CTNF 18/258,758 CTNF 97534 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. DETAILED ACTION Election/Restrictions Applicant’s election without traverse of Group I, claims 1-16 and species: SEQ ID NOs: 54, 33, 41, 44, 52, 20, 59, 60, Fab fragment, Alzheimer’s disease, and a method of treating a neurodegenerative disease in a human in the reply filed 03/03/2026 is acknowledged. Claims 17-19 and 24 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and species, there being no allowable generic or linking claims. Election was made in the reply filed 03/03/2026. Claims 1-16 are now under consideration in the instant Office Action. Information Disclosure Statement 06-49-06 AIA The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. Claim Rejections - 35 USC § 112 07-30-02 AIA The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 Claims 1-16 are rejected 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. Instant claims 1-16 recite “a monoclonal antibody directed against fibrils of amyloid beta”. The terminology “directed against” is unclear as it is not determined by the claim if the antibody binds to amyloid beta, or performs another function at the antigen site. Applicant is encouraged to use terminology such as “that binds to” to obviate this rejection. With regard to claims 6-9, the claims are considered indefinite for the recitation of “an amino acid sequence” when referring to heavy/light chain variable domain sequences, respectively. The claim language of “an amino acid sequence” is ambiguous because it indicates any sequence of a recited SEQ ID NO could satisfy the claim limitation, from the full-length sequence to any portion of the sequence (i.e., fragments). As such, it is unclear as to what the scope of the claim is regarding “an amino acid sequence” claim language. This rejection can be obviated by amending the claims to incorporate closed claim language with regard to sequences instead of the “an amino acid sequence” language. For example, closed claim language of “ the amino acid sequence that is at least 95% identical to SEQ ID NO” clearly indicates that the full-length of the recited SEQ ID NO is required to meet the claim limitation. 07-30-01 AIA 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. 07-31-01 Claims 1-16 are 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 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. The claims are drawn to a monoclonal antibody directed against fibrils of amyloid beta peptides, wherein the antibody comprises a heavy chain comprising a heavy chain variable region (VH) comprising a complementarity determining region (CDRs), HCDR1, HCDR2, and HCDR3 and a light chain variable region (VL) comprising complementarity determining regions (CDRs) LCDR1, LCDR2, and LCDR3 with the indicated substitutions recited in instant claim 1, the combinatorial fashion of claiming the CDRs in instant claims 2-5, and the varied percent identities of instant claims 6-9. The instant specification describes identification of seventeen anti-amyloid beta peptide antibodies on page 20-21 in Table 1. Included in these antibodies is the 97A34 and 97A35 antibody, wherein this antibody comprises the heavy chain variable region of SEQ ID NO: 52 and the light chain variable region of SEQ ID NO: 20. With respect to independent instant claim 1, it is noted that the claim reads on antibodies comprising a large number of possible amino acid substitutions at various recited positions of HCDR1, HCDR2, LCDR1, LCDR2, and LCDR3 because “at least one amino acid residue of SEQ ID NO: [X] is replaced with a different amino acid residue”. The substitution of any amino acid residue with any amino acid broadens the scope of the claim to include antibodies with as little as a few amino acid residues in common, which generates a wide, unknown number of CDRs that would fit this functional description. Additionally, there is no sequence listed for HCDR3 which is required for antibody binding and the language of the claims indicates that only one of 6 CDRs is required to describe the antibody, and of those six, they can be claimed in a combinatorial fashion of randomly selecting 6 CDRs from a list to create an antibody. Table 1 lists only seventeen antibodies out of the many possible antibodies that could be produced from the possible combinations recited in instant claim 1. Although the specification discloses that the antibodies of Table 1 bind amyloid beta, it would not have been predictable that antibodies arising from other possible combinations encompassed by instant claim 1 would also bind amyloid beta, as required by independent instant claim 1. In the instant case, it is known in the art that single substitutions of a given CDR sequence can have unexpected effects on antibody binding, as evidenced by Rudikoff et al. (in instant PTO-892) which teaches that the alteration of a single amino acid in the CDR of a phosphocholine-binding myeloma protein resulting in the loss of antigen-binding function. Therefore, although Table 1 lists heavy and light chain variable region sequences of seventeen antibodies, these antibodies are not sufficient to describe the very large number of possible antibodies arising from the potential amino acid combinations encompassed by instant claim 1, as one of ordinary skill would not have expected that all such combinations would produce antibodies which bind Amyloid beta. The specification discloses antibodies for the amyloid beta specificity which comprise specific sequences for the heavy and light chain variable regions. However, as discussed above, without any way to determine how broad the genus of such antibodies are, there is no way to determine if these antibodies represent the full breadth of what is claimed. The disclosure of these specific antibodies would not convey to the artisan that Applicant was in possession of the full genus of all antibodies