CTNF 18/293,191 CTNF 94752 DETAILED ACTION 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. Specification The disclosure is objected to because of the following informalities: In [0033], ln 4, the “outer surface” feature is incorrectly given reference number 84, which belongs to the “inner surface.” Appropriate correction is required. Applicant(s) are encouraged to further review the specification for other such reference number inconsistencies not initially noticed by the examiner. Claim Rejections - 35 USC § 112 07-30-01 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. 07-31-01 Claims 1-8, 12-14, and 20 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. Regarding claims 1-8, the limitation “said holder configured for … moving the injection delivery device in a distal direction relative to the holder and the adapter” of claim 1 is 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. Specifically, neither the text nor the figures of the present application discuss that the holder is configured for moving the injection delivery device relative to itself. It is clear from the structure of the holder as given in Fig. 1-14 and associated text that the holder cannot move the injection delivery device relative to itself, since the holder is an entirely solid and integral component, with no portion of the holder being movable relative to itself, and with no means of moving the injection delivery device (such as a motorized drive portion) relative to the remainder of the holder. Rather, the holder is only capable of moving the injection device relative to the adapter and guide portions of the claimed support device. It is likely that the applicant inadvertently included the “holder” in place of the “guide” structure within the latter portion of the above cited limitation, as would have been consistent with the other independent claims 9 and 18. Further, while the above cited limitation is included within an originally filed claim, MPEP 2163(I)(A) states that “… issues of adequate written description may arise even for original claims, for example, when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the inventor had possession of the claimed invention at the time of filing. The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional or known in the art.” The above cited limitation requires that the holder be capable of both supporting and moving the injection device relative to itself. Such capability requires that at least a portion of the holder, which contacts or drives the injection device, be movable relative to the rest of the holder. Such a portion is not depicted or described within the specification – in fact, it is incompatible with the configuration described within the specification and depicted in the figures of the present invention. Such a configuration (as would incorporate the above cited limitation in conjunction with the configuration of the specification) would therefore also be considered not conventional or known within the art. Appropriate correction or cancelation is required. Dependent claims 2-8 do not remedy the issue described. Being dependent upon claim 1, and thus incorporating the above cited limitation, these claims are also rejected for the same reason as in re claim 1. Regarding claims 12-14, the limitation “where said holder is received in said collar” of claim 12 is 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. Specifically, neither the text nor the figures of the present application discuss that the holder is received in the collar at any point during operation of the device. It is clear from the structure of the holder as given in Fig. 4, 8, and 11-14 and associated text that no portion of the holder can move within the collar portion of the adapter, the outer portion of the holder being limited to move externally to the guide, thereby blocked from accessing the collar, and the coupling portions of the holder being limited by the fact that the slots formed within the guide do not extend within the collar portion of the adapter. It is likely that the applicant inadvertently included the “holder” in place of the “guide” structure within the above cited limitation, as would have been consistent with [0031] of the specification. Further, while the above cited limitation is included within an originally filed claim, MPEP 2163(I)(A) states that “… issues of adequate written description may arise even for original claims, for example, when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the inventor had possession of the claimed invention at the time of filing. The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional or known in the art.” The above cited limitation requires that the holder be capable of moving within the collar portion of the adapter. Such capability is not depicted or described within the specification – in fact, it is incompatible with the configuration described within the specification and depicted in the figures of the present invention. Such a configuration (as would incorporate the above cited limitation in conjunction with the configuration of the specification) would therefore also be considered not conventional or known within the art. Appropriate correction or cancelation is required. Dependent claims 13 and 14 do not remedy the issue described. Being dependent upon claim 12, and thus incorporating the above cited limitation, these claims are also rejected for the same reason as in re claim 12. Regarding claim 20, the limitation “wherein said guide