CTNF 18/629,894 CTNF 98406 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 Claims 1-12 are currently pending. Priority This application claims domestic benefit to provisional application No. 62406859, filed on 10/11/2016. The effective filing date for Claims 1-12 of the instant application is 10/10/2017. The sole independent claim, Claim 1, recites a breast cancer characterized in that it is “human epidermal growth factor receptor 2 negative” (HER2-). This limitation is not found in any of the provisional applications and first appears in the nonprovisional application 15729320, filed on 10/10/2017. Thus, the effective filing date is the same for all pending claims. Claim Rejections - 35 USC § 112(b) 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 1-12 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 regards as the invention. Claim 1 recites “lasofoxifene…or a functional derivative thereof”. There is no delimiting definition of the term derivative in the specification. It is unclear to what degree a compound may be “derived” or altered from the structure of lasofoxifene before it is no longer considered by one of skill in the art to be a derivative captured by the scope of Claim 1. Further, it is unclear whether “functional derivative” only requires some shared function between the two compounds. For example, lasofoxifene is a SERM that antagonizes estrogen receptors (ER) in breast tissue whereas a SERD serves a similar function in the same tissue. Therefore, would a SERD like fulvestrant constitute a “functional derivative” of lasofoxifene by virtue of their shared function in ER antagonism in the same tissue? For purposes of compact prosecution, “a functional derivative” of lasofoxifene is interpreted only to include lasofoxifene free base and salts thereof. Claims 2-12 are rejected by virtue of dependency. Claims 4-5 recite “wherein lasofoxifene is administered” instead of “wherein the lasofoxifene is administered”. It is unclear whether the lasofoxifene in the dependent claims are referring to the “lasofoxifene” or salts or derivatives thereof specifically recited in Claim 1. The antecedent basis should be clarified such that the wherein clause unambiguously refers only to the “effective amount of lasofoxifene” or derivatives thereof described in Claim 1. Claim Rejections - 35 USC § 112(d) 07-36 AIA The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. 07-36-01 AIA Claim 11 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 11 differs only from Claim 1, upon which 11 depends, in that the breast cancer is determined to have the particular mutation described in Claim 1. For one of skill in the art to treat the particularly mutated cancer as identified in the independent claim, the same person of skill in the art must have identified the cancer as having the claimed mutation. The determination or identification of the presence of said mutation does not alter the subgenus of cancers or patient population to be treated, nor does the identification of the cancer alter the method steps of administering lasofoxifene to the patient afflicted by the mutant cancer. Therefore, Claim 11 is not further limiting of the Claim upon which it depends . Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claim 12 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not clearly fall within at least one of the four categories of patent eligible subject matter because the claim recites the limitation of “determining that the cancer has a missense mutation”. This step is a judicial exception because it is an abstract idea insofar that it amounts to a mental process, wherein the nonmutant cancers are untreated. Per MPEP 2106.04(a)(2), III., “The courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). As the Federal Circuit explained, "methods which can be performed mentally, or which are the equivalent of human mental work, are unpatentable abstract ideas–the ‘basic tools of scientific and technological work’ that are open to all.’" 654 F.3d at 1371, 99 USPQ2d at 1694 (citing Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972)).” In the case where patients are not determined “to have a missense mutation in the ESR1 gene” as claimed, this judicial exception is not integrated into a practical application because it amounts to nothing more than interpreting data for the patient subpopulation that is not determined “to have a missense mutation”. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because no process is positively recited as to how the invention is to be used in the case of the subpopulation of cancer wherein no such mutation is identified. 