which possess the required functions nor does it allow the skilled artisan to envisage the specific structure of such antibodies. Instant claims 2-5 recite a list of possible CDR sequences for the HCDR1-2, LCDR1, and LCDR3. Notably, there are no sequences listed for HCDR3 and LCDR2 and as such, the instant claims do not recite a complete embodiment of the anti-amyloid beta peptide antibody. The instant claims are also claimed in a way such that the dependencies read as only requiring one CDR of the necessary six. CDRs are not generally recognized as interchangeable, such that using one CDR from one antibody would not be reasonably expected to confer the same binding properties or even the same binding target when combined with two to five CDRs from other antibodies. For example, WO 2008068048 (instant PTO-892) discloses an antibody with a heavy chain comprising three CDRs (SEQ ID NO: 2) that binds secreted aspartyl protease from Candida sp. US 20170355756 (instant PTO-892) describes the same three CDRs in the heavy chain (C10-VH3) combined with a different light chain that binds human TDP-43. There is no evidence in the instant specification that a single CDR placed in the context of two to five other CDRS, regardless of what those other CDRs are, would result in the required function, nor that a single chain is correlated to the required function when combined with any other chain. As such, the specification fails to set forth a structure-function correlation sufficient to claim all possible antibodies defined by function and one-three CDRs or alterations thereof. As such, the disclosure of seventeen antibody sequences does not convey possession of other antibodies with the same binding properties; possession of the precisely defined sequence of six CDRs is required. Instant claims 6-9 recite a sequence for the heavy and light chain variable sequences with 95% identity to a given sequence. There is no limitation or exclusion in the claim language that prevents the modifications from occurring within the CDR regions due to the claim language of having “at least 95% sequence identity”, which widens the scope of the claim to encompass an immense number of unknown molecules that share 95% identity to the claimed sequence and can bind to the claimed receptor. Additionally, the instant claims which precedes claims 6-9 have not fully defined the identity of the CDRs. As such, the sequences that are defined with 95% similarity are not adequately described as there are no specifically claimed sequences for the CDRs on which these alterations or substitutions can occur, nor is there adequate description of what the specific alterations are. Applicant has not demonstrated that they are in possession of all the molecules that fall within the immense scope of the claim that are able to achieve the claimed function. It is also noted that as written, instant claims 1-5 require that the antibody comprise only some of the recited CDR sequences. It is well established in the art that the formation of an intact antigen-binding site generally requires the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three CDRs or hypervariable regions which provide the majority of the contact residues for the binding of the antibody to its target epitope (Paul et al., in instant PTO-892), under the heading "Fv Structure and Diversity in Three Dimensions"). The amino acid sequences and conformations of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity which is characteristic of a given antibody. It is expected that all of the heavy and light chain CDRs in their proper order and in the context of framework sequences, which maintain the required conformation of the CDRs are required in order to produce a protein having antigen-binding function; and further, that proper association of heavy and light chain variable regions is required in order to form functional binding sites (Paul et al., page 293, first column, lines 3-8 and line 31 to column 2, line 9 and lines 27-30). There is no evidence in the instant specification that a single CDR placed in the context of two to five other CDRS, regardless of what those other CDRs are, would result in the required function, nor that a single chain is correlated to the required function when combined with any other chain. As such, the specification fails to set forth a structure-function correlation sufficient to claim all possible antibodies defined by function and one-three CDRs or alterations thereof. MacCallum et al. (in instant PTO-892) analyzed many different antibodies for interactions with antigen and state that although CDR3 of the heavy and light chain dominate, a number of residues outside the standard CDR definitions make antigen contacts (see page 733, right col) and non-contacting residues within the CDRs coincide with residues as important in defining canonical backbone conformations (see page 735, left col.). The fact that not just one CDR is essential for antigen binding or maintaining the conformation of the antigen binding site, is underscored by Casset et al. (in instant PTO-892) which constructed a peptide mimetic of an anti-CD4 monoclonal antibody binding site by rational design and the peptide was designed with 27 residues formed by residues from 5 CDRs (see entire document). Casset et al. also states that although CDR H3 is at the center of most if not all antigen interactions, clearly other CDRs play an important role in the recognition process (page 199, left col.). Thus, while one can make the statement that CDRs from a single antibody chain make a significant contribution in the antigen binding, the CDR domains from a single chain are not the only residues that influence binding, and in fact the prior art does not support that CDR domains from a single chain alone are sufficient to define the binding specificity of an antibody. In the instant case, the specification