includes a tab extending between said holder and said coupling member, wherein said tab slides in a slot of the guide” of claim 20 is 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. Specifically, neither the text nor the figures of the present application discuss that the guide includes a tab as claimed. Rather, the figures and specification disclose that the holder comprises a tab configured in the manner claimed (see Fig. 3-4 and 11, and [0033] of the present specification). It is likely that the applicant inadvertently included the “guide” term in place of the “holder” structure within the first portion of the above cited limitation, as would have been consistent with specification. Further, while the above cited limitation is included within an originally filed claim, MPEP 2163(I)(A) states that “… issues of adequate written description may arise even for original claims, for example, when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the inventor had possession of the claimed invention at the time of filing. The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional or known in the art.” The above cited limitation requires that the guide comprise a tab extending between said holder and said coupling member, wherein said tab slides in a slot of the guide. Such capability is not depicted or described within the specification – in fact, it is incompatible with the configuration described within the specification and depicted in the figures of the present invention, wherein only the holder is described as comprising such a tab. Such a configuration (as would incorporate the above cited limitation in conjunction with the configuration of the specification) would therefore also be considered not conventional or known within the art. Appropriate correction or cancelation is required. 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. 07-34-01 Claim 20 is 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. In claim 20 , the limitation “a tab extending between said holder and said coupling member” renders the claim indefinite, since the coupling member is defined as a part of the holder as per claim 18, upon which claim 20 depends. As such, the meaning of “between said holder and said coupling member” is rendered unclear, since it is unclear how the tab (or any feature) may be defined as being positioned between a portion of the holder and the holder as a whole, which includes the same portion of the holder. Appropriate correction is required. Because the claim language used cannot be interpreted in view of the specification in any manner which is definite, the claim is not examined over the prior art. However, such should not be taken as an indication of allowable subject matter. Claim Rejections - 35 USC § 102 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. 07-12-aia AIA (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. 07-15 AIA Claim (s) 1-4 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Gottinger (U.S. Pat. No. 4,403,987) . Regarding claim 1, Gottinger discloses a support for an injection delivery device (syringe 10) (see Fig. 1-2 and Col. 2, ln 59 – Col. 3, ln 7) comprising: an adapter (assembly of plate 54 and pinch bars 40 and 42) having at least two movable arms (pinch bars 40 and 42), each arm having a proximal end (proximal end region including vertical rod portions 36, 38) movable relative to each other (the proximal end region of the pinch bars 40, 42 must rotate/twist relative to the plate and each other when the pinch bars 40, 42 are opened/closed at their distal ends) and a distal end (clamping arm portions 44, 46) configured for engaging and pinching tissue of a patient to form a raised area of the tissue (see Fig. 1-2 and Col. 3, ln 35 – Col. 4, ln 6); a guide (guide rods 20, 22) coupled to said adapter and oriented between said at least two arms (see Fig. 1-2 and Col. 3, ln 8-23); and a holder (assembly of plate 14, spring clips 18, spring 56, and disc 58) coupled to said guide (elastically, via disc 58), said holder configured for supporting the injection delivery device and for moving the injection delivery device in a distal direction relative to the holder and the adapter to deliver a medication to the tissue pinched between said arms (see Fig. 1-2 and Col. 4, ln 17-63, wherein the plate 14 portion of the holder supports the injection delivery device 10 via spring clips 18 and carries the injection delivery device 10 distally relative to the disc 58 portion of the holder and the adapter assembly during injection, thereby moving the injection delivery device 10 distally relative to at least a portion of the holder assembly). Regarding claim 2, Gottinger further discloses that said injection delivery device has a needle (needle 12) extending in a distal direction for delivering the medication to the tissue pinched between said arms (see Fig. 1-2 and Col. 2, ln 59 – Col. 3, ln 23). Regarding claim 3, Gottinger further discloses that said injection delivery device is a syringe (see Fig. 1-2 and Col. 2, ln 59 – Col. 3, ln 23). Regarding claim 4, Gottinger further discloses that said adapter is a one-piece, unitary member having a body with said arms extending distally from said body (see Fig. 1-2 and Col. 3 ln 50-66, wherein the pinch bars40, 42 and the plate 54 are integrally formed), and where said arms are biased toward each other to pinch the tissue of the patient (by coil spring 50 – see Fig. 1-2 and Col. 4, ln 7-16) . 