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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 3/3/2023 and 1/17/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
New corrected drawing in compliance with 37 CFR 1.121(d) are required in this application. Figures 1, 2A-2B, 3A-3C, 4A-4B, 5A-5B, 6A-6D, and 7-22 contain handwritten text and figures 6A-6D and 10 contain improper shading, which may affect clarity once reproduced. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
The drawings are objected to because figure 7 is illegible. It is unclear what is depicted in figure 7. 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.
Specification
The disclosure is objected to because of the following informalities:
This application claims priority to Provisional Application 63/285, 294 filed 12/2/2021. Examiner suggests amending the specification to include the heading “Cross-Reference to Related Applications” underneath the title and adding in the priority information regarding the provisional application.
Appropriate correction is required.
Claim Objections
Claim 2 objected to because of the following informalities:
Line 3 recites “the range of 5-50 degrees”. As the range has not been previously introduced, Examiner suggests replacing “the range of 5-50 degrees” in line 3 of claim 2 with “a range of 5-50 degrees”.
Claim 4 objected to because of the following informalities:
Line 1-2 recites “the range of 5-15 degrees”. As the range has not been previously introduced, Examiner suggests replacing “the range of 5-15 degrees” in line 1-2 of claim 4 with “a range of 5-15 degrees”.
Claim 16 objected to because of the following informalities:
Line 2 recites “the rotational position”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the rotational position” in line 2 of claim 16 with “a rotational position”.
Claim Rejections - 35 USC § 112
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.
Claims 2, 4, and 23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regard to claim 2,
Line 1-2 recites “an axis including the distal end of the guide and the distal tip of the needle”. Claim 2 depends on claim 1. Claim 1 recites “an axis including the distal end of the guide and the distal tip of the needle”. It is unclear if the axis of claim 2 is intended to be a second axis including the distal end of the guide and the distal tip of the needle, or refer to the axis including the distal end of the guide and the distal tip of the needle of claim 1 or be broad. Appropriate correction is required. For examination purposes Examiner construes claim2 to be broad in that the axis of claim 2 can be the same or different. Examiner suggests replacing “an axis including the distal end of the guide and the distal tip of the needle” with “the axis including the distal end of the guide and the distal tip of the needle” if intending to be the same axis as claim 1.
Examiner notes claim 4 is similarly rejected by virtue of its dependency on claim 2.
In regard to claim 23,
Line 4-5 recites “the needle coupling portion”. Line 2 recites “a second needle coupling portion” and line 2-3 recites “a first needle coupling portion”. It is unclear which coupling portion “the needle coupling portion” of line 4-5 refers to. For examination purposes Examiner construes “the needle coupling portion” to be “the second needle coupling portion”. Examiner suggests replacing “the needle coupling portion” in line 4-5 of claim 23 with “the second needle coupling portion”.
Claim Rejections - 35 USC § 102
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 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)(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.
Claims 1, 5-7, 9-11, 14-18 and 23 are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by Holl (U.S. PG publication 20230149635).
In regard to claim 1,
Holl discloses a device (see figure 1-8, item 1) for subdermal insertion of solid media (paragraph [0001]), the device comprising:
a handle (figure 1, item 2; Examiner notes the housing/handle 2 is made up of item 3, 4, and 9 as disclosed in paragraph [0050]) having a central plane (see figure 1 and 2);
a needle (figure 2, item 11) coupled to and extending from the handle (see figure 2), the needle having a needle longitudinal axis and a distal tip disposed along the needle longitudinal axis and the central plane (see figure 2); and
a guide (figure 2, item 6; paragraph [0043]) extending from the handle (see figure 2), the guide having a distal end disposed along the central plane (see figure 2),
wherein the distal end of the guide is disposed further than the distal tip of the needle from the handle (paragraph [0043]: the length of the penetration guide 6 is longer than the needle), and
wherein the distal tip of the needle is visible when viewed along the central plane and perpendicular to an axis including the distal end of the guide and the distal tip of the needle (see figure 2; paragraph [0044]; Examiner notes the guide is transparent and therefore allows visibility).
In regard to claim 5,
Holl discloses the device of claim 1, wherein the guide defines a window through which the distal tip of the needle is visible (paragraph [0044] and [0048], the guide defines a window through which the distal tip of the needle is visible due to the guide being transparent).
In regard to claim 6,
Holl discloses the device of claim 1, wherein the handle defines a cavity (see figure 5-8) and the needle is retractable into the handle (paragraph [0052]).
In regard to claim 7,
Holl discloses the device of claim 6, wherein the needle is manually retractable (paragraph [0051], manually retractable via item 10).
In regard to claim 9,
Holl discloses the device of claim 6, wherein the handle includes a slider (figure 7, item 10) for causing the needle to move from an extended position to a retracted position (paragraph [0051]).
In regard to claim 10,
Holl discloses the device of claim 6, further including a plunger (figure 5 and 7-8, item 8) axially aligned with the needle longitudinal axis (see figure 7) such that, when the needle is retracted, the plunger extends through the needle (see figure 7).
In regard to claim 11,
Holl discloses the device of claim 6, wherein the needle is lockable in a retracted position (paragraph [0050]-[0051]).
In regard to claim 14,
Holl discloses the device of claim 1, wherein an edge of the distal end of the guide closest to the distal tip of the needle defines a fillet, a chamfer, or an eased edge (paragraph [0047]).
