Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 11 is objected to because of the following informalities: “when then set screw” in line 4 should read “when the set screw”. Appropriate correction is required.
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.
Claim 7 is 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 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 inventors, at the time the application was filed, had possession of the claimed invention. The specification does not provide any definition for what an “atraumatic shape” is. The plain meaning of “atraumatic” is something that is designed to minimize tissue damage. According to the specification and broadest reasonable interpretation, an “atraumatic shape” of the stop shoulder would be one that does not damage the connector. A shape that does not damage the connector could be numerous types of shapes. It is recommended that the applicant further specify in the claim what shape the stop shoulder possesses.
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 7, 11-12, and 15 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. It is unclear what an “atraumatic shape” is in light of the plain meaning and specification. It is also unclear how a locking element or stop shoulder are “atraumatic”. For examination purposes, the examiner interpreted “atraumatic shape” as any shape that does not damage tissue, and “atraumatic locking element” and “atraumatic stop shoulder” as any locking element or stop shoulder that doesn’t have protrusions into tissue.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McSweeney et al. (U.S. PGPub No. 2018/0036462).
Regarding claim 1, McSweeney teaches a locking mechanism (Fig. 1A-1B, paragraph 0039, lines 1-2) for a connector (Paragraph 0041, lines 1-2) to an implantable controller (Fig. 16, paragraph 0090, line 3), comprising: a housing (Fig. 6A, paragraph 0050, line 6) of the implantable controller defining a housing bore (Fig. 6A, paragraph 0050, lines 1-2) sized to receive the connector (Paragraph 0050, lines 9-11); and a set screw (Fig. 4, paragraph 0061, line 4) releasably coupled to the housing (Fig. 9A-9B, paragraph 0084, lines 1-4) and disposed at an oblique angle with respect to the housing (Paragraph 0084, lines 4-6), the set screw being configured to engage at least a portion of the connector (Paragraph 0072, lines 1-2) when the set screw is fully inserted within the housing (Fig. 10C) to lock the connector within the housing (Paragraph 0072, lines 8-13).
The examiner would like to note that although McSweeney does not explicitly teach that the set screw is disposed at an oblique angle with respect to the housing, McSweeney discloses that “the locking element may move in other directions, such as directions parallel to the axis” [0084]. It would be well known by a person of ordinary skill in the art that an oblique angle is any angle that is not a right angle (90°) or a multiple of a right angle (180°, 270°, etc.). Furthermore, it would be understood that if the set screw were disposed in a direction parallel to the axis, it would be at a 0° angle, which qualifies as an oblique angle.
Regarding claim 2, McSweeney teaches the mechanism (Fig. 1A-1B, paragraph 0039, lines 1-2) of claim 1, wherein the set screw (Fig. 4, paragraph 0061, line 4) is configured to engage a flange (Paragraph 0072, lines 4-8) of a distal end (Fig. 4, paragraph 0070, lines 14-16) of the connector (Paragraph 0041, lines 1-2) when fully inserted within the housing (Fig. 10C).
Regarding claim 3, McSweeney teaches the mechanism (Fig. 1A-1B, paragraph 0039, lines 1-2) of claim 2, wherein the housing bore (Fig. 6A, paragraph 0050, lines 1-2) tapers in diameter as it extends distally (Paragraph 0041, lines 3-4 and paragraph 0050, lines 12-14).
The examiner would like to note that although McSweeney does not explicitly teach that the housing bore tapers in diameter as it extends distally, McSweeney discloses that “the shaft contact 30 and the bore contact 70 may assume any number of geometric forms” [0050]. It would be well known by a person of ordinary skill in the art that the housing bore could include a geometry that tapers in diameter as it extends distally, as the connector being inserted into the housing bore can have any geometry, and McSweeney teaches that the bore reflects the connector geometry.
Regarding claim 4, McSweeney teaches the mechanism (Fig. 1A-1B, paragraph 0039, lines 1-2) of claim 3, wherein the set screw (Fig. 4, paragraph 0061, line 4) includes a proximal portion (Fig. 10A-10C) and a distal portion (Fig. 10A-10C), and wherein the proximal portion includes a plurality of threads (Fig. 9-10, paragraph 0061, lines 4-5) and the distal portion includes an elongate rod (Fig. 9A-9C).
Regarding claim 5, McSweeney teaches the mechanism (Fig. 1A-1B, paragraph 0039, lines 1-2) of claim 4, wherein the elongate rod (Fig. 9A-9C) includes a proximal end (Fig. 10A-10C) and a distal end (Fig. 10A-10C), and wherein the distal end includes a stop shoulder (Fig. 10A-10C, paragraph 0061, line 5), and wherein the distal end is configured to engage the flange when the set screw is fully inserted within the housing (Fig. 10C, paragraph 0072, lines 13-18).
Regarding claim 6, McSweeney teaches the mechanism (Fig. 1A-1B, paragraph 0039, lines 1-2) of claim 5, wherein the proximal end (Fig. 10A-10C) of the elongate rod (Fig. 9A-9C) includes a shoulder (Fig. 9A-9B), and wherein the shoulder is configured to engaged a corresponding depth stop (Fig. 9A-9B) defined by the housing.
