DETAILED ACTION
Response to Amendment
This Office action is in response to the amendment filed March 9, 2026. Claims 1, 11, and 20 are amended and claims 31 is newly added. Claims 19 and 30 are canceled. Claims 1-2, 9, 11, 20-23, 29, and 31 are pending and addressed below.
Response to Arguments
In light of the cancellation to claim 30, the drawing objection has been withdrawn.
In light of the amendment to claim 1, the claim object has been withdrawn.
In light of the amendment to claim 11, the rejection under 112(b) has been withdrawn.
However, the amendment to claim 1 to incorporate the limitations of claim 19 has not remedied the 112(b) rejection previously applied to claim 19. Rather, the same 112(b) rejection previously made for claim 19 is now applicable to amended claim 1. The issue is claim 1 recites “a lead receiving element,” which is deformable, thereby “constituting a retaining mechanism.” Examiner reads this claim language as effectively stating the lead receiving element is a retaining mechanism, essentially synonymous for the purpose of claim interpretation. Later in amended claim 1, applicant now claims “the retaining mechanism comprises an embracing member” is effectively read as the lead receiving element “comprises an embracing member” because the lead receiving element constitutes the retaining mechanism. Therefore, the entire limitation of “the retaining mechanism comprises an embracing member embracing at least a portion of said lead receiving element and is capable of selectively [sic] adjustment along a range of embracing pressures on said lead receiving element” creates indefiniteness, because claim 1 is effectively claims that the lead receiving element embraces itself for selectively adjusting pressure along the length of the lead receiving element. Applicant is encouraged to restructure the claim such that the parts properly align. After careful consideration, some suggestions include (1) dropping the use of a retaining mechanism entirely and only relying on the lead receiving element and the embracing member as the claimed features of the device; and (2) defining the retaining mechanism as comprising a lead receiving element and an embracing mechanism prior to claiming the relationship between the lead receiving element and the embracing element. However, applicant should consider the original disclosure in drafting amendments to ensure support. Because any assumptions as to the intended claim language or examination would require substantial overhauling of the claim for examination, no prior art rejection is presented. However, applicant is encouraged to carefully consider Nageri et al. (US 20150045865) in drafting amendments to overcome the 112(b) rejection.
Regarding claim 31, which combines parts of claim 1 with the allowable subject matter of claim 9, it is noted that a substantial portion of previously presented claim 1 has been removed, thus the scope has changed and is not a mere incorporation of allowable subject matter with the independent claim. Furthermore, claim 31 is subject to election by original presentation under the Unity of Invention standard. Please see below for more details.
Election/Restrictions
Newly submitted claim 31 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: under Unity of Invention standard, the common technical feature of the lead receiving element is taught by Nageri et al. (US 20150045865). The Non-Final Rejection issued December 8, 2025, includes citations to Nageri et al. teaching the lead receiving element.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 30 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Objections
Claim 1 is objected to because of the following informalities: in line 16, “selectively adjustment” should read --selective adjustment--. 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 1-2, 9, 11, 20-23, and 29 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.
Claim 1 (lines 8-11) recites “wherein at least a portion of the lead receiving element is deformable upon external application of force thereon, resulting in at least one of
(1) a reduction of at least a portion of the lumen cross section and/or
(2) an increase of pressure on a lead received in the lumen,
thereby constituting a retaining mechanism…”. Claim 1 (line 15) subsequently recites “the retaining mechanism comprises an embracing member embracing at least a portion of said lead receiving element.”
It is unclear if the retaining mechanism is a part of the lead receiving element (as recited in lines 8-11) or if the retaining mechanism is an embracing member that embraces a part of the lead receiving element (as recited in line 15). Furthermore, the figures only show a lead receiving element 120 and do not show an embracing member embracing the lead receiving element, examiner is unclear how to best interpret the claims. It best appears as though a part of the lead receiving element is the embracing member, but that would require examiner to totally rewrite and negate portions of amended claim 1. Therefore, claim 11 will be not examined in light of the prior art.
Claims 2, 9, 11, 20-23, and 29 are rejected under 112(b) as depending from claim 19, and will likewise not be addressed by the prior art.
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 Wade Miles whose telephone number is (571)270-7777. The examiner can normally be reached Monday-Friday 10:00 am - 7:00 pm ET.
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/WADE MILES/Supervisory Patent Examiner, Art Unit 3656
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