at least one activation molecule and at least one inhibitory molecule, as well as at least three, see column 3, lines 14-67. The endodomain may be CD3 zeta endodomain, CD28 endodomain and/or CD28 endodomain, see column 3, lines 20-28.
Pule does not explicitly teach the hyperspecific MP comprises a cell with at least two activation CARs and at least one inhibition CAR or at least two inhibition CARs and at least one activation CAR, wherein the three or more different types of MPs operate together.
However, Federov teaches CTLA-4- and PD-1-based inhibitory chimeric antigen receptors (iCARs), as well as an activation CAR, 19-28z, see abstract; and iCARs can inhibit…section beginning on page 5. An iCAR and an activation CAR can be expressed together on cells, see iCARs can inhibit…section. It would have been obvious before the effective filing date to utilize the teachings of Pule to arrive at a hyperspecific MP system including a cell expressing or within a cell three or more different types of MPs, comprising at least two activation CARs and at least one inhibition CAR or at least two inhibition CARs and at least one activation CAR because both documents teach how to manufacture CARs with specific functions, i.e. mediate T cell responses for effective cancer treatment, see both documents, particularly Federov. It would have further been obvious before the effective filing date to utilize the teachings of Pule the CAR signalling system may be comprised or expressed by a cell including “…a plurality of different signalling molecules and different signalling domain(s)…on separate signally components” with each proximal to the membrane”, see column 4, lines 60-67; and Multiple…section beginning in column 15.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by teachings in Pule and Federov to engineer cells with the said distinct population of CARs in a balance based system in order to limit, modify, activate or inhibit a cascade of events or activities mediated by the activation CAR and/or inhibition CAR that impact immunotherapy responses, see both documents in their entireties, particularly Fedorov.
Conclusion
13. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
14. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ALANA HARRIS DENT whose telephone number is (571)272-0831. The Examiner works a flexible schedule, however she can generally be reached between 8AM-8PM, Monday through Friday.
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, Julie Wu can be reached on 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ALANA HARRIS DENT
Primary Examiner
Art Unit 1643
25 May 2026
/Alana Harris Dent/Primary Examiner, Art Unit 1643
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