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 .
Response to Amendment
The Amendment filed on 4/17/2026 has been entered. Claims 1-2, 4-7, 9-11, 13-19, and 21-23 remain pending in the application.
Applicants amendments to the specification have overcome the specification objections previously set forth in the Non-final Office Action mailed 11/17/2025.
Applicants amendments to the claims have overcome the claim objections previously set forth in the Non-final Office Action mailed 11/17/2025.
Applicants amendments to the claims have overcome the rejections under 35 USC 112 previously set forth in the Non-final Office Action mailed 11/17/2025.
Drawings
The drawings are objected to because figure 7 is illegible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
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.
Claims 1-2, 4-7, 9-11, 13-19, and 21-23 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.
In regard to claim 1,
Line 17-18 recites “an entire length of the needle that extends from the handle is visible through the open window”. There is not support in the original disclosure for this limitation. As shown in figure 4B in the instant disclosure, there is a portion of the needle that extends from the handle that is not visible through the open window when viewed along the central plane and perpendicular to the needle longitudinal axis. The disclosure appears to be completely silent regarding an entire length of the needle that extends from the handle is visible through the open window. Appropriate correction is required. Examiner notes support appears to be present for “the distal tip of the needle is visible through the open window”.
Line 20 recites “wherein the window width is at least three times larger than the needle diameter”. There is not support in the original disclosure for this limitation. Paragraph [0013] of the disclosure states “a total width of the at least one surface is three or more times larger than an outer diameter of the needle”. Paragraph [0077] of the disclosure further states the width of the second surface 184 is three or more times larger than the outside diameter of the needle. As shown in figure 1 and 4B, the width of the open window 190 is not the same as the width of the second surface 184. The open window width is less than the width of the second surface. As the figures are not to scale, it is unclear the open window width. Appropriate correction is required.
In regard to claim 23,
Line 13 recites “the window width is at least three times larger than the needle diameter”. There is not support in the original disclosure for this limitation. Paragraph [0013] of the disclosure states “a total width of the at least one surface is three or more times larger than an outer diameter of the needle”. Paragraph [0077] of the disclosure further states the width of the second surface 184 is three or more times larger than the outside diameter of the needle. As shown in figure 1 and 4B, the width of the open window 190 is not the same as the width of the second surface 184. The open window width is less than the width of the second surface. As the figures are not to scale, it is unclear the open window width. Appropriate correction 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.
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.
Claim 5 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 regard to claim 5,
Line 2 recites “the entire length of the needle that extends from the handle therethrough”. It is unclear what structure “therethrough” refers to in claim 5. It is unclear if therethrough refers to through the open window. For examination purposes Examiner construes “therethrough” to be “through the open window”. Additionally, claim 5 depends on claim 1. Claim 1 recites “an entire length of the needle that extends from the handle”. As shown in figure 4B of the disclosure, the entire length of the needle that extends from the handle is different than the entire length of the needle that extends from the handle through the window. Therefore, an entire length of the needle that extends from the handle of claim 1 would not provide antecedent basis for the entire length of the needle that extends from the handle therethrough (through the window) in claim 5. Examiner suggests addressing the 112a issue above in regard to claim 1 and amending claim 5 accordingly.
Claim Rejections - 35 USC § 103
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.
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, 5-7, 9-10, 14-15, 17-19, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (U.S. PG publication 20160354115).
In regard to claim 1,
Smith discloses a device (see all of figure 1A-1B and 4A-4C) for subdermal insertion of solid media (paragraph [0002] and [0004]; Examiner notes “for subdermal insertion of solid media” is a functional limitation. The device is fully capable of the recited function due to its structure. It is noted that solid media is not positively required by the claim), the device comprising:
a handle (figure 1A and 4A-4C, item 120 and 100) defining a central plane (see figure 1A and 4A-4C) and including:
a grip (figure 1A and 4A-4C, item 120; Examiner notes due to the shape of item 120 it is fully capable of being gripped; paragraph [0102]), and
a guide (figure 1A and 4A-4C, item 100) extending from the grip (see figure 1A and 4A-4C) and defining
a guide distal end disposed along the central plane (see figure 1A and 4A-4C), and
an open window (figure 1A, 4A, and 4C, item 110; paragraph [0101]) defining a window width in a direction perpendicular to the central plane (see figure 4A and 4C); and
a needle (figure 1A, item 115) coupled to and extending from the handle (see figure 1A and 4A-4C), the needle defining
a needle longitudinal axis (see figure 1A and 4A-4C),
a distal tip disposed along the needle longitudinal axis and the central plane (see figure 1A and 4A-4C), and
a needle diameter (see figure 1A and 4A-4C),
wherein an entire length of the needle that extends from the handle is visible through the open window when viewed along the central plane and perpendicular to the needle longitudinal axis (see figure 4C and 4A; paragraph [0101]), and
wherein the window width is larger than the needle diameter (see figure 4A and 4C; paragraph [0109]).
