CTNF 18/595,057 CTNF 81471 DETAILED ACTION 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. Claims 1-22 are pending. An action on the merits is set forth below. 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. Specification 07-29-04 The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. see page 32 Claim Objections 07-29-01 AIA Claim 8 is objected to because of the following informalities: the Claim requires “lung,.” however the claim should be modified to “lung.” . Appropriate correction is required. Claim Rejections - 35 USC § 112 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. 07-31-03 AIA Claim s 1-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, because the specification, while being enabling for detection of the presence or absence of SPINK1 , does not reasonably provide enablement for correlation of any presence or absence of SPINK1 to diagnosis, predisposing of any acute or chronic lung disease 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 or use the invention commensurate in scope with these claims. Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, have been described by the court in In re Wands , 8 USPQ2d 1400 (CA FC 1988). Wands states at page 1404 , “Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.” Breadth of the claims The claims are drawn to method for identifying a subject at risk for developing, risk of rapid progression, and/or diagnosing predisposition to acute or chronic lung disease by measuring the presence or absent of SPINK1. The specification does not provide any examples or guidance of correlation of the presence or absence of SPINK1 in any sample in any subject. Further, the art teaches that such associations are unpredictable. When the claims are read in light of the specification, the specification discloses a general methodology of assessing presence of SPINK1, but does not provide any correlative associations between any presence or absence of SPINK1 and any diagnosis or risk of any chronic lung disease. Accordingly, the specification cannot be relied upon for providing support or enablement for the breadth of the method. Nature of the Invention The invention is in a class of invention which the CAFC has characterized as “the unpredictable arts such as chemistry and biology.” Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001). Teachings in the Specification The specification teaches that SPINK is expressed in pancreases, stomach, liver and bladder but not in the lung (p. 18). The specification suggests that there is an expression in chronic lung disease (p. 20-22). Therefore the specification teaches expression levels but does not provide guidance for absence of SPINK1 but rather expression. The specification does not provide any guidance that detection of presence or absence of SPINK1 provides diagnosis or progression of any lung disease. Further, the specification has not provided any guidance of improvement of quality of life. Further, as discussed below, such correlation are population and disease specific and require undue experimentation. The predictability or unpredictability of the art and degree of experimentation Further the claims are drawn to any sample type. The art of Cobb et al (Crit Care Med 2002 Vol. 30 p. 2711) teaches the unpredictability in analysis of gene expression in spleen and liver sample from septic mice. Notably, the reference teaches that, when compared to a non-septic sample, the relevant expression profiles of the septic mouse spleen and the septic mouse liver contain different nucleic acids at different levels (Table 1; p.2714, middle col., lns.2-8). As such the art teaches that expression levels of the same nucleic acids in different tissue samples differ. Therefore the art indicates that an association of expression level to a disease in one sample would not be correlative to an association to any other sample type. Therefore the art suggests the unpredictability of associating expression levels in one sample (such as a bone marrow) and other samples (such as a liver biopsy). Enard et al. (Science 2002 Vol 296 p. 340) teaches that even between closely related species gene expression patterns differ (abstract). Enard et al. teaches that mRNA expression levels are different between humans, chimpanzees, orangutans and rhesus marcques (p. 340 1st column last sentence-2nd column 1st paragraph). Enard et al. teaches that there are a large number of quantitative differences in gene expression in closely related mammals (p. 342 2nd column last paragraph). Shalon et al. (US 2001/0051344 A1 Dec 13, 2001) teach that due to variations in genetic make-up of unrelated individuals in a heterogeneous society, differences in the expression of a gene between any two individuals may or may not be significant (see page 10, paragraph 0155). Shalon et al. further teach that the larger the number of individuals tested, the more significant the remaining differences in gene expression become and samples from at least 5 and preferably 20-50 different test individuals are