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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore:
The cut extending in a direction normal to the longitudinal axis of the lead of claims 3 and 14
The biasing member of claims 4 and 16
The spring, the elastomeric member, the combination of claim 5
The ledge of claim 20
must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
In Figure 1, item 127
In Figure 2, item 63 (should 63 be 68?)
In Figures 3, item 37
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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:
In paragraph [0036] line 7, the phrase “second end 15” should be replaced with “second end 17”.
The paragraphs on page 13 are confusing in light of paragraph [0042] in that page 13 appears to utilize different names for structures introduced in paragraph [0042]. For example, 36 is a chamber in paragraph [0042] and a well-liked region on page 13. Paragraph [0048] uses the term “cardiac lead”. Is this the same as the medical lead assembly? Paragraph [0042] uses the terms connector pin for 52 and then uses the term connector for 52 and page 13 uses cylindrical lead connector for 52. All limitations need to utilize the same name through. Paragraph [0042] port 54 with wall 50 and then discusses a port opening 41 has a wall 50 but makes no mention of port 54. As written, two different items have wall 50 which is confusing. The entire Detailed Description needs to be reviewed and all issues corrected.
In paragraph [0046] line 4, should the phrase “region 68” be replaced with “region 63”. The number 63 is used in Figure 2 but there does not appear to be a “68” in any Figure.
In paragraph [0046] line 5, the phrase “tool 20” should be replaced with “tool 10”.
In paragraph [0046] line 10, the phrase “surfaces 66, 68” should be replaced with “surfaces 60, 64”. Items 66 and 68 are not previously disclosed as surfaces.
In paragraph [0048] line 4, the phrase “hypotube 50” should be replaced with “hypotube 35”.
In paragraph [0050] line 9, the phrase “cutting implement 43” should be replaced with “cutting implement 42”.
In paragraph [0051] line 1, the phrase “directed towards the first end 15 of the second arm” is unclear and does not appear to be true as the specification previously discloses the blade is directed towards the first end 11 of the first arm 12.
In paragraph [0053] line 1, the phrase “FIGS. 4-5” is unclear. The paragraph is basically discussing port 54 which is not shown in Figure 5. Should the phrase be “FIGS. 3 and 4”?
The detailed description of the specification needs to utilize all of the terminology utilized in the claims so it is clear each limitation is supported. For example, the ledge in claim 20.
Appropriate correction is required.
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 1-20 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.
With regards to claims 1 and 2, the phrase “first arm and the second arm are connected to each other” is unclear. As written, the first ends of the arms do not play a role in the connection between the arm which is not supported. Since the ends of the arms are claimed, they must be utilized in this limitation because this is the only way there is support. The phrase should be replaced with “the first end of the first arm and the first end of the second arm are connected to each other”.
With regards to claim 1, the phrase “an open position and a closed position” are unclear. The arms can be in a multiple different positions that would be between the fully open position and a fully closed position and each of these many different positions can be considered an open or a closed position. Further definition utilizing claimed structures is needed. For example, the open position can be defined as when the second ends are furthest apart and the closed position can be defined as when the second end are closest together. Claims 14 and 15 have the same issue.
With regards to claim 1, the phrase “the first arm and the second arm comprise opposed first mating portions and second mating portions” is unclear. As written, the first arm has first and second mating portions (plural) and the second arm has first and second mating portions (plural) which does not appear to be supported (see paragraph [0040] of the specification). The phrase needs to be written so it is clear the first arm has the first mating portion and the second arm has the second mating portion. Claims 6 and 15 have the same issue.
With regards to claim 1, the phrase “when the first end of the first arm and the first end of the second arm are in the closed position” is unclear. Earlier claim 1 discloses the arms move between the positions but there is no mention of the first ends. Also, the specification defines the first ends as 11 and 15 which are connected to each other. Should the open and closed position be defined using the second ends of the arms?
With regards to claim 1, the phrase “implement comprises a cutting blade” is unclear. The implement is a blade and it is unclear how disclosing that it comprises a blade further limits the implement. Was the phrase supposed to disclose a “cutting edge”? Claim 15 has the same issue.
With regards to claim 1, it is unclear how moving the apparatus from the open position to the closed position allows the cutting blade to be configured to form a slit. The movement to the closed position does not allow for the slit to be formed as it is the movement of the apparatus relative to the work piece in the mating portions or the work piece in the mating portions relative to the apparatus that forms the slit as the work piece engages the blade. The apparatus is capable of moving the closed position while having the work piece in the mating portions and no slit be formed.
With regards to claim 2, the hinge disclosure is unclear. Claim 1 discloses the arms are connected and the hinge does not reference back to the claim 1 limitation. Therefore, as written, the hinge is in addition to the arm connection which is not supported. The hinge needs to be disclosed in a way where it defines the arm connection of claim 1. Also, the specification discloses the first ends are the ends with the hinge. This adds to the confusion and the claims should use the same terminology as the specification. It is requested that claims 1 and 2 use the same “end” terminology as the specification.