Smith is silent as to wherein the window width is at least three times larger than the needle diameter.
It would have been an obvious matter of design choice to modify Smith to include wherein the window width is at least three times larger than the needle diameter since the only difference between the prior art and what is claimed is a recitation of relative dimensions of the claimed open window of the guide and an open window of the guide having the claimed relative dimensions would not perform differently than the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Additionally, it would have been an obvious matter of design choice to modify Smith to include wherein the window width is at least three times larger than the needle diameter since applicant has not disclosed that having wherein the window width is at least three times larger than the needle diameter (rather than .5 times larger or 1.5 times larger or two times larger or five times larger for example) solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of wherein the window width is at least three times larger than the needle diameter, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
In regard to claim 5,
Smith teaches the device of claim 1, wherein the open window allows visual access to the entire length of the needle that extends from the handle therethrough (paragraph [0101]; see figure 4C).
In regard to claim 6,
Smith teaches the device of claim 1, wherein the handle defines a cavity (see figure 1B) and the needle is retractable into the handle (paragraph [0111]).
In regard to claim 7,
Smith teaches the device of claim 6, wherein the needle is manually retractable (paragraph [0111]).
In regard to claim 9,
Smith teaches the device of claim 6, wherein the handle includes a slider (figure 1B, item 130a) for causing the needle to move from an extended position to a retracted position (paragraph [0111]).
In regard to claim 10,
Smith teaches the device of claim 6, further including a plunger (figure 1B, item 125) axially aligned with the needle longitudinal axis such that, when the needle is retracted, the plunger extends through the needle (paragraph [0111]).
In regard to claim 14,
Smith teaches the device of claim 1, wherein an edge of the guide distal end closest to the distal tip of the needle defines a fillet, a chamfer, or an eased edge (fillet; see figure 4B).
In regard to claim 15,
Smith teaches the device of claim 1, wherein the needle includes a first needle coupling portion (figure 1B, item 130B) and the handle includes a second needle coupling portion (item 130a; paragraph [0111]) the first needle coupling portion of the needle is coupled to the second needle coupling portion of the handle (paragraph [0111]).
In regard to claim 17,
Smith teaches the device of claim 15, wherein the first needle coupling portion is integrally formed with the needle (see figure 1B; Examiner notes the first needle coupling portion is integrally formed with the needle as the first needle coupling portion and needle form an integral structure when attached).
In regard to claim 18,
Smith teaches the device of claim 15, wherein the needle is preloaded with one or more pellets, rods, capsules, cylinders, spheres, implants, sensors, or any combination thereof (implant; paragraph [0006]-[0009] and [0111]).
In regard to claim 19,
Smith teaches the device of claim 1, wherein the guide includes at least one surface that defines a plane that extends parallel to the needle longitudinal axis (see figure 4A), wherein a total width of the at least one surface is 15mm-30mm (paragraph [0102]; wherein the width is construed as 25 mm which is between 15mm-30mm).