In regard to claim 15,
Holl discloses the device of claim 1, wherein the needle includes a first needle coupling portion (figure 5, item 12) and the handle includes a second needle coupling portion (space formed between guides 14 and 17 in figure 5 which receive item 12; paragraph [0050]) and the first needle coupling portion of the needle is coupled to the second needle coupling portion of the handle (paragraph [0050]).
In regard to claim 16,
Holl discloses the device of claim 15, wherein the needle and the handle include rotational clocking features (figure 5, item 13, 16, 14, and 17) to ensure the rotational position of the needle relative to the handle (paragraph [0050] wherein the needle is secured in place firmly).
In regard to claim 17,
Holl discloses the device of claim 15, wherein the first needle coupling portion is integrally formed with the needle (see figure 5; 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,
Holl discloses 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 (paragraph [0050]).
In regard to claim 23,
Holl discloses a device for subdermal insertion of solid media (see figure 1-8, item 1), the device comprising:
a handle (figure 1, item 2; Examiner notes the housing/handle 2 is made up of item 3, 4, and 9 as disclosed in paragraph [0050]) having a central plane (see figure 2) and a second needle coupling portion (space formed between guides 14 and 17 in figure 5 which receive item 12; paragraph [0050]) for coupling a first needle coupling portion (figure 5, item 12) of a needle (figure 2, item 11; Examiner notes the needle and the first needle coupling portion are not positively required by the claim), the needle having a needle longitudinal axis and a distal tip disposed along the needle longitudinal axis (see figure 2), wherein, when the needle is coupled to the needle coupling portion, the needle extends from the handle such that the distal tip of the needle is disposed along the central plane (see figure 2); and
a guide (figure 2, item 6; paragraph [0043]) extending from the handle (see figure 2), the guide having a distal end disposed along the central plane (see figure 2).
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 2, 4, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Holl (U.S. PG publication 20230149635) further in view of Fischer (WO 2017019631).
In regard to claim 2,
Holl discloses the device of claim 1, wherein an axis including the distal end of the guide and the distal tip of the needle forms an entry angle with the needle longitudinal axis (paragraph [0048]: The shape of the distal end of the penetration guide or second portion of the penetration guide may be configured to prevent extremely steep needle angles relative to the skin from being initiated for initial needle insertion).
Holl is silent as to the entry angle being in the range of 5-50 degrees.
Fischer teaches wherein an axis including the distal end of the guide and the distal tip of the needle forms an entry angle with the needle longitudinal axis (paragraph [0010]), the entry angle being in the range of 5-50 degrees (paragraph [0010]; Examiner notes the entry angle is construed as 15 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 Holl to include the entry angle as 15 degrees which results in the entry angle being in the 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,
Holl in view of Fischer teaches the device of claim 2, wherein the entry angle is in the range of 5-15 degrees (see analysis of claim 2 above and paragraph [0010] of Fischer).
In regard to claim 21,
Holl discloses the device of claim 1, wherein the guide includes a surface that is closest to the needle (see figure 2).
Holl 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 Holl 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,
Holl 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).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Holl (U.S. PG publication 20230149635) further in view of Francavilla (U.S. PG publication 20060276756).
In regard to claim 13,
Holl discloses the device of claim 1.
Holl 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 Holl 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).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Holl (U.S. PG publication 20230149635) further in view of Smith (U.S. PG publication 20160354115).
In regard to claim 19,
Holl discloses 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 2; paragraph [0043]: wherein the width of the guide 6 is wider than the needle).
Holl is silent as to wherein a total width of the at least one surface is 15mm-30mm.
Smith teaches wherein the guide (item 100) includes at least one surface that defines a plane that extends parallel to the needle longitudinal axis (see figure 5A), wherein a total width of the at least one surface is 15mm-30mm (paragraph [0102]; wherein the width is 25 mm which is between 15mm-30mm).
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 Holl to include wherein a total width of the at least one surface is 25 mm which result in wherein a total width of the at least one surface is 15mm-30mm, as taught by Smith, for the purpose of enabling convenient and safe placement of the cannula/needle into tissue (paragraph [0026] of Smith).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Holl (U.S. PG publication 20230149635).
In regard to claim 20,
Holl discloses 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 2; paragraph [0043]: wherein the width of the guide 6 is wider than the needle), wherein a total width of the at least one surface is larger than an outer diameter of the needle (see figure 2; paragraph [0043]: wherein the width of the guide 6 is wider than the needle).
Holl is silent as to wherein a total width of the at least one surface is three or more times larger than an outer diameter of the needle.
It would have been an obvious matter of design choice to modify Holl to include wherein a total width of the at least one surface is three or more times larger than an outer diameter of the needle since the only difference between the prior art and what is claimed is a recitation of relative dimensions of the claimed guide and a 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). As noted above, paragraph [0043] of Holl supports that the width of the guide 6 is wider than the needle.
Additionally, it would have been an obvious matter of design choice to modify Holl to include a total width of the at least one surface is three or more times larger than an outer diameter of the needle since applicant has not disclosed that having a total width of the at least one surface specifically three or more times larger than an outer diameter of the needle (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 a total width of the at least one surface being specifically three or more times larger than an outer diameter of the needle, 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).
Conclusion
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.
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, Kevin Sirmons can be reached at (571) 272-4965. 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.
/ALEXANDRA LALONDE/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783