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) 9-10 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Imai (U.S. Pat. Pub. No. 2016/0331910 A1) in view of Milorad (U.S. Pat. No. 4,702,739), Lazic (U.S. Pat. Pub. No. 2019/0090878 A1), and Michels (U.S. Pat. Pub. No. 2017/0232209 A1) . Regarding claim 9, Imai discloses a support for an injection delivery device (syringe 103) for delivering a medication to a patient (see Fig. 9-14B and [0087-0088]), said support comprising: an adapter (puncture assisting device 102) having a body (assembly of 121 and connected hinge pieces 111b, 112b) with an axial passage (121a) and two arms (pinching pieces 111, 112) extending in a distal direction from said body (see Fig. 9-14B, [0089-0091], [0093], and [0105-0106]), and where said arms are biased inwardly toward each other and said axial passage (via C-springs 115 or an alternative biasing arrangement), said arms configured for pinching tissue of a patient between said arms (see Fig. 9-14B, [0096-0102], [0104], and [0107]). Imai fails to teach that said adapter is a one-piece, unitary member, Imai instead exhibiting that the arms (111, 112) are joined with each other and the body at a hinge (111b, 112b) connection, this configuration cooperating with C-spring 115 to create arms that are biased towards closing. However, Imai also contemplates other configurations for providing biased arms, including the use of elastic material ([0101]). Further, it is well known in the art, as taught by Lazic, that such clamping structures as that of Imai can be formed instead as a one-piece, unitary member made of elastic material, such that the arms may be biased towards being in the closed position. Such is shown by Lazic, which exhibits a surgical clip (1) similar to the adapter taught by Imai, the surgical clip comprising two arms (clamping arms 2) connected to each other by a body portion (connection portion 4) and biased towards being in the closed position relative to each other (see Fig. 1a-1c, [0007-0008], and [0021-0024]). Lazic teaches that such a structure may be as a one-piece, unitary member made of elastic material (see Fig. 1a-1c and, [0007-0008], and [0021-0022]). Based on the teachings and example of Lazic, and upon Imai’s own suggestion, it would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the adapter of Imai to be formed instead as a one-piece, unitary member made of elastic material, such that the arms may be biased towards being in the closed position, in the manner taught by Lazic, as a matter of simple substitution of one functionally equivalent means of providing biased arms known within the art (that taught by Lazic) for another (that of Imai) in order to obtain predictable results - that the arms may be biased towards being in the closed position. See MPEP 2143(I)(B). Further, it is well understood within the art that such a modification would replace the hinged connection between the arms and body of the adapter of Imai with continuous elastic body material, such as may still include the axial passage structure within the body as taught by Imai. Further, while Imai does teach that the body of the adapter comprises a collar (syringe insertion portion 121) configured to guide and receive the injection delivery device for introducing a needle (needle 132) of said injection delivery device into the tissue captured between said arms (see Fig. 9-14B, [0105-0108], and [0112-0128]), Imai fails to teach a guide removably coupled to said adapter, said guide having an axial passage aligned with said axial passage of said adapter; and a holder coupled to said guide, said holder having a coupling member configured for coupling to the injection delivery device, said holder configured for sliding said injection delivery device in an axial direction relative to said guide and adapter for introducing a needle of said injection delivery device into the tissue captured between said arms. Such features are, however, known in the art. Milorad, for example, exhibits a support for an injection delivery device (syringe 30) for delivering a medication to a patient, this support comprising a guide (sleeve 90) having an axial passage (see Fig. 4 and 6, and Col. 6, ln 3-58); and a holder (holder 82) coupled to said guide (see Fig. 4 and 6, and Col. 6, ln 3-58), said holder having a coupling member (set screw 110) configured for coupling to the injection delivery device (see Fig. 4 and Col. 6, ln 50-58), said holder configured for sliding said injection delivery device in an axial direction relative to said guide for introducing a needle of said injection delivery device into the tissue against which the distal end of the guide may be pressed (see Fig. 1a-1c, 4, and 6, Col. 4, ln 6-65, and Col. 6, ln 3-58). Milorad teaches that providing such structures improves the injection process by reducing patient pain (by ensuring the same insertion force is always used) and discomfort (by hiding the needle from sight) (Col. 1, ln 7-30 and Col. 2, ln 1-21). Since both Imai and Milorad describe supports for delivering a medication to a patient via injection, and since Milorad describes advantages to providing guide and holder structures extending well beyond the guiding collar of Imai, it would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to augment the adapter of Imai to include a guide and a holder such as taught by Milorad in addition to the collar of Imai, these structures augmenting the collars’ function of introducing a needle of said injection delivery device into the tissue captured between said arms by facilitating reducing