With regards to claim 2, claim 1 discloses the arms are connected in a way that does not utilize the ends. How can unconnected arms not define the hinge. Claim 1 needs to disclose the ends are connected and then claim 2 can further define the ends as defining a hinge.
With regards to claim 3, claim 1 discloses using a cutting blade to form a slit. As written, the work piece is cut using the annular cutting edge at the same time as the slit is being formed which does not appear to be supported. Claim 3 needs to be clear that the work piece is not in the mating portion of claim 1 and is now interacting with the annular cutting edge after entering the port. Claim 14 has the same issue as it discloses the slit forming function and the annular cutting edge cutting appears to be a continuation of the slit forming rather than a second cutting function as supported by the specification.
With regards to claim 3, it is unclear how the cut formed by the annular cutting edge is normal to the longitudinal axis of the lead. Claim 14 has the same issue.
With regards to claims 4, 5, and 16, the biasing member is unclear. The specification fails to provide any structural insight of the biasing member or the structure of the apparatus that allows for the apparatus to engage and therefore comprise the biasing member.
With regards to claim 6, portions further comprising portions is confusing and unclear. It is recommended that the mating portion disclosures be replaced with “mating surface” that corresponds with the specification. Claims 11 and 17 have the same issue.
With regards to claim 6, the portions being “shaped to retain” the end of the lead is indefinite. Applicant is attempting to further define the portions with the unclaimed indefinite work piece. The term “shaped to retain” makes the portions dependent upon the lead and needs to be removed.
With regards to claim 14, What structure incorporates the hinge. As written, the hinge is in addition to the arms of the tool which is not supported.
With regards to claim 19, claim 19 depends from itself. It is believed that claim 19 was intended to depend from claim 18 in light of the language used. Claim 19 will be treated as being dependent off of claim 18 for this Office action only.
With regards to claim 20, what structure defines the ledge.
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, 2, 6, 8-13, and 15, are rejected, as best understood, under 35 U.S.C. 102(a)(1) as being anticipated by Daggett et al. (8,353,107). It is noted that the language from claims 1, 2, 6, and 8-13 has been utilized in the rejection below.
With regards to claims 1 and 15, Daggett et al. disclose the same invention including an apparatus for removing a component on a proximal end of a workpiece (10) including a first arm (14a) and a second arm (14b), the first arm and the second arm each have a first end and a second end (Figs. 1 and 2), the first arm (14a) and the second arm (14b) are connected to each other (12) and move in opposite to each other between an open position (Fig. 2) and a closed position (Fig. 1), the first arm and the second arm have opposed first mating portions and second mating portions configured to retain the proximal end of the work piece when the first ends are in the closed position (20), an elongated cutting implement (30) enclosed within the second arm (18, 28a, 28b), the cutting implement has a cutting blade (30, 26) oriented at an angle such that when the first ends are moved from the open position to the closed position the blade is configured to form a slit in a portion of the work piece (Fig. 5), and the slit extend along a longitudinal axis of the work piece (Fig. 5).
With regards to claim 2, 6, and 8-13, Daggett et al. include the second arms being connected to form a hinge (12), the arms move about the hinge such that the arms pivot in opposition to move the ends between the open and closed positions (Figs 1 and 2), the mating portions have opposed first and second recessed portions (20), the recessed portions are shaped to retain the proximal end of the work piece when the first ends are in the closed position (20), the first arm has a first external surface with a first grip portion capable of engaging a finger (Figs. 1, 5, and 6), the first grip portion has a substantially arcuate shape (Figs. 1, 5, and 6), the second arm has a second external surface with a second grip portion capable of engaging a thumb (Figs. 1, 5, and 6), the second grip portion has a wall with a first portion and an angled second portion (Figs. 1, 5, and 6), the portions of the wall are substantially planar (Figs. 1, 5, and 6), and the first and second grip portions has a surface texture (Figs. 1, 5, and 6, all surfaces have a texture).
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.
Claims 4, 5, and 16 are rejected, as best understood, under 35 U.S.C. 103 as being unpatentable over Daggett et al. (8,353,107) in view of Blackwell et al. (9,184,575).
With regards to claims 4, 5, and 16, Daggett et al. disclose the invention but fails to disclose a spring between the arms.
Blackwell et al. teach it is known in the art of cutters to incorporate a spring between the arms (134, column 4 lines 15-33). Such a modification allows for the apparatus to remain in the open or closed position (column 4 lines 15-33). Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to have provided Daggett et al. with the spring, as taught by Blackwell et al., because all claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective function and the combination would have yielded predictable results.
Allowable Subject Matter
Claims 14 and 17-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claim 3 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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: none of the prior incorporates the tool with first and second arms, a cutting implement in the second arm cooperating with the mating portions to form the claimed slit and a hypotube with an annular cutting edge in the second arm performing the claimed cut.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON DANIEL PRONE whose telephone number is (571)272-4513. The examiner can normally be reached Monday-Friday: 7:00 am-3:00 pm.
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18 May 2026
/Jason Daniel Prone/Primary Examiner, Art Unit 3724
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