DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Objections Claim 7 is objected to because of the following informalities: unclear language in the claim. The claim recites “wherein is the sliding member” appears to be a typographical error. Appropriate correction is required. Claim Rejections - 35 USC § 10 2 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 – (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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claim s 1 -6, 8 and 9 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by McCaffrey et al. ( US Pub. 20190091417 ). With regards to claim 1, McCaffrey et al. discloses a transcutaneous insertion device (100) , comprising: a sliding member (104 / 106) coupled to an insertion member ( 116 ) , wherein the insertion member is a drug delivery cannula (needle, see para 0028) or a blood glucose sensing probe (see fig. 1,8) , and is operable to penetrate a surface of skin; a drive mechanism coupled to a linkage (110/112/114) , wherein the linkage (114) is operable to advance the sliding member (the linkage with the springs) ; and a stop beam (126) , wherein, when the sliding member is acted upon by the drive mechanism via the linkage (the springs and linkage element control the movement of the sliding member 106, see para. 0045-0054) , the stop beam is operable to facilitate over-travel of the sliding member past the stop beam (see movement of the slide member from fig. 8 - fig. 12 , specifically fig. 9 ) and allow the sliding member to retract until lodged against the stop beam (see fig. 12) to thereby cause the insertion member to retract from a first insertion position to a second insertion position (fig. 9 to fig. 12) . With regards to claim 2, McCaffrey et al. teaches a device the is configured to create a cavity beyond a distal tip of the insertion member beneath the surface of the skin based on the insertion and retraction of the device (how the device is being used). Furthermore, the device would meet the intended use of the claim based on the claimed structure recited in the claim and the teaching in the prior art reference , for example the spring force would create a forward pressure during insertion and when the force is removed the insertion member would retract thus creating a cavity. With regards to claims 3, 4, McCaffrey et al. teaches the drive mechanism further comprises , a drive force element (springs, 110/112) that acts on the linkage to advance the sliding member toward the stop beam. With regards to claim 5, McCaffrey et al. teaches the sliding member further comprises , a sliding member recess operable to capture the stop beam and limit movement of the sliding member to allow the over-travel of the sliding member (lower portion recess of the sliding member that captures the lower portion of the stop beam, as illustrated in fig. 12), with regards to claim 6, McCaffrey et al. teaches a guide configured to direct the sliding member toward the stop beam (the housing component, 102). With regards to claim 8, McCaffrey et al. teaches the insertion member is coupled to a fluid pathway from a reservoir (see para. 0030, 0034, 0070) . With regards to claim 9, McCaffrey et al. teaches the drive mechanism is actuated by a manual mechanism (para. 0038). Claim Rejections - 35 USC § 103 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. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. Claims 1- 16, 19, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Schmid (US Pub. 2016/0361013) , and further in view of Yodfat et al. (US Pub. 2012/0259185) and Skutnik et al. (US 9,782,536) . With regards to claims 1 , Schmid teaches transcutaneous insertion device (fig. 1, 180/280) , comprising: a sliding member coupled to an insertion member (284/286) , wherein the insertion member is a drug delivery cannula or a blood glucose sensing probe (para. 0067-0072) , and is operable to penetrate a surface of skin; a drive mechanism coupled to a linkage (282, 283a, 283b, para. 0067-0072) , wherein the linkage is operable to advance the sliding member ( para. 0067-00 72) ; and a stop beam (latches extending from the top of the frame – para. 0072) , wherein, when the sliding member is acted upon by the drive mechanism via the linkage, the stop beam is operable to facilitate over-travel of the sliding member past the stop beam (sliding over the latches) While Schmid teaches and illustrates in figure 5 a recess that engages a latch 187 , Schmid fails to explicitly state the sliding member is configured to retract until lodged against the stop beam to thereby cause the insertion member to retract from a first insertion position to a second insertion position. Yodfat et al. discloses an infusion device that includes an insertion member that is adjustable (see fig. 7a-20b, para. 0019-0024, 0048, ) in order to vary the depth of the insertion member/cannula. Yodfat teaches multiple embodiments that illustrate a stop element (stop beam) that engage a flange structure in order to control the movement of the insertion member in both a forward and backward direction that vary the spacing and size of the engaged portions (for example, see figs, 13a-14b, para. 0069-0072 as well as in fig. 16a-18b, para. 0074-0077). Skutnik et al. teaches the level of skill in the art and the benefit of retracting the position of the needle/cannula in a patient by adjusting the