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 .
Priority
The application claims benefit as a Continuation of PCT/EP2023/057809 (27 March 2023) which claims benefit to DE 102022107541.9 (30 March 2022).
Formal Matters
Claims 1-18 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/21/2024 has been considered by the examiner. A signed copy is attached.
Claim Interpretation
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.
Claim Objections
Claim 4 is objected to because of the following informalities: line 3 recites “an displacement”. The recitation should be “a displacement”. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: line 2 recites the phrase “extends over”. The word “over” appears unnecessary in the claim. The phrase “wherein the inner bore extends the entire axial length of the guide instrument” [e.g. omitting the word “over”] is sufficiently clear without including potentially confusing or awkward colloquial phrasing.
Specification - Objections
The disclosure is objected to because of the following informalities: ¶92 refers to FIG 27 and expressly states that “[t]he axially central portion 41a is covered in perspective in FIG 27.” However, FIG 27 does not show element 41a at all. Element 41a is shown in FIG 28, and is indicated in the specification as being shown in FIG 28 at ¶93. However, the specification is at odds with the Drawings insofar as element 41a is concerned in FIG 27 at ¶92.
Appropriate correction is required.
Drawings - Objections
The drawings are objected to because element 41a is missing in FIG 27, as stated expressly stated the specification at ¶92. Element 41a is shown in FIG 28, but it is not shown in FIG 27 as indicated in the specification at ¶92. 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.
Claim Rejections - 35 USC § 112(b)
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 1-18 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.
Regarding claim 1, line 2, the phrase "in particular", which is exemplary and similar to the phrase “such as” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 2, lines 2-3 recites that the curvature of the first portion of the feed tube is “user-defined or user-defined variably or manually adjustable”. The metes and bounds of the phrase “user-defined variably” is unclear and confusing. The phrase appears only once in the specification at ¶14 where it is recited as a middle position between the curvature being “user-defined” and “preferably manually adjustable”. The range of user-defined adjustment subsumes the full range of flexibility of the instrument by an undisclosed user-defined means to being manually adjustable, which is also confusing because manual adjustability also assumes or necessitates user-involvement. The specification at ¶14 also states that the curvature can have a predefined axis and/or a predefined curvature radius, but it is unclear whether this pre-defined option is encompassed in or within the “user-defined” or “manually adjustable” range of curvatures. Accordingly, the specification is of limited assistance in providing additional information as to the meets and bounds of the claimed recitation of curvature in claim 2.
Regarding claim 3, which is dependent on claim 1, recites “wherein the first portion is arranged in a distal region of the feed tube”. This recitation is unclear and confusing because the antecedent basis on which the claim depends is directed to “a first portion of the feed tube.” When the limitation recited in claim 1 that provided the antecedent basis for “the first portion” in claim 3 is read together, it reads as “the first portion [of the feed tube] is arranged in a distal region of the feed tube”. This doesn’t make sense. If the intent is to refer to the curvature of the feeding tube as “the first portion” then this should be clarified and proper antecedent basis provided. Regarding claim 5, line 2, the phrase “is assumed” is unclear and confusing. The word “assumed” has different meanings and it is unclear which meaning is intended in the claim. The specification at ¶17 states that “the feed tube can be linearly moveable by means of an actuator in order to be able to assume its assertion position and/or its feed position. It is unclear whether Applicant is trying to define an initial or starting position and if so, whether that is device-defined or user-defined.
Regarding claim 6, lines 1-2, the phrase “at least indirectly” is unclear and confusing. The phrase appears twice in the specification. The relevant disclosure for claim 6 is found at ¶18 where the phrase is recited as: “the actuator is “at least indirectly connected to the feed tube, in particularly directly and/or in a positive fit”. However, this paragraph does not otherwise define the metes and bounds of the phrase or provide a reasonable way to ascertain the metes and bounds of what is to be considered “at least indirectly”.
