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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/14/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 is: “fixes positions” in claim 7.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification discloses in paragraphs [0055] “the body part 300 fixes the relative positions of the electrode part 100 and the guide part 200” which does not specify how the body part “fixes” the electrode part 100 and the guide part 200. For the purpose of examination, the examiner is interpreting “fixes positions” to mean the body part “encompasses” or any other equivalent.
If applicant does not intend to have this limitation 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 recites 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 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 and 7 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 the term “fine hole” is a relative term which renders the claim indefinite. The term “fine” requires subjective judgement as a range or standard for determining what “fine” is, is not disclosed. The specification does not define, or otherwise provide sufficient guidance for determining the scope of the term used in the claim. The specification does not provide a numerical tolerance, range or other standard for determining what is considered to be “fine.”
Claim limitation “fixes positions” in claim 7 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. The applicant specification states that “the body part 300 fixes the relative positions of the electrode part 100 and the guide part 200” however there is no clear link between this structure and how this function of “fixes positions” is performed. 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.
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.
Regarding claims 2, 3, 4, 5, 6, and 8, the claims are also seen as indefinite as they inherit the deficiencies of the independent claim 1.
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 1-2 and 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Schaeffer et al (US8007490B2) herein referred to as “Schaeffer” in view of Phan et al (US20050059962A1) herein referred to as “Phan.”
Regarding claim 1, Schaeffer discloses: A nasal cavity insertion-type electrode device ([col 2: line 41] the cauterization assembly, 30, is seen as the nasal cavity insertion-type electrode) comprising: an electrode part which comprises a first end having a hole formed therethrough ([col 2: lines 66-67] the second lumen, 23, is seen as the electrode part since an electrode can be placed through this lumen [col 4: lines 11-13]; the distal end 16, of this lumen is seen as the first end) and a second end having an open part formed therethrough ([col 4: lines 16-20] the proximal end is seen as the second end having an open part, lumen, formed therethrough) and has an electrode disposed therein; ([col 1: lines 24-25] an electrode may be placed in the second lumen 23 since it is capable of lesion treatment) and a guide part comprising a third end formed to be expandable ([col 2: lines 64-66] the first lumen 22 is seen as the guide part where the balloon at the end is seen as the expandable member forming the third end) and a fourth end having an open part formed therethrough to allow a fluid to enter or exit, ([col 4: lines 17-18] the proximal end where fluid is received for inflation of the balloon is seen as the fourth end) wherein the first end and the third end are arranged adjacent to each other (See FIG 4 where the distal end of 23, which is seen as the first end, and the distal end of 22, which is seen as the third end are adjacent to each other), however, Schaeffer does not explicitly disclose: an electrode part having a fine hole formed therethrough and the second end to allow a fluid to enter or exit.
Phan discloses: an electrode part having a fine hole formed therethrough (See FIG 4 where the electrode body 330 contains pores 370, which is seen as fine holes) and the second end to allow a fluid to enter or exit (See FIG 6 and [0070] where fluid 338 enters from the distal end which is seen as the second end).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode part as disclosed in Schaeffer to include a fine hole and have an electrode disposed therein as disclosed in Phan. The motivation being that using pores and having the fluid flow through the electrode part prevents overload of the fluid into the treatment area. (Phan [0072]).
Regarding claim 2, Schaeffer discloses: The nasal cavity insertion-type electrode device according to claim 1, and the electrode is inserted through the second end ([col 1: lines 24-25] an electrode may be placed in the second lumen 23 since it is capable of lesion treatment), however, Schaeffer does not explicitly disclose: wherein the electrode part is formed as a tube bent so that the first end has a U shape, and the electrode is disposed adjacent to the fine hole.
Phan discloses: wherein the electrode part is formed as a tube bent so that the first end has a U shape, (See FIG 5 where the entire electrode structure 310, which is seen as the tube, which encompasses the electrode body 330, is U shaped) and the electrode is disposed adjacent to the fine hole (See FIG 5 where the electrode body 330 is adjacent to the pores 370, which are seen as the fine holes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode part as disclosed in Schaeffer to include the first end of the electrode part having a U shaped and the electrode being disposed adjacent to the fine hole as disclosed in Phan. The motivation being that having a U-shaped structure allows the body to collapse into a lower profile. (Phan [0069]).