07-06 AIA 15-10-15 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim s 1-3 and 6-12 are rejected under 35 U.S.C. 103 as being unpatentable over Hattersley (WO2016176666) . Hattersley teaches the treatment of ER+/HER2- advanced or metastatic breast cancer with SERDs (RAD 1901 and fulvestrant) and that combinations with CDK4/6 inhibitors including abemaciclib are under development (Para 10; Claims 1-4, 19, and 35). CDK4/6 and SERM combination therapy is also discussed (Para 10). Lasofoxifene is described as a SERM (Para 4). Particular mutant cancers to be treated are discussed, including those claimed like E380Q or Y537S (Paras 90, 115; Claims 5-6). Hattersley does not preclude “locally advanced” tumors from the category of “advanced or metastatic” and also describes tumor growth to be treated as “localized” to a “tumor or to a set of tumors within specific tissues or organs”; i.e., locally advanced (Para 87). Regarding Claims 11 and 12, the determination of the ESR1 mutant status is required to identify and treat the diseases described in Hattersley. One of skill in the art would therefore find it obvious to screen for the mutations described in Hattersley to achieve appropriate treatment before the effective filing date of the examined invention. One of skill in the art seeking to treat the particular breast cancers described in Hattersley would find it obvious to attempt said treatment with the combination of CDK4/6 inhibitors (abemaciclib) and SERMs (lasofoxifene) identified as being under development for treatment of the same disease before the effective filing date of the examined claims because Hattersley offers the combination as a potential therapeutic. One of skill in the art would expect success in doing so because the therapeutics are taught or suggested for treatment of the same or similar variants of breast cancer alone or in combination. Further, SERMs and SERDs do both target ER which is taught to be positive or overexpressed in the breast cancer variant claimed and taught in Hattersley . 07-21-aia AIA Claim s 1-4 and 6-12 are rejected under 35 U.S.C. 103 as being unpatentable over Hattersley as applied to Claims 1-3 and 6-12 in further view of LaCroix ( JNCI: Journal of the National Cancer Institute , Volume 102, Issue 22, 17 November 2010, Pages 1706–1715) and Wardell (Mol Endocrinol, July 2012, 26(7):1235–1248) . The teachings of Hattersley are set forth above and incorporated by reference herein. Hattersley is silent as to a particular salt form of lasofoxifene. LaCroix teaches the use of 0.5mg lasofoxifene to reduce ER+ breast cancer incidence, not precluding HER2 status (Abstract; Page 1709, Right Col.). SERMs like lasofoxifene are also reported to prevent and treat osteoporosis; “Preclinical laboratory evidence showed that lasofoxifene reduced bone loss and cholesterol, prevented experimental breast cancers, and did not cause endometrial hyperplasia” (Page 1707, Left Col.). LaCroix cites FDA data evaluating lasofoxifene tartrate specifically (Page 1707, Left Col., ( 20 ); Page 1714, 20. Pfizer Inc. FABLYN ® (lasofoxifene tartrate)… ). Wardell specifically compares the activity of SERMs and SERDs. Tamoxifen and raloxifene, two SERMs, were “developed as a treatment for ER positive breast cancer…[and] exhibited agonist activity in the bone…[with] potential utility in the treatment/prevention of osteoporosis” whereas SERDs are “full ER antagonist[s] ” (Pages 1236-37), having the opposite effect of SERMs in bone tissue, for example, despite similar activity in breast tissue. Hattersley, with respect to osteoporosis, teaches the risk of SERD therapy with fulvestrant; “Patients treated with fulvestrant may also be exposed to the risk of osteoporosis due to its mechanism of action” (Para 8). Therefore, one of skill in the art, before the effective filing date of the examined claims, seeking to treat the particular breast cancer variant described in Hattersley would find it obvious to modify the methods taught by and within the therapeutic confines of Hattersley to instead use lasofoxifene, a SERM, over RAD 1901 or fulvestrant, two SERDs, to reduce osteoporotic risk to older or susceptible patients because Wardell teaches osteoporotic treatment/prevention with SERMs. One of skill in the art would expect success in doing so, especially with the tartrate salt of fulvestrant which is taught for clinical use by LaCroix in the treatment of ER+ breast cancer, because both SERMs and SERDs are antagonistic in breast tissues, where the cancer is present, whereas SERMs are taught to pose less of a risk and instead even prevent osteoporosis (by virtue of its contrasting activity in off-target sites), a complication known to be associated with SERD activity. Regarding unrejected Claim 5, lasofoxifene is reported in LaCroix to treat ER+ breast cancer in doses of 0.5mg and NOT 5mg as claimed (Abstract). The art does not teach increasing the standard dose to time ten times what is taught in LaCroix to reach the claimed dosage of 5mg. Therefore, Claim 5 is not rejected over the cited art . Double Patenting 08-30 AIA A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co. , 151 U.S. 186 (1894); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert , 245 F.2d 467, 114 USPQ 330 (CCPA 1957). A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101. 