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 Preliminary Amendments
The amendments filed on 27MAY2025 have been considered and are accepted. Accordingly:
Claims 2-21 are currently pending;
Claim 1 has been canceled;
Claims 2-21 have been added.
Therefore, claims 2-21 are currently under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08JUL2025; 18NOV2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
¶0044
¶0044 states “user interface 101”. This should be user interface 102 to have consistent terminology.
¶0048
¶0048 states “sheath 203”. This should be sheath 103 to have consistent terminology.
¶0058
¶0058 states “sheath 203”. This should be sheath 103 to have consistent terminology.
¶0058 states “target region 702”. This should be target region 202 to have consistent terminology.
¶0067
¶0067 states “Ends 1139”. This should be locking member 1139 to have consistent terminology.
¶0070
¶0070 states “primary actuator section 1133”. This should be primary actuator section 1113 to have consistent terminology.
¶0083
¶0083 states “primary electrode 209”. This should be primary electrode 207 to have consistent terminology.
¶0083 states “distal end 207”. This should be distal end 209 to have consistent terminology.
¶0090
¶0090 states “coupling 150”. This should be coupler 150 to have consistent terminology.
¶0096
¶0096 states “user interface 2202”. This should be Guide sleeve 2202 or user interface 102 to have consistent terminology.
¶0102
¶0102 states “outer width 2795 of the device interface 2795”. Part numbers cannot be shared if they are describing separate item.
¶0103
¶0103 states “lock plate 2720”. This should be locking body 2720 to have consistent terminology.
¶0105
¶0105 states “lock plate 2720”. This should be locking body 2720 to have consistent terminology.
¶0105 states “linkage 2718 and channel 2728”. This should be linkage 2728 and channel 2778 to have consistent terminology.
¶0106
¶0106 states “first indicator tab 2718”. This should be channel 2718 to have consistent terminology.
¶0106 states “second indicator tab 2728”. This should be linkage 2728 to have consistent terminology.
¶0107
¶0107 states “slidable locking mechanism 2710”. This should be slidable mounting mechanism 2710 to have consistent terminology.
¶0107 states “retainer ring 2730”. This should be retaining ring 2730 to have consistent terminology.
¶0108
¶0108 states “slidable locking mechanism 2710”. This should be slidable mounting mechanism 2710 to have consistent terminology.
¶0111
¶0111 states “locking body 2722”. This should be base plate 2722 to have consistent terminology.
¶0111 states “locking plate 2722”. This should be base plate 2722 to have consistent terminology.
¶0112
¶0112 states “flange 2752”. This should be interface 2752 to have consistent terminology.
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
Reference character “102” in Figure 1 has been used to designate multiple components.
Reference character “612” in Figure 9 has been used to designate multiple components.
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. 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 because:
Figure 8 appears to have reference numbers 150, 604, & 102 all pointing to the same area.
Figure 9 appears to have reference numbers 150, 604, & 102 all pointing to the same area.
Figure 12A appears to have reference numbers 604 & 102 pointing to the same area.
Figure 13A appears to have reference numbers 604 & 102 pointing to the same area.
Figure 14A appears to have reference numbers 604 & 102 pointing to the same area.
Figure 15A appears to have reference numbers 604 & 102 pointing to the same area.
Figure 16A appears to have reference numbers 604 & 102 pointing to the same area.
Figure 17A appears to have reference numbers 604 & 102 pointing to the same area.
Figure 18A appears to have reference numbers 604 & 102 pointing to the same area.
Figure 19A appears to have reference numbers 604 & 102 pointing to the same area.
Figure 20A appears to have reference numbers 604 & 102 pointing to the same area.
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:
Part 1008 as shown in Figure 10 is not found in the Specification.
Part 2750 as shown in Figure 27 is not found in the Specification.
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.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“Secondary Actuator” found in Claims 2-3, 6, 13, 16, & 20;
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Claim limitation “Secondary actuator”, has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because they use a generic placeholder “actuator” coupled with functional language without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier. A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation. Though the “secondary actuator” is described in paragraphs such as ¶0012 of the Specification which states “A secondary actuator is operably coupled with the secondary electrode and rotatably received within the guide of the primary actuator. The secondary actuator supports the guide member that is configured to engage the helical path. The secondary actuator is rotatable relative to the primary actuator to motivate the secondary electrode to move relative to the primary electrode.”, no specific device is named for the secondary actuator. The specification only functionally describes the part without disclosing whether this actuator may represent items such as a motor, belt, spring, or switch. For the purpose of examination, the examiner is interpreting this as switch.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 2-21 are 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.
Regarding Claims 2-3, 6, 13, 16, & 20:
Claim limitation “secondary actuator” is described in ¶0008-¶0010, ¶0012, & ¶0015 of the Specification, but no specific device is named. MPEP §2181, IV states “Merely restating a function associated with a means-plus-function limitation is insufficient to provide the corresponding structure for definiteness. See, e.g., Noah, 675 F.3d at 1317, 102 USPQ2d at 1419; Blackboard, 574 F.3d at 1384, 91 USPQ2d at 1491; Aristocrat, 521 F.3d at 1334, 86 USPQ2d at 1239. It follows therefore that such a mere restatement of function in the specification without more description of the means that accomplish the function would also likely fail to provide adequate written description under section 112(a) or pre-AIA section 112, first paragraph.”. The specification only functionally describes the part without disclosing whether this actuator may represent items such as a motor, belt, spring, or switch. Therefore, the claim lacks written description.
Claims 3-12 are further rejected for depending upon rejected claim 2.
Claims 14-19 are further rejected for depending upon rejected claim 13.
Claim 21 is further rejected for depending upon rejected claim 20.
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 limitation “secondary actuator” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
Regarding Claims 2-3, 6, 13, 16, & 20:
Claim limitation “secondary actuator” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Though the “secondary actuator” is described in ¶0008-¶0010, ¶0012, & ¶0015 of the Specification, no specific device is named, and it is unclear what the secondary actuator is if it could represent many components such as a motor, belt, spring, or switch. For the purpose of examination, the examiner is interpreting this as switch. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Claims 2-6 are further rejected for depending upon rejected claim 1.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Allowable Subject Matter
Claims 2-21 are deemed to be allowable after the related 112(a) and 112(b) rejections have been addressed.
The following is an Examiner's statement of reasons for allowance:
None of the prior art of record (Shuman et al (US Publication No. 20180263681) and Hancock et al. (US Publication No. 20190167077) explicitly discloses or teaches all of the claim’s elements of independent Claims 2, 13, & 20, particularly as currently written. After further search and consideration, it has been determined that the prior art and possible combination of relevant references fails to arrive at the claimed invention, particularly the “rotating the secondary actuator relative to the primary actuator to cause the secondary actuator to travel independently of the primary actuator along a helical path to a second position to motivate the distal end of the secondary electrode to move independently of the primary electrode relative to the target region”. The closest prior art includes helical paths for both the primary actuator and the secondary actuator, but does not provide a helical path that is used independently for both the primary and secondary actuators, where the actuators can be slidable in concert (i.e. together) and also moved independently of each other.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN FEDORKY whose telephone number is (571)272-2117. The examiner can normally be reached M-F 9:30-4:30.
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, Jennifer McDonald can be reached on M-F 9:30-4:30. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGAN T FEDORKY/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
Prosecution Insights