Regarding claim 7, McSweeney teaches the mechanism (Fig. 1A-1B, paragraph 0039, lines 1-2) of claim 6, wherein the stop shoulder (Fig. 10A-10C, paragraph 0061, line 5) is atraumatic in shape. Because the stop shoulder is not engaging with or having any protrusions into tissue, it is understood that the stop shoulder is atraumatic in shape.
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.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over McSweeney et al. (U.S. PGPub No. 2018/0036462) as applied to claim 1 above, and further in view of Matityahu et al. (U.S. PGPub 2014/0330274).
Regarding claim 11, McSweeney teaches the mechanism (Fig. 1A-1B, paragraph
0039, lines 1-2) of claim 1 that includes the set screw (Fig. 4, paragraph 0061, line 4) and the connector (Paragraph 0041, lines 1-2). McSweeney does not teach that the mechanism further comprises an atraumatic locking element, wherein the set screw is configured to engage the atraumatic locking element, and wherein the atraumatic locking element is pushed into contact with the connector when then set screw is fully inserted.
Matityahu, however, teaches an implantable device with a pivotable fastener and self-adjusting set screw, wherein the device includes an atraumatic locking element (Fig. 82-83, paragraph 0152, lines 1-3). Matityahu further teaches that the set screw (Fig. 82-83, paragraph 0154, lines 1-2) is configured to engage the atraumatic locking element (Paragraph 0156, lines 1-3 and paragraph 0157 lines 1-2), and wherein the atraumatic locking element is pushed into contact with the connector when then set screw is fully inserted (Paragraph 0160, lines 1-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify McSweeney to incorporate the teachings of Matityahu to include an atraumatic locking element, wherein the set screw is configured to engage the atraumatic locking element, and wherein the atraumatic locking element is pushed into contact with the connector when then set screw is fully inserted. Doing so would ensure that there is an alternative component that the set screw can engage with to limit or hinder the movement of the connector when the set screw is fully inserted, as recognized by Matityahu.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 13 would be allowable for disclosing a locking mechanism for a connector to an implantable controller, comprising: a housing of the implantable controller defining a housing bore sized to receive the connector, the housing bore defining a diameter that tapers as it extends distally; a set screw releasably coupled to the housing and disposed at an oblique angle with respect to the housing, the set screw being configured to engage a flange of the connector when the set screw is fully inserted within the housing to lock the connector within the housing; and a retainer pin releasably retained within the housing, the retainer pin being configured to prevent the set screw from being removed when the set screw is fully retracted. McSweeney does not disclose a retainer pin retained within the housing as further defined in the above claim, and thus this claim would be allowable.
Claims 14 and 16-19 would be allowable because they depend on claim 13.
Claims 8-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 8 would be allowable for disclosing the mechanism of claim 1, further
including a retainer pin retained within the housing, the retainer pin being configured to prevent the set screw from being removed when the set screw is fully retracted. McSweeney does not disclose a retainer pin retained within the housing as further defined in the above claim, and thus this claim would be allowable.
Claim 9 would be allowable for disclosing the mechanism of claim 8, wherein the retainer pin is disposed at an angle orthogonal to the set screw. McSweeney does not disclose a retainer pin retained within the housing as further defined in the above claim, and thus this claim would be allowable.
Claim 10 would be allowable for disclosing the mechanism of claim 9, wherein the retainer pin is disposed at an oblique angle with respect to the housing. McSweeney does not disclose a retainer pin retained within the housing as further defined in the above claim, and thus this claim would be allowable.
Claim 15 would be allowable if rewritten or amended to overcome the rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claim 15 would be allowable for disclosing a locking mechanism for a connector to an implantable controller, comprising: a housing of the implantable controller defining a housing bore sized to receive the connector, the housing bore defining a diameter that tapers as it extends distally; a set screw releasably coupled to the housing and disposed at an oblique angle with respect to the housing, the set screw being configured to engage a flange of the connector when the set screw is fully inserted within the housing to lock the connector within the housing, the set screw includes a proximal portion and a distal portion, and wherein the proximal portion includes a plurality of threads and the distal portion includes an elongate rod, the elongate rod includes a proximal end and a distal end, and wherein the distal end includes an atraumatic stop shoulder, and wherein the stop shoulder is configured to engage the flange when the set screw is fully inserted within the housing, the proximal end of the elongate rod further includes a chamfered shoulder, and the chamfered shoulder is configured to engaged a corresponding depth stop defined by the housing; and a retainer pin releasably retained within the housing and disposed at an oblique angle with respect to the housing and orthogonally disposed with respect to the set screw, the retainer pin being configured to prevent the set screw from being removed when the set screw is fully retracted. McSweeney does not disclose a retainer pin retained within the housing as further defined in the above claim, and thus this claim would be allowable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: U.S. PGPub No. 2015/0364861, WIPO Pub. No. 2016/086083, U.S. Patent No. 7,308,312, and U.S. Patent No. 4,934,366.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Heidi Hilsmier whose telephone number is (571)272-2984. The examiner can normally be reached Monday - Fridays from 7:30 AM - 3:30 PM.
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, Carl Layno can be reached at 571-272-4949. 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.
/H.A.H./Patent Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796