patient pain (such as by ensuring the same insertion force is always used) and discomfort (such as by hiding the needle from sight) throughout the injection, as described by Milorad (Col. 1, ln 7-30 and Col. 2, ln 1-21) . As part of such a modification, one of ordinary skill in the art must necessarily align the axial passage of the guide with that of the adapter, in order to thereby allow the injection delivery device to pass through both axial passages. One of ordinary skill in the art would also couple the guide to the adapter, and it is well known within the art that such needle-delivery devices (adapter and syringe guiding features) may be separably coupled, such as is exemplified by Michels (see Fig. 8-10 and [0020], and [0027-0029], wherein a needle carrying cap 110 is removably coupled to an adapter 100 configured to capture tissue for supporting an injection in a similar manner to the adapter of Imai). Upon such a modification, the support of Imai would therefore comprise a guide removably coupled to said adapter, said guide having an axial passage aligned with said axial passage of said adapter; and a holder coupled to said guide, said holder having a coupling member configured for coupling to the injection delivery device, said holder configured for sliding said injection delivery device in an axial direction relative to said guide and adapter for introducing a needle of said injection delivery device into the tissue captured between said arms, as claimed. Regarding claim 10, Imai further discloses that the adapter may be made of a spring metal ([0090], wherein the adapter may be made of metal such as stainless steel or aluminum alloy, each of which is known to elastically deform over a range of applied forces and therefore may be considered a spring metal). Lazic also teaches that the clip may be made of a spring metal (laser-cut metal sheet – see [0022]). Regarding claim 18, Imai discloses a method of injecting a medication into subcutaneous tissue of a patient, said method comprising; positioning a support (see in re claim 9) against a patient ([0112-0114]), said support including an adapter having a body with an axial passage and two arms extending in a distal direction from said body (see in re claim 9), and where said arms are biased inwardly toward each other and configured for pinching tissue of a patient between said arms (see in re claim 9); expanding the arms of the support outwardly and releasing the arms to pinch the subcutaneous tissue of the patient to form a pinched surface ([0114-0117]). Imai may be modified according to the teachings of Milorad, Lazic, and Michels (see in re claim 9), such that the support assembly further includes a guide removably coupled to said adapter, said guide having an axial passage aligned with said axial passage of said adapter; and a holder coupled to said guide, said holder having a coupling member configured for coupling to the injection delivery device, said holder configured for sliding said injection delivery device in an axial direction relative to said guide and said adapter for introducing a needle of said injection delivery device into the tissue between said arms (see in re claim 9). It follows that the proposed combination also exhibits the method step, therefore, of coupling the holder and guide to the adapter. Milorad further teaches that the guide and holder configuration incorporated into Imai requires the loading step of coupling the injection delivery device into the holder and guide (Col. 2, ln 22-30 and Col. 6, ln 47-58), and the injection step of sliding said holder and injection device relative to said guide and adapter to insert the needle into the subcutaneous tissue (see Fig. 1a-1b, Col. 4, ln 6-14 and ln 46- 65). Upon the incorporation of the guide and holder configuration taught by Milorad into the support assembly of Imai, it would naturally follow, based upon these teachings and the structural configuration of the guide and holder, that the proposed combination would also require the loading step of coupling the injection delivery device into the holder and guide, and that the proposed combination would operate as a result of the combination by the injection step of sliding said holder and injection device relative to said guide and adapter to insert the needle into the subcutaneous tissue, thereby delivering the medication to the patient . 07-21-aia AIA Claim (s) 11-13 is rejected under 35 U.S.C. 103 as being unpatentable over Imai as modified by Milorad, Lazic, and Michels according to claim 9, and in further view of Buysman (WIPO Pub. No. 2007/047813 A2) . Regarding claim 11, Imai fails to teach that each of said arms of said body include a distal end with a tab extending outwardly and proximally relative to said adapter. Instead, the arms of Imai are provided with lever arms (gripping portions 116, 117) that extend proximally from the distal end of each respective arm (see Fig. 9 and [0102-0103]). Such is done to provide the user with a means of opening the arms against the bias of the arms towards a closed state (such bias described above in re claim 9). However, Imai further teaches that alternative means of biasing the arms may be used instead of the configuration depicted ([0101], ln 5-9). Indeed, Imai is modified in re claim 9 such that the adapter portion is a one piece, unitary, and elastic assembly comprising the arms and lever arms (see in re claim 9). However, alternative means of opening the arms are known in the art. Buysman, for example, exhibits