depth of the needle/cannula in order to reduce irritation of the subcutaneous layer (see Skutnik, col. 22, ll. 5-57, and fig. 14). I t would have been obvious to person of ordinary skill in the art before the effective filing to modify the device of Schmid with the teachings of Yodfat et al. and Skutnik et al. to have the sliding member be configured to retract until lodged against the stop beam (flanges on the top surface of the frame) to thereby cause the insertion member to retract from a first insertion position to a second insertion position because Yodfat et al. , teaches different mechanisms that engage sliding member with an insertion member so that the depth level can be adjust ed and allow the member to move in both a forward and backward direction. Additionally, Skutnik et al. teaches the benefit for retracting an insertion member/(cannula/needle) after insertion so that tissue trauma can be reduced. Specifically, one of ordinary skill in the art would understand and only use routine skill to modify the sliding member of Schmid (as pictured in fig. 3, 5, 9, 10) to include a receiving structure such as a recess and a groove (already taught in fig. 5 of Schmid) in order to catch the stop beam ( latch ) of the frame because the prior art (Yodfat et al.) teaches latches/flanges/protrusions of the insertion member engaging with grooves of the housing as a commonly used engagement mechanism and allowing additional space and movement provide the benefit of retracting the insertion member as well as adjust the depth of the insertion member. Therefore, it would have been obvious to modify the spacing of the recess and engagement of the stop beam and recess, in order to allow the sliding member to retract to a second position because of the benefit of reducing trauma and irritation of the patient as taught by the prior art . With regards to claim 2, the combined device would perform the intended use when the sliding member is retracted to a second position, thus creating a cavity beyond a distal tip of the insertion member beneath the surface of the skin. With regards to claims 3, 4, Schmid teaches the drive mechanism further comprises a drive force such as a spring element that acts on the linkage to advance the sliding member toward the stop beam ( 181/281 ) . With regards to claim 5, the combined device of Schmid , Yodfat et al. , and Skutnik et al. teaches the sliding member including a sliding recess operable to capture the stop beam and limit movement of the sliding member to allow the overtravel of the sliding member as modified in claim 1 above. Therefore, it would have been obvious to include a sliding recess operable to capture the stop beam and limit movement of the sliding member to allow the overtravel of the sliding member because Schmid teaches a recess that captures a stop beam (along with the modification made in claim 1) thus making the modification an obvious modification to one ordinary skill in the art. With regards to claim 6 , the combined device of Schmid , Yodfat et al., and Skutnik et al. , teaches a guide (290 as taught by Schmid ) configured to direct the sliding member toward the stop beam. With regards to claim 7 , the combined device of Schmid , Yodfat et al., and Skutnik et al. teaches the sliding member further comprises a first sliding member (186/286 as taught by Schmid ) coupled to the insertion member; and a second sliding member (184/284 as taught by Schmid ) coupled to the linkage (283a,b as taught by Schmid ) , wherein the first sliding member is configured with a sliding member recess operable to capture the stop beam and limit movement of the sliding member to allow the overtravel of the first sliding member (as modified by in claim 1 above) . With regards to claim 8 , the combined device of Schmid , Yodfat et al., and Skutnik et al. teaches the insertion member is coupled to a fluid pathway from a reservoir (para. 0064-0066, as taught by Schmid) . With regards to claim 9 , the combined device of Schmid , Yodfat et al., and Skutnik et al. teaches the drive mechanism is actuated by a manual mechanism, an electronic circuit or a combination of both (para. 0087 as taught by Schmid) . With regards to claim 10, Schmid teaches transcutaneous insertion device (fig. 1, 180/280), comprising: a sliding member coupled to an insertion member ( 148/186; 284/286) wherein the insertion member is operable to penetrate a surface of skin (para. 0067-0072) ; a drive mechanism coupled to a linkage ( 182, 183a, 183b or 282, 283a, 283b, para. 0067-0072) , wherein in a first state, the sliding member and the linkage coupled to the drive mechanism have over-traveled a stop beam ( latches extending from the top of the frame – para. 0072 , slides over the latches [moving from fig. 1 to fig. 3/ 5 Schmid teaches and illustrates in figure 5 a recess that engages a latch 187 ] alternatively, moving from fig. 7 to fig. 8 ) , and in a second state, the sliding member is lodged against the stop beam ( Schmid fig. 5 ) , wherein the linkage (183a/183b) is returned to an initial position in the second state ( Schmid fig. 5 ) . Schmid fails to explicitly discloses in a first state, movement of the insertion member creating of a cavity beyond a distal tip of the insertion member beneath the surface of the skin and the sliding member is lodged against the stop beam after being retracted by the linkage . Yodfat et al. discloses an infusion device that includes an insertion member that is adjustable (see fig. 7a-20b, para. 0019-0024, 0048) in order to vary the depth of the insertion member/cannula. Yodfat teaches multiple embodiments that illustrate a stop element (stop beam) that engage a flange structure in order to control the movement of the insertion member in both a forward and backward direction that vary the spacing and size of the engaged portions (for example, see figs, 13a-14b, para. 0069-0072 as well as in fig. 16a-18b, para. 0074-0077). Skutnik et al. teaches the level of skill in the art and the benefit of retracting the position of the needle/cannula in a patient by adjusting the depth of the needle/cannula in order to reduce irritation of the subcutaneous layer (see Skutnik, col. 22, ll. 5-57, and fig. 14). It would have been obvious to person of ordinary skill in the art before the effective filing to modify the device of Schmid with the teachings of Yodfat et al. and Skutnik et al. so that the device of Schmid in a first state, the sliding member and the linkage coupled to the drive mechanism have over-traveled a stop beam, thereby creating a cavity beyond a distal tip of the insertion member beneath the surface of the skin, and in a second state, the sliding member is lodged against the stop beam after being retracted by the linkage (and the linkage is returned to an initial position) because Yodfat et al., teaches different mechanisms that engage sliding member with an insertion member so that the depth level can be adjusted and allow the member to move in both a forward and backward direction. Additionally, Skutnik et al. teaches the benefit for retracting an insertion member/(cannula/needle) after insertion so that tissue trauma can be reduced. Specifically, one of ordinary skill in the art would understand and only use routine skill to modify the sliding member of Schmid (as pictured in fig. 3, 5, 9, 10) to include a receiving structure such as a recess and a groove ( recess already taught in fig. 5 of Schmid) in order to catch the stop beam (latch) of the frame because the prior art (Yodfat et al.) teaches latches/flanges/protrusions of the insertion member engaging with grooves of the housing as a commonly used engagement mechanism . Furthermore, it would have been obvious to modify the size of the recess since one of ordinary skill in the art would understand that additional spacing in the recess of the sliding member would allow the insertion member to engage and pass the stop beam (latch) so that the insertion member will be fully inserted. By providing additional spacing in the recess, the insertion member be full inserted without being locked in place by the stop beam (latches). Additionally by having additional space, the insertion member can retract and be adjusted to a proper distance since this will help to reduce trauma (as taught by Skutnik). After the modification of Schmid with Yodfat et al. and Skutnik, the combined device would meet the intended use of creating a cavity beyond a distal tip of the insertion member beneath the surface of the skin in a first state, because the needle would over-travel the stop beam and retract slightly in the sliding recess for the benefit of reducing trauma to the patient (as taught by Skutnik). Lastly, it would have been obvious to one of ordinary skill in the art to modify the combined device of Schmid , Yodfat et al. a nd Skutnik above so that the combined device includes a second state, in which the sliding member is lodged against the stop beam after being retracted by the linkage and wherein the linkage is returned to an initial position in the second state because this is an obvious modification by one of ordinary skill in the art and would yield predictable results. Schmid already teaches the linkage is returned to an initial position in the second state as illustrated in figure 5 (and fig. 28 in other embodiments) as well as the linkage controlling the movement of the sliding members, (see figures 3 and 5, and 9, 10), thus it would have been obvious that the modified combined device of Schmid, Yodfat et al. and Skutnik as explained above would have the linkage control the retraction of the sliding members, since this is how Schmid operates , thus making it obvious for the linkage to retract the sliding member which in turn would have the sliding member engage/lodge the stop beam (latch) of the modified device of Schmid, Yodfat et al. and Skutnik based on the combined modification and how the device of Schmid operates. With regards to claim 11, the combined device of Schmid , Yodfat et al., and Skutnik et al. teaches the insertion member is coupled to a fluid pathway from a reservoir (para. 0064-0066, as taught by Schmid). With regards to claims 12 , 13 , Schmid teaches the drive mechanism further comprises a drive force such as a spring element that acts on the linkage to advance the sliding member toward the stop beam (181/281). With regards to claim 14 , the combined device of Schmid , Yodfat et al., and Skutnik et al. teaches the sliding member including a sliding recess operable to capture the stop beam and limit movement of the sliding member to allow the overtravel of the sliding member as modified in claim 1 0 above. Therefore, it would have been obvious to include a sliding recess operable to capture the stop beam and