has not described any or all of the examples of antibodies which fit the description of the antibody recited in instant claim 1 other than those as described in the antibodies listed in Table 1. The art specifically teaches that the full complement of CDRs is required to form an intact antigen binding site, and the specification has not described which CDR sequences, other than those comprised by the antibodies of Table 1, can be paired with other CDR sequences to produce an antibody which is still capable of binding amyloid beta. To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Vas-Cath, Inc., v. Mahurkar, 935 F.2d at 1563, 19 U.S.P.Q.2d at 1116. The claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. An antibody described only by functional characteristic, such as antibody that binds amyloid beta or one of the claimed epitopes, without any known or disclosed correlation between that function and the structure of the sequence, is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the biomolecule of interest. In re Bell, 991 F.2d 781, 26 U.S.P.Q.2d 1529 (Fed. Cir. 1993). In re Deuel, 51 F.3d 1552, 34 U.S.P.Q.2d 1210 (Fed. Cir. 1995). In the instant case, the specification provides insufficient direction or guidance concerning the relationship between the structure of the possible antibody to demonstrate possession of the breadth of the genus of amyloid beta antibodies encompassed by the instant claims, especially in view of the unpredictability of such an endeavor. The prior art as evidenced by Edwards et al., 2003 (instant PTO-892) teaches there is a substantially huge antibody diversity produced to one single antigen target. Edwards provides evidence that over 1000 antibodies, all different amino acid sequences, were generated towards one single protein antigen target (see abstract). Without a correlation between structure and function, the claims do little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”). Without this guidance or direction the skilled artisan would not consider applicant to be in possession of the claimed genus of antibodies because the skilled artisan recognizes that even seemingly minor changes made without guidance or direction as to the relationship between the particular amino acid sequence of the instantly claimed antibody and its ability to bind antigen, can dramatically affect antigen-antibody binding. Applicant has not described the claimed invention sufficiently to show they had possession of the claimed genus of an antibody that binds amyloid beta. Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester v. G.D. Searle & Co., 358 F.3d 916, 69 USPQ2d 1886 (Fed. Cir. 2004). The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. What constitutes a "representative number" is an inverse function of the skill and knowledge in the art. Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. To provide adequate written description and evidence of possession of a claimed genus, the specification must provide describe a reasonable number of exemplary species of said genus, and/or provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In this case, although the specification has described seventeen anti-amyloid beta antibodies, this description is limited to specific CDR sequences. Given the very large number of possible amino acid combinations recited in instant claim 1 with respect to the CDR sequences, and the lack of requiring that all six CDRs be defined one of ordinary skill would not have viewed these seventeen antibodies as representative of the entire genus encompassed by instant claim 1. With respect to the limitations of claims 2-9, these claims do not further define the sequences/structure of the antibody of instant claim 1, and are rejected for the same reasons as discussed with respect to instant claim 1. As discussed above, the relevant art stresses the need for a full complement of 3 heavy chain CDRs and 3 light chain CDRs to form an intact antigen-binding site, and the specification does not appear to have described any antibodies which can encompasses the full scope of what is claimed. Vas-Cath Inc. v. Mahurkar , 19USPQ2d 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 they invented what is claimed.” (See Vas-Cath at page 1116). With the exception of specifically disclosed antibodies with specific CDRs, the skilled artisan cannot envision the detailed chemical structure of all of the encompassed antibodies, and 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 reference to a potential method of isolating it. The product itself is required. See Fiers v. Revel , 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd. , 18 USPQ2d 1016. One cannot describe what one has not conceived. See Fiddes v. Baird , 30 USPQ2d 1481 at 1483. In Fiddes , claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class. 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 1115). Therefore, claims 1-16 are rejected as failing to satisfy the written description requirement. 07-31-03 AIA Claim s 1-16 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 binding to amyloid beta with the antibodies of Table 1 , does not reasonably provide enablement for an antibody comprising for all the potential CDRs identities that can arise from the substitutions and variable percent identities in the instant claims and bind to amyloid beta . The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. A composition without any claimed use can be enabled for any use that would reasonably correlate with the entire scope of that claim (MPEP §2164.01(c)). In the specification, the utility of the instantly claimed antibody is to bind specifically to amyloid beta peptides. As noted above, even single amino acid mutations can lead to unpredictable changes in binding properties. While skill in the art is high, the evidence of record establishes that predictability is low. The prior art