a support assembly (10, see Fig. 1-5) for aiding in delivering a needle (185) into the skin (167) of a patient, the assembly comprising an integral adapter portion (clamp 20) formed with two biased arms (jaws 30, 35) extending distally from a body portion (central member 40) thereof and being configured to pinch the skin of the patient in preparation for injection, in a similar manner to that of Imai (see Fig. 1-5 and pg. 6, ln 10 – pg. 7, ln 7). Yet, Buysman teaches that each of said biased arms of said body include a distal end with a tab (levers 50, 55) extending outwardly and proximally relative to said adapter, in order to allow the user to open the arms against the bias of the arms towards a closed state by squeezing together the tabs of the two arms (pg. 7, ln 1-7). Since this means of opening biased arms within a clamping adapter portion of a similar support device to that of Imai may be recognized as a functional equivalent known to be suitable within the art as an alternative to that of Imai, it would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the adapter of Imai such that each of said arms of said body include a distal end with a tab extending outwardly and proximally relative to said adapter instead of comprising lever arms as a matter of simple substitution of one known means of opening biased arms (that of Buysman) for another (that of Imai), obtaining the same capability in an alternative but functionally equivalent manner. See MPEP 2143(I)(B). Regarding claim 12, while Imai teaches that said body of said adapter has a distal face with a distally extending collar surrounding said axial passage and extending between said arms (see Fig. 9-14B and [0105-0108]), Imai fails to teach that said holder is received in said collar. However, Imai is modified in view of Michels and Milorad in re claim 9 such that the collar of Imai is augmented by the addition of a guide and holder as taught by Milorad (see in re claim 9). Since the guide portion of Milorad is intended to contact the skin of the patient within the guide/holder configuration of Milorad (see Fig. 1a-1c, and Col. 4, ln 44-65), and since the holder of Milorad is designed to be received within the distal end of the guide during injection (see Fig. 1a-1b and 3-6, and Col. 4, ln 44-65), it follows that in order to retain the intended functionality of the holder and guide of Milorad within the setting of the adapter of Imai, one of ordinary skill in the art would have configured the holder such that the holder is received in said collar of Imai during injection in the same manner as it is within the distal end of the guide in Milorad. Regarding claim 13, while the distally extending collar of Imai does not have a length to contact the tissue pinched between said arms, because the guide portion of Milorad is intended to contact the skin of the patient within the guide/holder configuration of Milorad in order to thereby ensure that the holder delivers the needle with a proper injection depth (see Fig. 1a-1b and 3-6, and Col. 4, ln 44-65), and such is incorporated into the support assembly of Imai as augmenting the collar of Imai (with axial passages aligned), it would have been obvious it follows that in order to retain the intended functionality of the holder and guide of Milorad within the setting of the adapter of Imai, one of ordinary skill in the art would have configured the collar to extend having a length to contact the tissue pinched between said arms in the same manner as the guide of Milorad, thereby ensuring that proper injection depth may be delivered by the holder . 07-21-aia AIA Claim (s) 9-10 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Imai in view of Perthu (U.S. Pat. Pub. No. 2019/0307968 A1), Lazic, and Michels . Regarding claim 9, Imai discloses a support for an injection delivery device (syringe 103) for delivering a medication to a patient (see Fig. 9-14B and [0087-0088]), said support comprising: an adapter (puncture assisting device 102) having a body (assembly of 121 and connected hinge pieces 111b, 112b) with an axial passage (121a) and two arms (pinching pieces 111, 112) extending in a distal direction from said body (see Fig. 9-14B, [0089-0091], [0093], and [0105-0106]), and where said arms are biased inwardly toward each other and said axial passage (via C-springs 115 or an alternative biasing arrangement), said arms configured for pinching tissue of a patient between said arms (see Fig. 9-14B, [0096-0102], [0104], and [0107]). Imai fails to teach that said adapter is a one-piece, unitary member, Imai instead exhibiting that the arms (111, 112) are joined with each other and the body at a hinge (111b, 112b) connection, this configuration cooperating with C-spring 115 to create arms that are biased towards closing. However, Imai also contemplates other configurations for providing biased arms, including the use of elastic material ([0101]). Further, it is well known in the art, as taught by Lazic, that such clamping structures as that of Imai can be formed instead as a one-piece, unitary member made of elastic material, such that the arms may be biased towards being in the closed position. Such is shown by Lazic, which exhibits a surgical clip (1) similar to the adapter taught by Imai, the surgical clip comprising two arms (clamping arms 2) connected to each other by a body portion (connection portion 4) and biased towards being in the closed position relative to each other (see Fig. 1a-1c, [0007-0008], and [0021-0024]). Lazic