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 .
Note: all citations with respect to the specification of present application are citing the paragraph numbers in the Pre-Grant Publication US 2024/0407855 A1.
Claim Objections
Claim 1 and 10 – 20 are objected to because of the following informalities:
Claim 1 line 9, limitation “using the delivery sheath or inflation of the one or more balloons” should read “using the delivery sheath or inflating of the one or more balloons”.
Claim 10 line 2, limitation “the human” should read “the human body”.
Claim 11 line 13, limitation “the balloon” should read “the inflatable balloon”.
Claim 12 – 20, the preamble of each claim recites “The method of claim”. However, claim 12 – 20 are directly or indirectly dependent on apparatus independent claim 11. The corresponding preamble should read “the delivery system of claim”.
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.
Claim 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.
Regarding limitation “a human” in claim 1 line 8, it is unclear the above human is a newly introduced different human or the same human as recited in limitation “a human body” in claim 1 line 1.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above “human” in line 8 is interpreted as the same “human body” as introduced in line 1.
Regarding limitation “a medical device” in claim 1 line 14, it is unclear the above medical device is a newly introduced different device or the same medical device as introduced in claim 1 line 2.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above medical device in line 14 is interpreted as the same medical device as introduced in line 2.
The term “about 65-90% in volume” and “about 10-35% in volume” in claim 6 and claim 16 are relative terms which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. See MPEP 2173.05(b).
The corresponding disclosure in the specification of present application is recited as: “such that the outer portion 505 a of the balloon 505 is between about 65-90% in volume and the inner portion 505 b of the balloon 505 is between about 10-35% in volume for a total volume of 100% when fully inflated” in [0032]. The specification does not provide a range to define the term “about”. It is unclear within which range can the volume be considered as “about” the claimed percentage range.
Thus, the above limitations render claim indefinite. For the purpose of examination, the above limitations are interpreted as any reasonable range.
Regarding limitation “a lumen of the delivery sheath” in claim 9 line 2, it is unclear the above lumen is a newly introduced different lumen or the same lumen of delivery sheath as introduced in claim 1 line 14.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above lumen in claim 9 is interpreted as the same lumen as introduced in claim 1.
Regarding limitation “a human” in claim 11 line 8 – 9, it is unclear the above human is a newly introduced different human or the same human as recited in limitation “a human body” in claim 11 line 1.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above “human” in line 8 – 9 is interpreted as the same “human body” as introduced in line 1.
Claim 11, 14, 15, and 18 – 20 recite method steps in apparatus claim(s). The limitations regarding the method steps of using the claimed apparatus are as following:
Limitations “and self-expands after the sponge is deployed and reaches a right ventricle of a human or contacts bodily fluid of the human”; “wherein the delivery sheath is advanced across a tricuspid valve to the right ventricle, wherein the delivery sheath is moved or the balloon is inflated to be adjacent to a smooth inlet septum, and wherein a lead of a medical device is inserted into the smooth inlet septum” in claim 11.
Limitation “wherein the one or more balloons is either partially or fully inflated” in claim 14.
Limitation “further comprising inserting, using a syringe, a contrast dye fluid into the one or more balloons to allow for precise and accurate identification of the anatomical landmark inside the human body” in claim 15.
Limitation “wherein the outer portion of the one or more balloons abuts, rests on or pushes against the moderator band, providing mechanical support for lead advancement” in claim 18.
Limitation “wherein the one or more balloons when fully inflated do not cover or encroach on a lumen of the delivery sheath” in claim 19.
Limitation “further comprising identifying, using the X-ray or the fluoroscopy, a trabeculum septomarginalis of the human, to make advancing the lead even more precise” in claim 20.
A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011). See MPEP 2173.05(p). It is unclear whether infringement occurs when one creates a system that allows user to perform the function, or whether infringement occurs when the user actually uses the system.
Thus, the above limitations render claims indefinite. For the purposed of examination, the above limitations are interpreted as the system is specifically designed with the claimed function.
Claim 12 – 16, 18 and 20 recite the limitation "the one or more balloons" respectively. There is insufficient antecedent basis for this limitation in the claim. Limitation “an inflatable balloon” is introduced in parent claim 11, and there is no introduction of “one or more balloons”.