Claim 6, line 2 recites “a positive fit.” As mentioned above, the recitation of “a positive fit” is found in the specification at ¶18. However, it is unclear what this phrase is intended to mean, even when read in context in ¶18, as it is an alternative to “directly” connected to the feed tube. There are eight recitations of “a positive fit” in the specification, but none provide a clear definition or indication of what the phrase means in context. There also appear to be contradictory meanings, such as where, in ¶19, the paragraph reads in relevant part “is in particular connected in a positive fit, in particular screwed, to a proximal handle part.”
Claim 7, line 2 recites the phrase “without external force”. However, it is unclear what the metes and bounds of the phrase are supposed to convey. There are two recitations of “external force” in the specification. The phrase is found at ¶22 such that “[t]he guide instrument can be in the insertion position independently without any external force.” The paragraph indicates that a “resilient material” which is exemplified as a shape memory alloy and or a plastics material such as polyethylene is used. The second recitation at ¶77 is directed to the distal end region 41 of feed tube 39 in FIG 10.
Regarding claim 8, line 2, recites that the feed tube is surrounded “at least in portions” by a rigid guide tube. The recitation of “at least in portions” is unclear and confusing as there is no clear indication as to where the structure of the rigid guide tube is supposed to be surrounding the feed tube, how far or how little it extends (e.g, length) and whether or not the portions are contiguous or discrete or in multiple discrete sections (e.g. location(s)).
Regarding claim 10, line 2, the phrase “at least indirectly” is unclear and confusing. The phrase appears twice in the specification. The relevant disclosure for claim 10 is found at ¶25 where the phrase is recited as: “[t]he feed tube can be connected to the actuator at least indirectly via a pull wire”. However, this paragraph does not otherwise define the metes and bounds of the phrase or provide a reasonable way to ascertain the metes and bounds of the structure of what is to be considered “at least indirectly”. There are examples in the paragraph for a direct connection “to the proximal end of the feed tube and/or an upper side of the feed tube” or an alternatively recitation where the pull wire is connected to an abutment, but the paragraph continues without further mentioning the feed tube or explaining how the feed tube and the abutment are related such that one could reasonably ascertain the indirect interconnections between a pull wire and the feed tube.
Claim 11 is unclear and confusing. The claim recites “wherein the guide instrument is designed as a disposable instrument”. The intent of the design is noted, but in a claim drawn to a medical guide instrument the instrument either is or isn’t disposable. The phrase “is designed as as” renders the claim ambiguous, unclear, and confusing. The specification at ¶24 states that the instrument is designed, in particular to be reusable or alternatively as a disposable instrument. The specification at ¶28 recites that the “guide instrument can be designed as a disposable instrument”. It is unclear whether the intent in the design of the instrument, as recited in claim 11, impacts its ultimate use as being disposable or reusable. As written, the design of the instrument as a disposable instrument may be interpreted as “being capable of” being disposable, which creates confusion as to whether the guide instrument is actually a disposable instrument.
Claim 12 is unclear and confusing in reciting “wherein the first portion of the feed tube is arranged in an axially central portion of the feed tube”. It is unclear how the first portion can be arranged in an axially central portion of itself. The specification at ¶28 recites that the first portion of the feed tube can be arranged in an axially central portion, but the sentence appears to be referring to the guide instrument as the structure in which the first portion of the feed tube is arranged in an axial central portion.
Claims 4, 9, and 15-18 are rejected as depending from rejected claims. It is also noted that although claims 15, 17, and 18 are independent device and method claims, all three claims incorporate the dependency of the medical guide instrument of claim 1, which is rejected as being unclear and confusing.
Applicant is referred to Ex parte Miyazaki, 89 USPQ2d 1207, 1211 (2008). A five member expanded panel of the Board held that "if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 USC 112, second paragraph, as indefinite."