teaches that such a structure may be as a one-piece, unitary member made of elastic material (see Fig. 1a-1c and, [0007-0008], and [0021-0022]). Based on the teachings and example of Lazic, and upon Imai’s own suggestion, it would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the adapter of Imai to be formed instead as a one-piece, unitary member made of elastic material, such that the arms may be biased towards being in the closed position, in the manner taught by Lazic, as a matter of simple substitution of one functionally equivalent means of providing biased arms known within the art (that taught by Lazic) for another (that of Imai) in order to obtain predictable results - that the arms may be biased towards being in the closed position. See MPEP 2143(I)(B). Further, it is well understood within the art that such a modification would replace the hinged connection between the arms and body of the adapter of Imai with continuous elastic body material, such as may still include the axial passage structure within the body as taught by Imai. Further, while Imai does teach that the body of the adapter comprises a collar (syringe insertion portion 121) configured to guide and receive the injection delivery device for introducing a needle (needle 132) of said injection delivery device into the tissue captured between said arms (see Fig. 9-14B, [0105-0108], and [0112-0128]), Imai fails to teach a guide removably coupled to said adapter, said guide having an axial passage aligned with said axial passage of said adapter; and a holder coupled to said guide, said holder having a coupling member configured for coupling to the injection delivery device, said holder configured for sliding said injection delivery device in an axial direction relative to said guide and adapter for introducing a needle of said injection delivery device into the tissue captured between said arms. Such features are, however, known in the art. Perthu, for example, exhibits a support for an injection delivery device (syringe, see Fig. 18-25 and [0359]) for delivering a medication to a patient, this support comprising a guide (needle shield 302, part of housing 301) having an axial passage (see Fig. 18-25, and [0369]); and a holder (moveable element 310, which comprises syringe holder 314) coupled to said guide (via housing 301, within which moveable element 310 is slidably housed - see Fig. 18-25 and [0359-0360], and [0369]), said holder having a coupling member (gripping arms 315, 316) configured for coupling to the injection delivery device (see Fig. 18-25 and [0359]), said holder configured for sliding said injection delivery device in an axial direction relative to said guide for introducing a needle of said injection delivery device into the tissue against which the distal end of the guide may be pressed (see Fig. 18-25 and [0360-0366]). Perthu teaches that providing such structures improves the injection process by protecting the injection administrator from accidental needle contact (by virtue of the needle being contained within needle shield 302 before and after injection – see [0022-0023]) and by preventing patient discomfort (by hiding the needle – see [0375]). Since both Imai and Perthu describe supports for delivering a medication to a patient via injection, and since Perthu describes advantages to providing guide and holder structures extending well beyond the guiding collar of Imai, it would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to augment the adapter of Imai to include a guide and a holder such as taught by Perthu in addition to the collar of Imai, these structures augmenting the collars’ function of introducing a needle of said injection delivery device into the tissue captured between said arms by protecting the injection administrator from accidental needle contact and preventing patient discomfort (both by virtue of the needle being contained within the extended guide before and after injection), as described by Perthu ([0022-0023] and [0375]). As part of such a modification, one of ordinary skill in the art must necessarily align the axial passage of the guide with that of the adapter, in order to thereby allow the injection delivery device to pass through both axial passages. One of ordinary skill in the art would also couple the guide to the adapter, and it is well known within the art that such needle-delivery devices (adapter and syringe guiding features) may be separably coupled, such as is exemplified by Michels (see Fig. 8-10 and [0020], and [0027-0029], wherein a needle carrying cap 110 is removably coupled to an adapter 100 configured to capture tissue for supporting an injection in a similar manner to the adapter of Imai). Upon such a modification, the support of Imai would therefore comprise a guide removably coupled to said adapter, said guide having an axial passage aligned with said axial passage of said adapter; and a holder coupled to said guide, said holder having a coupling member configured for coupling to the injection delivery device, said holder configured for sliding said injection delivery device in an axial direction relative to said guide and adapter for introducing a needle of said injection delivery device into the tissue captured between said arms, as claimed. Regarding claim 10, Imai further discloses that the adapter may be made of a spring metal ([0090], wherein the adapter may be made of metal such as stainless steel or aluminum alloy, each of which is known to elastically deform over a range of applied forces