assayed to obtain statistically meaningful data showing a statistical elevation or reduction in report levels when compared to control levels (see page 10, paragraph 0156). Shalon et al. teach that the test average pattern is compared with a control average pattern on a microarray to identify test genes which show significantly, typically at least 2 fold and up to 100 fold or more, increase or decrease in gene expression level with respect to control levels for the same gene (see page 10, paragraph 0158). Lucentini (The Scientist, 2004, Vol 18, page 20) teach that it strikingly common for follow-up studies to find gene-disease associations wrong (see page 2, 1 st paragraph). Lucentini teaches that two recent studies found that typically when a finding is first published linking a given gene to a complex disease there is only roughly a one-third chance that the study will reliably confirm the finding (see page 2, 3 rd paragraph). Lucentini teaches that bigger sample sizes and more family-based studies, along with revising statistical method, should be included in the gene association studies (see page 3, 2 nd paragraph). The art teach associations need to be confirmed by multiple large sampling sizes to determine a clear association. The art teaches that associations are population based and that it is difficult to reproduce expression studies. The art teaches that correlation between disease conditions and genetic expression is often irreproducible. Therefore the skilled artisan would have to perform undue experimentation in order to diagnosis any patient in any sample increase or decrease saccharate expression and progression of any disease. Quantity of Experimentation The quantity of experimentation in this area is extremely large since there are a significant number of parameters, which would have to be studied prior to being able to practice the claimed invention as broadly as written. The skilled artisan would have to determine the correlation of expression in any sample in any species. The skilled artisan would have to determine the association of either increased or decreased expression or presence and absence of SPINK1 with an extremely large number of complex disorders. This would require significant inventive effort, with each of the many intervening steps, upon effective reduction to practice, not providing any guarantee of success in the succeeding steps. Level of Skill in the Art The level of skill in the art is deemed to be high . Conclusion Case law has established that '(t)o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without 'undue experimentation.'" In re Wright 990 F.2d 1557, 1561. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) it was determined that '(t)he scope of the claims must bear a reasonable correlation to the scope of enablement provided by the specification to persons of ordinary skill in the art". The amount of guidance needed to enable the invention is related to the amount of knowledge in the art as well as the predictability in the art. Furthermore, the Court in Genetech Inc. v Novo Nordisk 42 USPQ2d 1001 held that '(I)t is the specification, not the knowledge of one skilled in the art that must supply the novel aspects of the invention in order to constitute adequate enablement". In the instant case, the specification does not provide any examples or guidance to correlate increased or decreased expression, presence or absence of SPINK1 any sample from any species with diagnosis, predisposing of any acute or chronic lung diseases and improvement. Further the art teaches that association studies are often irreproducible and that the associations are population specific. In view of this unpredictability, the specification has not established that the presently claimed method can be used to predict progression of any disease. Accordingly, in view of the unpredictability in the art, and the lack of disclosure in the specification and in the prior art and the unpredictability of the art, it would require undue experimentation for one of skill in the art to make and use the claimed invention. 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 1-22 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. Claims 1, 4-21 are indefinite over “detecting the presence or absence of the SPINK1” in step b of claim 1. In particular the claims drawn drawn to “detecting the presence of absence of the SPINK1 which could encompass numerous interpretations including activity, expression, protein level. However, step a teaches a biological sample comprising genomic DNA. As such it is not clear how to perform step b in view of the sample of a as it only requires genomic DNA. Therefore the metes and bounds are unclear. Claim 2 is unclear over step b. In particular it is not clear the metes and bounds of “the presence or absence”. It is not clear if the claims are refereeing to the presence of the gene, expression of the gene or protein activity. Therefore the metes and bounds are unclear. Claim 3 is unclear over step b. In particular it