08-32 AIA Claim s 1-12 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of Claim s 1-12 of copending Application No. 18628664 . This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented. 08-33 AIA The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action . Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. NONPROVISIONAL : 1. Claims 1-12 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-17 of U.S. Patent No. 10258604 (hereinafter referred to as Duke) in view of Hattersley (WO2016176666). Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating locally advanced or metastatic ER+ breast cancers with the same ESR1 mutations comprising administering 5mg lasofoxifene tartrate with a CDK4/6 inhibitor. Duke is silent as to the HER2 status of the cancer and does not teach a particular CDK4/6 inhibitor. Hattersley teaches ER+/HER2- breast cancer is reportedly treated with CDK4/6 inhibitor palbociclib in combination with breast tissue ER antagonist fulvestrant, a SERD. Hattersley further teaches CDK4/6-SERM combinations are also under development as treatments (Para 10). Abemaciclib is taught as a CDK inhibitor and lasofoxifene, as claimed in Duke, is taught as a SERM, similarly targeting breast cancer ER (Para 4 and 10). One of skill in the art seeking to treat the narrower HER2- subvariant of breast cancer would find it obvious to do so with the Duke method, substituting the SERD for a SERM, while selecting abemaciclib as the CDK4/6 inhibitor because Hattersley teaches such agents as acceptable therapeutics for treating the same disease. One of skill in the art would expect success in doing so because both SERMs and SERDs target breast ER. Regarding Claims 11 and 12, the determination of the ESR1 mutant status is required to identify and treat the diseases described in Duke. One of skill in the art would therefore find it obvious to screen for the mutations described in Duke to achieve appropriate treatment for the method describing said mutations. Since both claim sets teach treating ER+ breast cancer with lasofoxifene, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Duke. 2. Claims 1-12 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-19 of U.S. Patent No. 10905659 (hereinafter referred to as Duke) in view of Hattersley (WO2016176666). Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating locally advanced or metastatic ER+/HER- breast cancers with the same ESR1 mutations comprising administering 5mg lasofoxifene tartrate with a CDK4/6 inhibitor. Duke does not teach a particular CDK4/6 inhibitor. Hattersley teaches ER+/HER2- breast cancer is reportedly treated with CDK4/6 inhibitor palbociclib in combination with breast tissue ER antagonist fulvestrant, a SERD. Hattersley further teaches CDK4/6-SERM combinations are also under development as treatments (Para 10). Abemaciclib is taught as a CDK inhibitor and lasofoxifene, as claimed in Duke, is taught as a SERM, similarly targeting breast cancer ER (Para 4 and 10). One of skill in the art seeking to treat the same subvariant of breast cancer would find it obvious to do so with the Duke method, selecting abemaciclib as the CDK4/6 inhibitor, because Hattersley teaches it as an acceptable inhibitor for treating the same disease in conjunction with a SERM. One of skill in the art would expect success in doing so because abemaciclib is a CDK4/6 inhibitor for treating breast cancer. Regarding Claims 11 and 12, the determination of the ESR1 mutant status is required to identify and treat the diseases described in Duke. One of skill in the art would therefore find it obvious to screen for the mutations described in Duke to achieve appropriate treatment for the method describing said mutations. Since both claim sets teach treating ER+/HER2- breast cancer with lasofoxifene, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Duke. 3. Claims 1-2 and 4-12 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-32 of U.S. Patent No. 11497730 (hereinafter referred to as Duke). Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating metastatic ER+/HER- breast cancer with the same ESR1 mutations comprising administering 5mg lasofoxifene tartrate with abemaciclib, a CDK4/6 inhibitor. Regarding Claims 11 and 12, the determination of the ESR1 mutant status is required to identify and treat the diseases described in Duke. One of skill in the art would therefore find it obvious to screen for the mutations described in Duke to achieve appropriate treatment for the method describing said mutations. Since both claim sets teach treating metastatic ER+/HER2- breast cancer comprising administering the same therapeutics, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Duke. 4. Claims 1-2 and 4-12 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-27 of U.S. Patent No. 11974983 (hereinafter referred to as Duke). Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating metastatic ER+/HER- breast cancer with the same ESR1 mutations comprising administering 5mg lasofoxifene tartrate with abemaciclib, a CDK4/6 inhibitor. Regarding Claims 11 and 12, the determination of the ESR1 mutant status is required to identify and treat the diseases described in Duke. One of skill in the art would therefore find it obvious to screen for the mutations described in Duke to achieve appropriate treatment for the method describing said mutations. Since both claim sets teach treating metastatic ER+/HER2- breast cancer comprising administering the same therapeutics, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Duke. 5. Claims 1-12 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-9 of U.S. Patent No. 11980597 (hereinafter referred to as Duke). Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating locally advanced or metastatic ER+/HER- breast cancer with the same ESR1 mutations comprising administering 5mg lasofoxifene tartrate with abemaciclib, a CDK4/6 inhibitor. Regarding Claims 11 and 12, the determination of the ESR1 mutant status is required to identify and treat the diseases described in Duke. One of skill in the art would therefore find it obvious to screen for the mutations described in Duke to achieve appropriate treatment for the method describing said mutations. Since both claim sets teach treating metastatic ER+/HER2- breast cancer comprising administering the same therapeutics, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Duke. 6. Claims 1-12 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-19 of U.S. Patent No. 12414924 (hereinafter referred to as Duke). Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating ER+/HER- breast cancer with the same ESR1 mutations comprising administering 5mg lasofoxifene tartrate with abemaciclib, a CDK4/6 inhibitor. Regarding Claims 2-3, Duke teaches the treatment is sufficient to reduce progression of the breast cancer. Duke does not particularly describe progression as locally advanced or metastatic; however, progression necessarily entails local growth or spreading or some metastasis beyond the local tissues. Therefore, the prevention or reduction of progression is tantamount to treating locally progressed or metastatic cancer. Regarding Claims 11 and 12, the determination of the ESR1 mutant status is required to identify and treat the diseases described in Duke. One of skill in the art would therefore find it obvious to screen for the mutations described in Duke to achieve appropriate treatment for the method describing said mutations. Since both claim sets teach treating metastatic ER+/HER2- breast cancer comprising administering the same therapeutics, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Duke. Conclusion No claim is allowable. Inquiries Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 8:30am - 4:30pm EST. 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. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /RICHARD GRANT PECKHAM/Examiner, Art Unit 1627 Application/Control Number: 18/629,894 Page 2 Art Unit: 1627 Application/Control Number: 18/629,894 Page 3 Art Unit: 1627 Application/Control Number: 18/629,894 Page 4 Art Unit: 1627 Application/Control Number: 18/629,894 Page 5 Art Unit: 1627 Application/Control Number: 18/629,894 Page 6 Art Unit: 1627 Application/Control Number: 18/629,894 Page 7 Art Unit: 1627 Application/Control Number: 18/629,894 Page 8 Art Unit: 1627 Application/Control Number: 18/629,894 Page 9 Art Unit: 1627 Application/Control Number: 18/629,894 Page 10 Art Unit: 1627 Application/Control Number: 18/629,894 Page 11 Art Unit: 1627 Application/Control Number: 18/629,894 Page 12 Art Unit: 1627 Application/Control Number: 18/629,894 Page 13 Art Unit: 1627 Application/Control Number: 18/629,894 Page 14 Art Unit: 1627 Application/Control Number: 18/629,894 Page 15 Art Unit: 1627 Application/Control Number: 18/629,894 Page 16 Art Unit: 1627 Application/Control Number: 18/629,894 Page 17 Art Unit: 1627