In regard to claim 23,
Smith discloses a device (see all of figure 1A-1B and 4A-4C) for subdermal insertion of solid media (paragraph [0002] and [0004]; Examiner notes “for subdermal insertion of solid media” is a functional limitation. The device is fully capable of the recited function due to its structure. It is noted that solid media is not positively required by the claim), the device comprising:
a handle (figure 1A and 4A-4C, item 120) having a central plane (see figure 1A and 4A-4C) and a handle coupling portion (figure 1B, item 130A) configured to engage a needle coupling portion (figure 1B, item 130B) of a needle (figure 1B and 4A-4C, item 115; Examiner notes “configured to engage a needle coupling portion of a needle” is a functional limitation. The handle coupling portion is fully capable of the intended function due to its structure; see paragraph [0111]; Examiner notes The needle and needle coupling portion are not positively required by the claim), the needle having a needle longitudinal axis (see figure 1B and 4A-4C), a distal tip disposed along the needle longitudinal axis (see figure 1B and 4A-4C), and a needle diameter (see figure 1B and 4A-4C; As noted above the needle is not positively required by the claim and therefore “the needle having a needle longitudinal axis, a distal tip disposed along the needle longitudinal axis, and a needle diameter” is also not positively required by the claim),
wherein, when the needle coupling portion is coupled to the handle coupling portion, the needle extends from the handle such that the distal tip of the needle is disposed along the central plane (see figure 4A-4C; paragraph [0111]); and
a guide (figure 1A and 4A-4C, item 100) formed with and extending from the handle (see figure 1A and 4A-4C; Examiner notes the guide is formed with the handle as shown in figure 4A-4C as the guide and handle have been formed and attached to one another), the guide defining
a guide distal end disposed along the central plane (see figure 4A-4C), and
an open window (figure 1A, 4A, and 4C, item 110; paragraph [0101]) defining a window width in a direction perpendicular to the central plane (see figure 1A, 4A, and 4C), the window width is larger than the needle diameter (see figure 4A and 4C; paragraph [0109]; As noted above, the needle is not positively required by the claim and the device would be capable of use with needles have different diameters).
Smith is silent as to the window width is at least three times larger than the needle diameter.
It would have been an obvious matter of design choice to modify Smith to include the window width is at least three times larger than the needle diameter since the only difference between the prior art and what is claimed is a recitation of relative dimensions of the claimed open window of the guide and an open window of the guide having the claimed relative dimensions would not perform differently than the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Additionally, it would have been an obvious matter of design choice to modify Smith to include the window width is at least three times larger than the needle diameter since applicant has not disclosed that having the window width is at least three times larger than the needle diameter (rather than .5 times larger or 1.5 times larger or two times larger or five times larger for example) solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of the window width is at least three times larger than the needle diameter, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). As noted above, the needle is not positively required by the claim. The device would be capable due to its structure of use with a needle in which the window width is at least three times larger than the needle diameter.
Claims 2, 4, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (U.S. PG publication 20160354115) further in view of Fischer (WO 2017019631).
In regard to claim 2,
Smith teaches the device of claim 1, wherein an axis intersecting the guide distal end and the distal tip of the needle forms an entry angle with the needle longitudinal axis (see figure 4B).
Smith is silent as to the entry angle being in a range of 5-50 degrees.
Fischer teaches wherein an axis intersecting the guide distal end and the distal tip of the needle forms an entry angle with the needle longitudinal axis (paragraph [0010]), the entry angle being in a range of 5-50 degrees (paragraph [0010]; Examiner notes the entry angle is construed as 15-45 which is in the range of 5-50 degrees).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Smith to include the entry angle being in a range of 5-50 degrees, as taught by Fischer, for the purpose of ensuring the cannula is positioned at a preferred angle relative to the skin to insert an implant correctly (paragraph [0036] of Fischer).
In regard to claim 4,
Smith in view of Fischer teaches the device of claim 2, wherein the entry angle is in a range of 15-45 degrees (see analysis of claim 2 above and paragraph [0010] of Fischer).
In regard to claim 21,
Smith teaches the device of claim 1, wherein the guide includes a surface that is closest to the needle (see figure 4B).
Smith is silent as to wherein a distance from the surface of the guide to the needle is 3mm-15mm.
Fischer teaches wherein the guide (figure 1B, item 103) includes a surface that is closest to the needle (figure 1B, item 101), wherein a distance from the surface of the guide to the needle is 3mm-15mm (paragraph [0040] wherein the guide 101 is construed as being .3 inches above the cannula which is 7.62 mm).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Smith to include a distance from the surface of the guide to the needle is 7.62 mm which results in a distance from the surface of the guide to the needle is 3mm-15mm, as taught by Fischer, for the purpose of ensuring an implant is inserted correctly (paragraph [0036] of Fischer).
In regard to claim 22,
Smith in view of Fischer teaches the device of claim 21, wherein the distance from the surface of the guide to the needle is 5mm-10mm (see analysis of claim 21 above).
Claims 11 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (U.S. PG publication 20160354115) further in view of Holl (U.S. PG publication 20230149635).
In regard to claim 11,
Smith teaches the device of claim 6.
Smith is silent as to wherein the needle is lockable in a retracted position.