is not clear the metes and bounds of “the presence or absence”. It is not clear if the claims are refereeing to the presence of the gene, expression of the gene or protein activity. Therefore the metes and bounds are unclear. Claim 5 is indefinite. In particular claim 1 requires detection of presence or absence of SPINK1. Therefore it is not clear if the claim intends to perform a prediction of biological sample of claim 5 as the claim requires a predetermination of the presence of the gene. Claim 22 is unclear over step b. In particular it is not clear the metes and bounds of “the presence or absence”. It is not clear if the claims are refereeing to the presence of the gene, expression of the gene or protein activity. Therefore the metes and bounds are unclear. Claim 11 and 18 indefinite over “improving the subject”. The term is a relative term which renders the claim indefinite. The term “improving” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear which quality and/or extending would be encompassed by the term “improving”. Claim 14 is indefinite as it is not clear what is measured, the sample or particular cells from the sample. Further it is not clear how the step alters the preamble of detecting the presence or absence of SPINK1. 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. CLiams 2-3, 10-11, 22 32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural correlation without significantly more. The claim(s) recite(s) a judicial exception of correlation risk or development or diagnosis and SPINK1 presence or absence. This judicial exception is not integrated into a practical application because the claims require steps measuring expression of naturally known genes and does not provide a step to integrate the judicial exception. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not integrate the judicial exception to steps that are not considered routine and conventional steps. These judicial exceptions are not integrated into a practical application because the claims only recite the natural correlation, wherein the step of obtaining a sample and detecting SPINK1 presence and absence does not integrate the judicial expectation. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps are considered general and routine knowledge in the prior art as exemplified by the specification (as discussed below). According to the 2019 Patent Eligibility Guidance an initial two step analysis is required for determining statutory eligibility. Step 1. Is the claim directed to a process, machine, manufacture, or composition of matter? In the instant case the Step 1 requirement is satisfied as the claims are directed towards a process. Step 2A Prong one. Does the claim recite a law of nature, a natural phenomenon or an abstract idea? Yes, a natural phenomenon The correlation of the phenotypes and the presence or absence of SPINK1 is considered a natural correlation. Step 2A prong two. Does the claim recite additional elements that integrate the judicial exception into a practical application? The answer is no as the steps require only routine and convention steps and does not integrate the judicial exception to a practical application. Step 2B. Does the claim recite additional elements that are significantly more than the judicial exceptions? No as the claims do not require any elements that integrate the judicial exception. The steps that are not considered judicial expectations are the steps of obtaining a sample and detecting presence or absence of SPINK1. Sedlak et al. (WO 2022/011197 January 13, 2022) teaches a method of obtaining a sample from a patient with lung disease and detecting SPINK1 (para 10). Claim Rejections - 35 USC § 102 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. 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 07-15-aia AIA Claim(s) 1-11, 15-19 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Sedlak et al. (WO 2022/011197 January 13, 2022) . With regard to claim 1, Sedlak et al. teaches a method of obtaining a sample from a patient with lung disease and detecting SPINK1 (para 10). With regard to claims 2-3, Sedlak et al. teaches a method of obtaining a sample from a patient with lung disease and detecting SPINK1 (para 10).With regard to the wherein clause, it is interpreted as the intended result of the detecting step. As with regard to claim 1, Sedlak et al. teaches the required steps, the teaching of Sedlak et al. is capable of the intended wherein clause. With regard to claim 4, Sedlak et al teaches that the subject can be suspected of having lung disease (para 9). With regard to claim 5, Sedlak et al. teaches that the sample has SPINK1 (para 10). With regard to claim 6, Sedlak et al. teaches that the sample has elevated levels of SPINK1 compared to healthy samples (para 10 and 82-97). With regard to claims 7-8, Sedlak et al teaches that the sample is blood derived sample that comprises lung cells (para 9). With regard to claim 9, Sedlak et al. teaches sequencing (para 157). With regard to claim 10 and 11, it is interpreted as the intended result of the detecting step. As with regard to claim 1, Sedlak et al. teaches the required steps, the teaching of Sedlak et al. is capable of the intended wherein clause. Wither regard to claim 15, Sedlak et al. teaches administering treatment for lung cancer (para 6). With regard to claims 16-17, Sedlak et al. teaches administering before and after onset (31-36). With regard to claims 18-19, as Sedlak et al. teaches treating and this treatment would be considered to reduce the need for additional interventions as it would be treating the disease . Claim Rejections - 35 USC § 103 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. 