demonstrates that while one residue might tolerate a change from one amino acid to another, this does not mean that same residue can be altered to any of the 20 natural amino acids nor that a different residue of the same CDR is similarly tolerant of change, even where those substitutions are conservative. Rather, while one position might not alter functionality when being mutated, other residues might completely abrogate binding of the whole molecule if they are altered to any amino acid other than the native amino acid. This lack of predictability outweighs the minimal guidance in the specification. See the decision in Rasmusson v. SmithKline 413 F.3d 1318, 1325 (Fed. Cir. 2005) which stated: “Thus, at the end of the day, the specification, even read in the light of the knowledge of those skilled in the art, does no more than state a hypothesis and propose testing to determine the accuracy of that hypothesis. That is not sufficient. [Citation omitted.] ‘If mere plausibility were the test for enablement under §112, applicants could obtain patent rights to “inventions” consisting of little more than respectable guesses as to the likelihood of their success. When one of the guesses later proved true, the “inventor” would be rewarded the spoils instead of the party who demonstrated that the method actually worked.” In the instant case, Applicant provides seventeen antibodies via pairs of heavy and light chain variable region sequences in Table 1 of the instant specification, which include unnamed CDRs sequences that correspond to the antigen binding region. Applicant then suggests (claims) that within these CDRs, at any of the suggested positions, that the amino acids can be substituted to a select number of other amino acids. Then, those CDRs complete with any number of possible combinations arising from the substitutions can be combined with any other two to five CDRs, and still maintain a single function commensurate with every variation within the scope of the claims. Additionally, the claims are constructed in a way that does not require all six of the CDRs be present in the antibody. Without the evidence to support this claim, this remains at best a plausible hypothesis with the onus of testing placed on others with no reasonable expectation of success. This is undue experimentation as CDRs and variable chains are not generally recognized as interchangeable and if a single amino acid in one CDR can alter function, then clearly altering three of the six CDRs required for binding to any arbitrary sequence would not provide a reasonable expectation of preserving the claimed functions. Additionally, the amount of guidance or direction needed to enable an invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004). Due to the high level of unpredictability in antibody binding, the skilled artisan would need significant guidance in preparing an antibody with a targeted function. The skilled artisan recognizes that antibody binding is a wildly unpredictable endeavor that requires specificity in structure when targeting antigens. Without a proper structure provided by the Applicant for the invention(s), it is nearly impossible to envision and recognize all the potential structures amongst all potential possibilities of antibodies that would have a structure capable of binding, in addition to possessing the functionality needed to access it as a treatment. As set forth above, inadequate guidance is presented in the specification to overcome the obstacles in practicing the claimed invention in its full scope. The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue. Given the tremendous breath of scope involving the instant claims, it would require undue experimentation for one of skill in the art to practice the claimed invention in its full scope. Therefore, the specification fails to provide enough guidance for one skilled in the art on how to practice the instant method, thereby requiring trial and error experimentation to identify antibodies or recombinant proteins meeting the functional limitations of the claims. The general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is what is needed. In conclusion upon careful consideration of the Wands factors that are used to determine whether undue experimentation is required to practice an invention and the amount of direction provided by the inventor, as filed, is not deemed sufficient to enable the skilled artisan to make and/or use the invention commensurate in scope with the instant claims at the time the application was filed without undue experimentation. Therefore, claims 1-16 are not enabled for their full scope. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to SELAM BERHANE whose telephone number is (571)272-6138. The examiner can normally be reached Monday - Friday, 9-5. 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, Jeffrey Stucker can be reached at 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /SELAM BERHANE/Examiner, Art Unit 1675 /AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675 Application/Control Number: 18/258,758 Page 2 Art Unit: 1675 Application/Control Number: 18/258,758 Page 3 Art Unit: 1675 Application/Control Number: 18/258,758 Page 4 Art Unit: 1675 Application/Control Number: 18/258,758 Page 5 Art Unit: 1675 Application/Control Number: 18/258,758 Page 6 Art Unit: 1675 Application/Control Number: 18/258,758 Page 7 Art Unit: 1675 Application/Control Number: 18/258,758 Page 8 Art Unit: 1675 Application/Control Number: 18/258,758 Page 9 Art Unit: 1675 Application/Control Number: 18/258,758 Page 10 Art Unit: 1675 Application/Control Number: 18/258,758 Page 11 Art Unit: 1675 Application/Control Number: 18/258,758 Page 12 Art Unit: 1675 Application/Control Number: 18/258,758 Page 13 Art Unit: 1675 Application/Control Number: 18/258,758 Page 14 Art Unit: 1675
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