Applicant is also referred to Nautilus Inc., v. Biosig Instruments, Inc., 572 U.S. 898, 908-909 (2014) in which the Court held that a claim is indefinite if the specification and prosecution history fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention. The Court also held that a patent must be precise enough to afford clear notice of what is claimed thereby "appris[ing] the public of what is still open to them (citing Markman v. Westview Instruments, Inc., 517 U.S. 370, 373 (1996)), in a manner that avoids "[a] zone of uncertainty which enterprise and experimentation may enter only at the risk of infringement claims," (citing United Carbon Co., v. Binney & Smith Co., 317 U.S. 228, 236 (1942)) (Nautilus 909).
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)(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 1-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Patel et al., US 20150297246 (22 October 2015).
Regarding independent claim 1, Patel teaches a medical guide instrument (FIGs 8-18B, system 201, ¶157) for a medical electrode (¶35) for positioning the electrode (¶35) on spinal nerves in a spinal canal (FIG 11, basivertibral nerve, ¶162), in particular on spinal nerve nodes, the guide instrument (201) comprising:
a distal feed tube (curvable cannula 230, ¶160) for receiving the electrode (274/276),
wherein, when the guide instrument (201) is in an insertion position (FIGs 10C, 10D; ¶161), a first portion (FIGs 12, 14, BRI: distal end region) of the feed tube (230) has a curvature (deformable and deployed in a curved configuration, ¶164), and
wherein, when the guide instrument (201) is in a feed position (FIGs 10A, 10B; ¶161), the first portion of the feed tube (230) is substantially linear (delivered in a straight configuration, ¶164).
Regarding claim 2, Patel teaches the medical guide instrument according to claim 1, as set forth above, wherein, in the insertion position (FIGs 10C, 10D; ¶161), of the guide instrument (201), the curvature of the first portion (deformable and deployed in a curved configuration, ¶164), of the feed tube (230) is user-defined or user-defined variably or manually adjustable (pull cord 242, dial 212; ¶168).
Regarding claim 3, Patel teaches the medical guide instrument according to claim 1, as set forth above, wherein the first portion (FIGs 12, 14) is arranged in a distal region of the feed tube (230) and is designed to be flexible as a distal end region (deformable and deployed in a curved configuration, ¶164).
Regarding claim 4, Patel teaches the medical guide instrument according to claim 1, as set forth above, wherein a change between the feed position (FIGs 10A, 10B; ¶161) and the insertion position (FIGs 10C, 10D; ¶161) of the guide instrument (201) is carried out due to an [sic] displacement (FIGs 10A-E) of the feed tube (230).
Regarding claim 5, Patel teaches the medical guide instrument according to claim 1, as set forth above, wherein the guide instrument (201) has an actuator (FIG 8, dial 212, ¶168) via which the insertion position (FIGs 10C, 10D; ¶161) of the guide instrument (201) is assumed.
Regarding claim 6, Patel teaches the medical guide instrument according to claim 5, as set forth above, wherein the actuator (FIG 8, dial 212, ¶168) is at least indirectly connected (cord 242 coupled to male-threaded dial 212 to act as a pull cord to apply tension, ¶168) to the feed tube (230) or directly and in a positive fit.
Regarding claim 7, Patel teaches the medical guide instrument according to claim 1, as set forth above, wherein the guide instrument (201) is automatically in the insertion position without external force (“a tube-within-tube system comprises a deployable curved tube that deploys from a straight cannula”, ¶8; “delivered in a straight configuration through the trocar and deployed in a curved configuration outward from the radial opening at an angle with respect to the central axis” ¶164).
Regarding claim 8, Patel teaches the medical guide instrument according to claim 1, as set forth above, wherein the feed tube (230) is surrounded at least in portions by a rigid guide tube (trocar 210, ¶163).
Regarding claim 9, Patel teaches the medical guide instrument according to claim 1, as set forth above, wherein the guide instrument (201) has an inner bore (central bore and continuous channel, ¶164) for receiving the electrode (FIGs 10C, D; electrodes 274/276), and wherein the inner bore (¶164) extends over the entire axial length of the guide instrument (FIG 9, ¶164).