and therefore may be considered a spring metal). Lazic also teaches that the clip may be made of a spring metal (laser-cut metal sheet – see [0022]). Regarding claim 16, Perthu further teaches that said holder includes a body (syringe holder 314) with an inner surface (flat surface upon which gripping arms 315, 316 are mounted) for sliding on an outer surface of said guide (see Fig. 22), and where said coupling member (gripping arm 316) of said holder slides on an inner surface of said guide (see Fig. 22 and [0359]). Because a holder and guide as taught by Perthu are incorporated into the support assembly of Imai in the proposed combination (see in re claim 9), it follows that the proposed combination also exhibits these features. Regarding claim 17, Perthu further teaches that said guide includes a longitudinally extending opening, and where said coupling member of said holder extends through said longitudinally extending opening (see Fig. 18-22 and [0359], wherein the needle guard 302 comprises a longitudinally extending slot which receives the coupling member 316 when the holder is positioned for injection, as in Fig. 18, 19, and 22). Because a holder and guide as taught by Perthu are incorporated into the support assembly of Imai in the proposed combination (see in re claim 9), it follows that the proposed combination also exhibits these features. Regarding claim 18, Imai discloses a method of injecting a medication into subcutaneous tissue of a patient, said method comprising; positioning a support (see in re claim 9) against a patient ([0112-0114]), said support including an adapter having a body with an axial passage and two arms extending in a distal direction from said body (see in re claim 9), and where said arms are biased inwardly toward each other and configured for pinching tissue of a patient between said arms (see in re claim 9); expanding the arms of the support outwardly and releasing the arms to pinch the subcutaneous tissue of the patient to form a pinched surface ([0114-0117]). Imai may be modified according to the teachings of Perthu, Lazic, and Michels (see in re claim 9), such that the support assembly further includes a guide removably coupled to said adapter, said guide having an axial passage aligned with said axial passage of said adapter; and a holder coupled to said guide, said holder having a coupling member configured for coupling to the injection delivery device, said holder configured for sliding said injection delivery device in an axial direction relative to said guide and said adapter for introducing a needle of said injection delivery device into the tissue between said arms (see in re claim 9). It follows that the proposed combination also exhibits the method step, therefore, of coupling the holder and guide to the adapter. Perthu further teaches that the guide and holder configuration incorporated into Imai requires the loading step of coupling the injection delivery device into the holder and guide (see Fig. 24-25 and [0359]), and the injection step of sliding said holder and injection device relative to said guide and adapter to insert the needle into the subcutaneous tissue (see Fig. 21-22 and 24-25, and [0360-0366]). Upon the incorporation of the guide and holder configuration taught by Milorad into the support assembly of Imai, it would naturally follow, based upon these teachings and the structural configuration of the guide and holder, that the proposed combination would also require the loading step of coupling the injection delivery device into the holder and guide, and that the proposed combination would operate as a result of the combination by the injection step of sliding said holder and injection device relative to said guide and adapter to insert the needle into the subcutaneous tissue, thereby delivering the medication to the patient. Regarding claim 19, Perthu further teaches that said holder includes a body (syringe holder 314) that slides on an outer surface of said guide (see in re claim 16), and where said coupling member (gripping arm 316) of said holder slides on an inner surface of said guide (see in re claim 16). Because a holder and guide as taught by Perthu are incorporated into the support assembly of Imai in the proposed combination (see in re claim 9), it follows that the proposed combination also exhibits these functionalities . 07-21-aia AIA Claim (s) 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Imai as modified by Perthu, Lazic, and Michels according to claim 9, and in further view of Buysman (U.S. Pat. Pub. No. 2008/0281269 A1) . Regarding claim 11, Imai fails to teach that each of said arms of said body include a distal end with a tab extending outwardly and proximally relative to said adapter. Instead, the arms of Imai are provided with lever arms (gripping portions 116, 117) that extend proximally from the distal end of each respective arm (see Fig. 9 and [0102-0103]). Such is done to provide the user with a means of opening the arms against the bias of the arms towards a closed state (such bias described above in re claim 9). However, Imai further teaches that alternative means of biasing the arms may be used instead of the configuration depicted ([0101], ln 5-9). Indeed, Imai is modified in re claim 9 such that the adapter portion is a one piece, unitary, and elastic assembly comprising the arms and lever arms (see in re claim 9). However, alternative means of opening the arms are known in the art. Buysman, for example, exhibits a support assembly (10, see