Holl teaches wherein the needle (figure 5, item 11) is lockable in a retracted position (paragraph [0050]-[0051]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Smith to include wherein the needle is lockable in a retracted position, as taught by Holl, for the purpose of providing a means to ensure that the needle is fully retracted and made safe within the housing after the administration procedure to prevent accidental needle sticks injury to users (paragraph [0051] of Holl).
In regard to claim 16,
Smith teaches the device of claim 15, wherein a rotational position of the needle relative to the handle is ensured (a rotational position of the needle relative to item 120 of the handle is ensured; paragraph [0100] wherein item 120 and the needle are rotationally fixed relative to each other).
Smith is silent as to wherein the needle and the handle include rotational clocking features to ensure a rotational position of the needle relative to the handle.
Holl teaches wherein the needle and the handle include rotational clocking features (figure 5, item 13, 16, 14, and 17) to ensure a rotational position of the needle relative to the handle (paragraph [0050] wherein the needle is secured in place firmly).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Smith to include wherein the needle and the handle include rotational clocking features to ensure a rotational position of the needle relative to the handle, as taught by Holl, for the purpose of securing the needle in place during insertion and allowing the needle to slide (paragraph [0050] of Holl).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Smith (U.S. PG publication 20160354115) further in view of Francavilla (U.S. PG publication 20060276756).
In regard to claim 13,
Smith teaches the device of claim 1.
Smith is silent as to wherein the handle has an hourglass shape as viewed in a direction parallel to the central plane.
Francavilla teaches wherein the handle (figure 2, item 210) has an hourglass shape as viewed in a direction parallel to the central plane (paragraph [0028]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Smith to include wherein the handle has an hourglass shape as viewed in a direction parallel to the central plane, as taught by Francavilla, for the purpose of accommodating a user’s hand (paragraph [0028] of Francavilla).
Response to Arguments
Applicant’s arguments filed 4/17/2026 regarding shading and handwritten text filed in the drawings have been fully considered and are persuasive. The drawing objections regarding shading and handwritten text have been withdrawn.
Applicant's arguments filed 4/17/2026 regarding figure 7 being illegible have been fully considered but they are not persuasive. Applicant references paragraph [0070] of the disclosure and states “The varying length and diameters of needles 160 are very clearly legible”. As reproduced below, Figure 7 contains very light lines and the specific portions boxed by the Examiner appear to say something, but it is unclear and therefore the figure is illegible. Examiner agrees that paragraph [0070] describes figure 7. However, figure 7 is unclear and illegible due to portions of figure 7 being unable to be read and interpreted.
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Applicant’s arguments with respect to Holl (U.S. PG publication 20230149635) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues in regard to Smith (U.S. PG publication 20160354115) that the placement guide 100 is not part of the handle and is specifically designed to rotate relative thereto. Examiner notes claim 1 and 23 do not require the guide to be rotationally locked relative to the handle and therefore Applicant’s arguments are not found to be persuasive. Further, claim 1 as currently claimed, requires the handle to have two different parts (grip and guide) and claim 23 requires the handle and the guide to be separate structures.
Applicant argues that the opening 110 of Smith is not at least three times larger than the needle diameter. As noted above, it would have been an obvious matter of design choice to modify Smith to include wherein the window width is at least three times larger than the needle diameter since the only difference between the prior art and what is claimed is a recitation of relative dimensions of the claimed open window of the guide and an open window of the guide having the claimed relative dimensions would not perform differently than the prior art device. Additionally as noted above, it would have been an obvious matter of design choice to modify Smith to include wherein the window width is at least three times larger than the needle diameter since applicant has not disclosed that having wherein the window width is at least three times larger than the needle diameter (rather than .5 times larger or 1.5 times larger or two times larger or five times larger for example) solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. No arguments have been provided regarding the size of the window width being a design choice.
Although the claims are not currently rejected over Holl in view of Smith, it is noted that the open window 110 of Smith appears to be a feature that could be incorporated into the guide (item 6) of Holl. Regardless of whether the needle can rotate relative to the guide of Smith, having an open window provides a distinct benefit of “allowing the practitioner to touch, through visualization opening 110, skin above the entire inserted length of the cannula, to confirm proper placement of the cannula/implant to a determined placement depth” as supported by paragraph [0101] of Smith. Therefore, one of ordinary skill in the art would be motivated to modify the window of Holl to be an open window in view of the teachings of Smith.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
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/ALEXANDRA LALONDE/Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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