Regarding claim 10, Patel teaches the medical guide instrument according to claim 5, as set forth above, wherein the feed tube (230, ¶168) is connected to the actuator (dial 212, ¶168) at least indirectly via a pull wire (pull cord 242, ¶168).
Regarding claim 11, Patel the medical guide instrument according to claim 1, as set forth above, wherein the guide instrument (201) is designed as a disposable instrument (made of Nitinol, PEEK, or other thermoplastic, ¶33).
The phrase “designed as a disposable instrument” is broadly interpreted in light of the specification at ¶24. The specification states that the instrument is designed, in particular to be reusable or alternatively as a disposable instrument. The specification at ¶24 recites that if the “guide instrument is designed as a disposable instrument, the feed tube can be made of plastics material”.
The phrase “is designed as” in an apparatus claim is broadly interpreted as a “capable of” statement that is a function rather than a positive structural limitation and only requires the ability to so perform. It does not constitute a limitation in any patentable sense. See In re Hutchison, 69 USPQ 138, 33 CCPA 879 (1946). Patel teaches that the instrument may be made of thermoplastic, which meets the functional disposal “design requirements” in the specification at ¶24 of a disposable instrument being made of plastic material.
Regarding claim 12, Pellegrino the medical guide instrument according to claim 1, as set forth above, wherein the first portion (FIGs 12, 14, BRI: distal end region) of the feed tube (230) is arranged in an axially central portion (FIG 12, central bore, ¶164) of the feed tube (230).
Regarding claim 13, Patel the medical guide instrument according to claim 1, as set forth above, wherein the guide instrument (201) has a flattening on its outer surface (FIG 8, stop nut 240).
Regarding claim 14, Patel the medical guide instrument according to claim 1, as set forth above, further comprising an adapter part (FIG 11, trocar housing 202, ¶163) with an inner bore (FIG 11, trocar recess, ¶160) for receiving the electrode (274/276), wherein the inner bore (FIG 11, trocar recess, ¶160) of the adapter part (202) is radially widened towards the proximal end face and/or towards the distal end face of the adapter part (FIG 11).
Regarding independent claim 15, Patel teaches a medical instrument set comprising: the medical guide instrument (201) according to claim 1; and a medical electrode (274/276) with at least one electrically conductive contact surface and with a line (wire, ¶277) connected to the electrode (¶277).
Regarding claim 16, Patel teaches the medical instrument set according to claim 15, as set forth above, wherein the line (wire, ¶277) has at least one resilient portion (array, ¶277) and/or at least one rigid portion (terminal, ¶277). The “at least one resilient portion” is interpreted in its broadest reasonable interpretation in light of ¶80 of the specification which recites that electrode 20 is shown in a curved arrangement in FIG 13).
Regarding independent claim 17, Patel teaches a medical device comprising: a medical guide instrument according to claim 1, as set forth above; and a medical endoscope (¶268), wherein the guide instrument is adapted to be received in a working canal of the endoscope (¶268).
Regarding independent claim 18, Patel teaches a medical method (FIGs 10A-E) for arranging a medical electrode on spinal nerves via the medical guide instrument (201) according to claim 1, as set forth above, the method comprising:
providing access to the spinal nerves (FIG 10A);
inserting the medical guide instrument in the feed position for positioning the electrode on the spinal nerves (FIG 10A);
activating the insertion position of the medical guide instrument (FIG 10C, D); and
inserting the electrode through the medical guide instrument through its feed tube until the electrode is positioned on the nerves (FIG 10E).
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Pellegrino et al., US 8,361,067 (29 January 2013), teaches methods of therapeutically heating a vertebral body to treat back pain.
Pellegrino et al., US20130006232 (3 January 2013), teaches methods of therapeutically heating a vertebral body to treat back pain.
Swoyer et al., US 20070038052 (15 February 2007), also published as US 7,844,348 (30 November 2010), teaches fiber optic assisted medical lead.
Burdulis, US 20140257240 (11 September 2014) teaches articulable introducer sheath.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-F 9am-6pm (CST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHERIE M POLAND/Examiner, Art Unit 3771
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