Fig. 1-5) for aiding in delivering a needle (185) into the skin (167) of a patient, the assembly comprising an integral adapter portion (clamp 20) formed with two biased arms (jaws 30, 35) extending distally from a body portion (central member 40) thereof and being configured to pinch the skin of the patient in preparation for injection, in a similar manner to that of Imai (see Fig. 1-5 and pg. 6, ln 10 – pg. 7, ln 7). Yet, Buysman teaches that each of said biased arms of said body include a distal end with a tab (levers 50, 55) extending outwardly and proximally relative to said adapter, in order to allow the user to open the arms against the bias of the arms towards a closed state by squeezing together the tabs of the two arms (pg. 7, ln 1-7). Since this means of opening biased arms within a clamping adapter portion of a similar support device to that of Imai may be recognized as a functional equivalent known to be suitable within the art as an alternative to that of Imai, it would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the adapter of Imai such that each of said arms of said body include a distal end with a tab extending outwardly and proximally relative to said adapter instead of comprising lever arms as a matter of simple substitution of one known means of opening biased arms (that of Buysman) for another (that of Imai), obtaining the same capability in an alternative but functionally equivalent manner. See MPEP 2143(I)(B). Regarding claim 12, while Imai teaches that said body of said adapter has a distal face with a distally extending collar surrounding said axial passage and extending between said arms (see Fig. 9-14B and [0105-0108]), Imai fails to teach that said holder is received in said collar. However, Imai is modified in view of Michels and Perthu in re claim 9 such that the collar of Imai is augmented by the addition of a guide and holder as taught by Perthu (see in re claim 9). Since the guide portion of Perthu is intended to contact the skin of the patient within the guide/holder configuration of Perthu ([0022]), and since the holder of Perthu is designed to be received within the guide during injection (see Fig. 22), it follows that in order to retain the intended functionality of the holder and guide of Perthu within the setting of the adapter of Imai, one of ordinary skill in the art would have configured the holder such that the holder is received in said collar of Imai during injection in the same manner as it is within the guide in Perthu . 07-21-aia AIA Claim (s) 15 are rejected under 35 U.S.C. 103 as being unpatentable over Imai as modified by Perthu, Lazic, and Michels according to claim 9, and in further view of Gottinger . Regarding claim 15, Perthu does not explicitly teach that said coupling member of said holder includes a flexible coupling member for coupling to the injection delivery device (Perthu merely designating gripping arms 315, 316 without reference to their flexibility). It is, however, well known within the art that coupling members of this type may be made flexible. Gottinger, for example, exhibits coupling members (spring clips 18) of the same type as those of Perthu, and designates them as “spring clips”, thereby disclosing that they are flexible (Col. 3, ln 1-7). Based upon the example of Gottinger, it would have been obvious to one of ordinary skill in the art to embody the coupling member taught by Perthu and incorporated into Imai in the above modification (see in re claim 9) to be a flexible coupling member, as is commonly understood to be suitable within the art for the purpose of coupling an injection delivery device to a holder. Allowable Subject Matter While no rejections over the prior art are presently presented for claims 5-8 and 14 , any indication of allowability regarding these claims is reserved until the respective rejections under 35 U.S.C. 112(a) are overcome. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric A Lange whose telephone number is (571)272-9202. The examiner can normally be reached on M-F 8:30am-noon and 1pm-5:30pm. 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, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ERIC A LANGE/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783 Application/Control Number: 18/293,191 Page 2 Art Unit: 3783 Application/Control Number: 18/293,191 Page 3 Art Unit: 3783 Application/Control Number: 18/293,191 Page 4 Art Unit: 3783 Application/Control Number: 18/293,191 Page 5 Art Unit: 3783 Application/Control Number: 18/293,191 Page 6 Art Unit: 3783 Application/Control Number: 18/293,191 Page 7 Art Unit: 3783 Application/Control Number: 18/293,191 Page 8 Art Unit: 3783 Application/Control Number: 18/293,191 Page 10 Art Unit: 3783 Application/Control Number: 18/293,191 Page 11 Art Unit: 3783 Application/Control Number: 18/293,191 Page 13 Art Unit: 3783 Application/Control Number: 18/293,191 Page 14 Art Unit: 3783 Application/Control Number: 18/293,191 Page 15 Art Unit: 3783 Application/Control Number: 18/293,191 Page 16 Art Unit: 3783 Application/Control Number: 18/293,191 Page 17 Art Unit: 3783 Application/Control Number: 18/293,191 Page 18 Art Unit: 3783 Application/Control Number: 18/293,191 Page 19 Art Unit: 3783 Application/Control Number: 18/293,191 Page 20 Art Unit: 3783 Application/Control Number: 18/293,191 Page 21 Art Unit: 3783 Application/Control Number: 18/293,191 Page 22 Art Unit: 3783 Application/Control Number: 18/293,191 Page 23 Art Unit: 3783
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