Claim 16 recites “an outer portion of the one or more balloons” in line 2 and “an inner portion of the one or more balloons” in line 3. It is unclear the above “outer portion” and “inner portion” are different parts or same “outer portion” and “inner portion” as introduced in claim 11 line 4.
Thus, the above limitations render claim indefinite. For the purpose of examination, the above limitations are interpreted as “outer portion” and “inner portion” of any reasonable balloon.
Claim 20 recite the limitation "using the X-ray or the fluoroscopy" in line 1. There is insufficient antecedent basis for this limitation in the claim. Parent claim 11 recites “an X-ray or a fluoroscopy display” in line 10. Only a display is introduced earlier in claim.
Claim 20 recite the limitation "advancing the lead" in line 2. There is insufficient antecedent basis for this limitation in the claim. Parent claim 11 recites “wherein a lead of a medical device is inserted into the smooth inlet septum”, there is no introducing of “advancing the lead”.
Therefore, claim 1, 6, 11 – 16, 18 – 20 and all corresponding dependent claim 2 – 5, 7 – 10 and 17 are rejected under 35 U.S.C. 112(b) second paragraph, as being indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 17 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 17 recites limitation “wherein the outer portion is larger in size and volume than the inner portion”, however parent claim 11 also recites “such that the outer portion has a greater volume than the inner portion”. The term “size” has equivalent meaning to “volume”. There is no other limitation recited in claim 17.
Thus, claim 17 fails to further limit the subject matter as recited in parent claim 11.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claim 1 – 16 and 18 – 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.
The following is a statement of reasons for the indication of allowable subject matter:
Walsh et al. (US 2020/0179050 A1; published on 06/11/2020) (hereinafter “Walsh”) and Verard et al. (US 2010/0210938 A1; published on 08/19/2010) (hereinafter “Verard”) are cited as most relevant prior arts to the claimed invention.
The claimed invention requires a specific delivery device and specific process steps to operate the delivery device. The delivery device must be operated through specific path to an inlet septum target. In addition, the ballon is manipulated to achieve the target position. Walsh teaches a catheter device with expandable balloon under the guidance of x-ray/fluoroscopy, the device is advanced to the heart to patch the septum. However, the device is not manipulated through the specific path as claimed. The delivered patch is not the lead of medical device as claimed either. Verard teaches a catheter with image (x-ray/fluoroscopy) guided navigation system, and the catheter is advanced into heart. However, the catheter path is different from the specific path as claimed, and the target is not septum either. Thus, cited prior arts in combination fails to teach all claimed features.
Regarding independent claim 1, Walsh, Verard and other search results collectively neither teach nor fairly well suggest a method for identifying an anatomical landmark inside a human body for lead fixation of a medical device, the method comprising: “advancing the delivery sheath and the one or more balloons across a tricuspid valve to a right ventricle; identifying, using X-ray or fluoroscopy, a moderator band or an anterior papillary muscle of a human; moving, using the delivery sheath or inflation of the one or more balloons, the one or more balloons to be adjacent to a smooth inlet septum; observing, using X-ray or fluoroscopy, compression or deformation of the one or more balloons when an outer curvature or a distal pole of the one or more balloons contacts the smooth inlet septum”, in combination with other limitations as recited in claim 1.
Regarding independent claim 11, Walsh, Verard and other search results collectively neither teach nor fairly well suggest a delivery system for identifying an anatomical landmark inside a human body for lead fixation of a medical device, comprising “a self-expanding sponge attached in a compressed state to the delivery sheath or the inflatable balloon and self-expands after the sponge is deployed and reaches a right ventricle of a human or contacts bodily fluid of the human;” “wherein the delivery sheath is advanced across a tricuspid valve to the right ventricle, wherein the delivery sheath is moved or the balloon is inflated to be adjacent to a smooth inlet septum”, in combination with other limitations as recited in claim 11.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHAO SHENG whose telephone number is (571)272-8059. The examiner can normally be reached Monday to Friday, 8:30 am to 5:00 pm.
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/CHAO SHENG/ Primary Examiner, Art Unit 3797