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. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA Claim (s) 12-13, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sedlak et al. (WO 2022/011197 January 13, 2022) in view of Rajagopal et al. (US Patent Application 2021/0040442 Feb 11, 2021) .. With regard to claim 21, Sedlak et al. teaches a method of obtaining a sample from a patient with lung disease and detecting SPINK1 (para 10).With regard to the wherein clause, it is interpreted as the intended result of the detecting step. As with regard to claim 1, Sedlak et al. teaches the required steps, the teaching of Sedlak et al. is capable of the intended wherein clause. However, Sedlak et al. teaches not teach that the disease is asthma or club cells. With regard to claim 12, Rajagopal et al. that SPINK1 is associated with other lung disease types includes asthma (table 15 and para 75). With regard to claims 22, 13, , Rajagopal et al. teaches a method using club cells (para 76). Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the method of Sedlak et al. to further screen the sample for known lung diseases including those taught by Rajagopal et al. The ordinary artisan would be motivated as Rajagopal et al. teaches that SPINK1 is associated with other diseases such as asthma . 07-21-aia AIA Claim (s) 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sedlak et al. (WO 2022/011197 January 13, 2022) . Sedlak et al. teaches a method of obtaining a sample from a patient with lung disease and detecting SPINK1 (para 10).With regard to the wherein clause, it is interpreted as the intended result of the detecting step. As with regard to claim 1, Sedlak et al. teaches the required steps, the teaching of Sedlak et al. is capable of the intended wherein clause. However, Sedlak et al. teaches not teach measurement of collagen . With regard to claims 20-21, Sedlak et al. teaches administering treatment for lung cancer (para 6). Sedlak et al. teaches administering before and after onset (31-36). Sedlak et al. teaches and as such the treatment would be considered to reduce the need for additional interventions as it would be treating the disease. Although Sedlak et al. teaches not teach that the disease is slowed and detected by clinical evaluation, it would be obvious to one of to one of ordinary skill int eh art at the time of the effective filing date so that the treatment of Sedlak et al. is measured to determine efficiently using known methods. The ordinary artisan would have a reasonable expectation of success as Sedlak et al. teaches treatment of routine treatments for lung cancer . Double Patenting 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. 08-35 Claim s 1-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-5, 7-18 of copending Application No. 18595079 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to detection the presence of SPINK1 and associations of lung disease . This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530. 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, Wu Cheng (Winston) Shen can be reached at 5712723157. 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. /KATHERINE D SALMON/ Primary Examiner, Art Unit 1682 Application/Control Number: 18/595,057 Page 2 Art Unit: 1682 Application/Control Number: 18/595,057 Page 3 Art Unit: 1682 Application/Control Number: 18/595,057 Page 4 Art Unit: 1682 Application/Control Number: 18/595,057 Page 5 Art Unit: 1682 Application/Control Number: 18/595,057 Page 6 Art Unit: 1682 Application/Control Number: 18/595,057 Page 7 Art Unit: 1682 Application/Control Number: 18/595,057 Page 8 Art Unit: 1682 Application/Control Number: 18/595,057 Page 9 Art Unit: 1682 Application/Control Number: 18/595,057 Page 10 Art Unit: 1682 Application/Control Number: 18/595,057 Page 11 Art Unit: 1682 Application/Control Number: 18/595,057 Page 12 Art Unit: 1682 Application/Control Number: 18/595,057 Page 13 Art Unit: 1682 Application/Control Number: 18/595,057 Page 14 Art Unit: 1682 Application/Control Number: 18/595,057 Page 15 Art Unit: 1682 Application/Control Number: 18/595,057 Page 16 Art Unit: 1682 Application/Control Number: 18/595,057 Page 17 Art Unit: 1682 Application/Control Number: 18/595,057 Page 18 Art Unit: 1682 Application/Control Number: 18/595,057 Page 19 Art Unit: 1682
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