limit movement of the sliding member to allow the overtravel of the sliding member because Schmid teaches a recess that captures a stop beam (along with the modification made in claim 1 0 ) thus making the modification an obvious modification to one ordinary skill in the art. With regards to claim 15 , the combined device of Schmid , Yodfat et al., and Skutnik et al., teaches a guide (290 as taught by Schmid) configured to direct the sliding member toward the stop beam. With regards to claim 16 , the combined device of Schmid , Yodfat et al., and Skutnik et al. teaches the sliding member further comprises a first sliding member (186/286 as taught by Schmid) coupled to the insertion member; and a second sliding member (184/284 as taught by Schmid) coupled to the linkage (283a,b as taught by Schmid), wherein the first sliding member is configured with a sliding member recess operable to capture the stop beam and limit movement of the sliding member to allow the overtravel of the first sliding member (as modified by in claim 1 0 above). With regards to claim 20 , the combined device of Schmid , Yodfat et al., and Skutnik et al. teaches the drive mechanism is actuated by a manual mechanism, an electronic circuit or a combination of both (para. 0087 as taught by Schmid). With regards to claim 19, the modified device as explained above for claim 10, teaches the stop beam is operable to facilitate over-travel of the sliding member past the stop beam and allow the sliding member to retract until lodged against the stop beam to thereby cause the insertion member to retract from a first insertion position to a second insertion position because of the modification of the sliding member recess of Schmid, which would allow facilitate over-travel of the sliding member past the stop beam and allow the sliding member to retract until lodged against the stop beam to thereby cause the insertion member to retract from a first insertion position to a second insertion position. Claims 1 7, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Schmid (US Pub. 2016/0361013) , Yodfat et al. (US Pub. 2012/0259185) , Skutnik et al. (US 9,782,536) and further in view of Ahm et al. (US Pub. 20090012472) . With regards to claim s 17 and 18 , the combined device of Schmid , Yodfat et al . , Skutnik et al. teach the claimed device except for the sliding member further comprises a coupling that is operable to join the first sliding member to the second sliding member (clm 17) and the coupling is further operable to decouple from the first sliding member and the second sliding member , when the drive mechanism is in the second state (clm 18) . Ahm et al. teaches a first sliding member/lower member 653 coupled to a second sliding member/upper member 663 (see fig. 13A) and become released (the coupler is released, see para. 0083) when the members reach a second state (see fig. 13B). It would have been obvious to person of ordinary skill in the art before the effective filing to modify the modified combined device of Schmid , Yodfat et al. , and Skutnik et al. , with the teachings of Ahm et al. to arrive at the claimed invention. It would have been obvious to modify the sliding member to further include a coupling mechanism that is operable to join the first sliding member to the second sliding member of the combined device of Schmid, Yodfat et al., and Skutnik et al. (clm 17) and configure the coupling so that the coupling is further operable to decouple from the first sliding member and the second sliding member, when the drive mechanism is in the second state (clm 18) because Ahm et al. teaches a coupling member that locks the two sliding members together during an initial state (first state) and is released when the lower member reaches it proper location (second state) so that the needle can be retracted and the cannula can stay in the proper location. Furthermore, Ahm et al. teaches the level of skill in the art, thus teaching what is routine and conventional and what would yield predictable results. Therefore, it would have been obvious for one of ordinary skill in the art to modify the sliding members of Schmid, Yodfat et al., and Skutnik et al. to include a coupling (coupling mechanism) that is operable to join the first sliding member to the second sliding member (clm 17) and the coupling is further operable to decouple from the first sliding member and the second sliding member, when the drive mechanism is in the second state (clm 18) in order to maintain the sliding members together in an initial state and decouple/ separate the first and second sliding members in a second state in order for the needle to be retracted (this is how Schmid operates as well as how the prior art operates). One of ordinary skill in the art would have found it obvious and would have only used routine skill in the art to add a coupling to the first and second sliding members based on the prior art teachings. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT MATTHEW F DESANTO whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-4957 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 7:30am-4pm(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. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Boyer Ashley can be reached at (571) 272-4502 . 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. /MATTHEW F DESANTO/ Primary Examiner, Art Unit 3700