Regarding claim 5, Schaeffer in view of Phan discloses: The nasal cavity insertion-type electrode device according to claim 1, wherein the guide part is formed as a tube bent so that the third end has a U shape, and the third end is formed as an expandable member (Schaeffer [See FIG 4] where the third end, which is seen as 22 is U-shaped; [col 2: line 65] the third end, which is seen as 22, is in communication with the balloon and is seen as forming an expandable member).
Regarding claim 6, Schaeffer discloses: The nasal cavity insertion-type electrode device according to claim 5, however, Schaeffer does not explicitly disclose: wherein the fourth end comprises a third open part and a fourth open part which are both open parts of the tube, the third open part is sealed with a sealing member, and the fluid flows in from the fourth open part to expand the expandable member.
Phan discloses: wherein the fourth end comprises a third open part and a fourth open part which are both open parts of the tube, (See annotated FIG 6 where delivery tube 339 is seen as having a third open part and a fourth open part) the third open part is sealed with a sealing member, ([0076] the third open part includes a sealer 341) and the fluid flows in from the fourth open part to expand the expandable member (See annotated FIG 6 below where fluid flows from the fourth open part to the third open part).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ends as disclosed in Schaeffer to include the sealing member and the separate delivery tube as disclosed in Phan. The motivation being that the sealer prevents the fluid from escaping into the interior of the body (Phan [0076]) and the separate delivery tube allows the delivery tube to be removed so that the body can collapse into a lower profile. (Phan [0077]).
Regarding claim 7, Schaeffer in view of Phan discloses: The nasal cavity insertion-type electrode device according to claim 1, further comprising: a body part that fixes positions of the electrode part and the guide part (Schaeffer [See FIG 3] piece 10 is seen as the body part as it holds the electrode body part, seen as 23, and the guide part which is seen as 22 together).
Regarding claim 8, Schaeffer in view of Phan discloses: The nasal cavity insertion-type electrode device according to claim 1, wherein the electrode part and the guide part are disposed so that the third end surrounds the first end when the third end is expanded (Schaeffer [See FIG 2, middle figure, where the third end which contains the balloon, 20, surrounds the first end when expanded]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Schaeffer in view of Phan in further view of Carpentier et al (US8862244B2) herein referred to as “Carpentier”.
Regarding claim 3, Schaeffer in view of Phan discloses: The nasal cavity insertion-type electrode device according to claim 2, and portion of the fluid is discharged through the fine hole by a pressure difference (Phan [0074] fluid can be discharged through the pores based on pressure difference), however, Schaeffer in view of Phan does not explicitly disclose: wherein the second end comprises a first open part and a second open part, which are both open parts of the tube, and the fluid flows in from the first open part and flows out from the second open part.
Carpentier discloses: wherein the second end comprises a first open part and a second open part, which are both open parts of the tube, (See FIG 3A showing the proximal outlet opening which is seen as the second end; [col 3: lines 60-65] this proximal opening consists of opening 22 which is seen as the first open part and 28 which is seen as the second open part) and the fluid flows in from the first open part and flows out from the second open part (See FIG 3A where the fluid flow which is represented by the arrows shows fluid flowing in from 22 which is seen as the first open part and out of 28 which is seen as the second open part).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode device as disclosed in Schaeffer in view of Phan to include a fluid return path as disclosed in Carpentier. The motivation being this will help control and master the dissipation of heat or cold by the electrode. (Carpentier [col 2: lines 16-18]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Schaeffer in view of Phan in further view of Grunwald et al (US20090177090A1) herein referred to as “Grunwald”.
Regarding claim 4, Schaeffer in view of Phan discloses: The nasal cavity insertion-type electrode device according to claim 3, however, Schaeffer in view of Phan does not explicitly disclose: wherein the electrode part comprises at least one electrode, and the electrode is inserted from a first electrode entry/exit part branched from the first open part or a second electrode entry/exit part branched from the second open part.
Grunwald discloses: wherein the electrode part comprises at least one electrode, and the electrode is inserted from a first electrode entry/exit part branched from the first open part or a second electrode entry/exit part branched from the second open part (See FIG 2 where an electrode can be inserted through branched sections 182 or 183 [0080] and [0086]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode device as disclosed in Schaeffer in view of Phan to include a branched structure for the electrode entry/exist as disclosed in Grunwald. The motivation being that this allows for access to other devices. (Grunwald [0080]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M GANAN-SINGH whose telephone number is (571)272-3194. The examiner can normally be reached Monday to Friday 7:30am to 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne M Rodden can be reached at 3032974276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.G.S/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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