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 07/31/2023 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.
Claims 1, 11, 13-15, and 17-20 is 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: “accessory means” in claims 1, 11, 13-15, and 17-20.
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 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 2-12 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.
Claims 2-12 excessively use the word “or” and “and/or”. This renders the claim indefinite because it is unclear what is actually intended to be included in the claim limitation. The examiner suggests cleaning up the claims to better provide the scope of the claimed invention.
Claim 2, line 3 recites the limitation "sealing material". There is insufficient antecedent basis for this limitation in the claim. The examiner suggests amending the claim to read “the sealing material”.
Claim 2, line 3 recites the limitation "sealing material". There is insufficient antecedent basis for this limitation in the claim. The examiner suggests amending the claim to read “the sealing material”.
The term "preferably" found in claims 2, 4-5 is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ74 (Bd. App. 1961); Ex parte Hall, 83 USPQ38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ481 (Bd. App. 1949). The language “preferably” is also broad language followed by narrow language.
The term "e.g." found in claims 5 and 11 is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ74 (Bd. App. 1961); Ex parte Hall, 83 USPQ38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ481 (Bd. App. 1949). The language “e.g.” is also broad language followed by narrow language.
The term “essentially” in claim 11, lines 3-4 is a relative term which renders the claim indefinite. The term “essentially not” 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. The examiners suggests removing the word “essentially”.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Landon et al (US 2022/0287836 A1).
Regarding claim 1, Landon discloses a replacement heart valve prosthesis (Figures 39A-D, paragraph 0007) comprising a sealing material (Figures 39A-d, items 1580 and 1680 “outer skirt”; paragraph 0361) wherein the sealing material contains at least one predefined passage (Figures 38A-D, items 1591 “port”) suitable for an accessory means (Figure 42, paragraphs 0379 and 0391 discloses that predefined passage taught by Landon is capable of receiving the accessory means).
Regarding claim 2, Landon discloses a replacement heart valve prosthesis wherein the replacement heart valve prosthesis (Figures 39A-D; paragraph 0342) comprises a frame (Figures 39A-d, items 1520 and 1540), a replacement heart valve (Figures 39A-D, item 1560) and sealing material (Figures 39A-D, items 1580 and 1590), preferably a single stent or an inner and an outer frame (paragraph 0342 discloses inner frame 1520 and outer frame 1540), preferably an inner and outer stent (Figure 39C depicts a stent).
Regarding claim 3, Landon discloses a replacement heart valve prosthesis wherein the sealing material comprises one or more radiopaque suture lines or/and one or more suture points or an area on or in the sealing material marked with one or more radiopaque markers (Figure 40B, depicts a radiopaque marker 2400 in the sealing material 1680; paragraph 0388).
Regarding claim 4, Landon discloses a replacement heart valve prosthesis wherein the predefined passage (Figures 39A-D, item 1591) contains a hemostatic valve (Figure 39G, item 2310 “valve”; paragraph 0385), preferably wherein the hemostatic valve is positioned between or within one or more radiopaque suture lines or points or areas or radiopaque markers (Figure 39G, item 2312 “radiopaque marker”, paragraphs 0386 and 0388).
Regarding claim 5, Landon discloses a replacement heart valve prosthesis wherein the hemostatic valve comprises or is composed of natural or synthetic material (paragraph 0383, the body 2206 of the port 2200 that forms a seal against the accessory may be formed from an elastomeric material, such as fluoroelastomer or silicone, which is a synthetic material), preferably any biocompatible material (fluoroelastomer and silicone and biocompatible materials), e.g. pericard or/and one or more polymers (fluoroelastomer and silicone are polymers).
Regarding claim 6, Landon discloses a replacement heart valve prosthesis wherein the hemostatic valve comprises 2, 3 or 4 leaflets or lips or tissue layers (Figure 39G, item 2310, paragraph 0385 discloses a duckbill valve, and Figure 39G depicts 2 lips).
Regarding claim 7, Landon discloses wherein the predefined passage (Figures 39A-D, item 1591) or/and one or more radiopaque suture lines or/and one or more suture points or an area on or in the sealing material marked with one or more radiopaque markers is positioned on or in the sealing material outside the single stent, or between the inner and outer frame or stent, or/and essentially outside of the replacement heart valve(Figure 40B, depicts a radiopaque marker 2400 in the sealing material 1680 between the inner frame 1620 and outer frame 1640; paragraphs 0358 and 0388).
Regarding claim 8, Landon discloses wherein the predefined passage (Figures 39A-D, item 1591) is aligned with the inside or outside of the single stent, or inside or outside of the inner frame or stent (Figures 39A-D depicts the predefined passage 1591 outside of inner frame 1520, paragraph 0342) or it forms an integral part of the single stent or of the inner frame or stent.
Regarding claim 9, Landon discloses wherein the predefined passage is attached inside or outside of the single stent or inner frame or stent (Figures 39A-D depicts the predefined passage 1591 outside of inner frame 1520, paragraph 0342), or the predefined passage is positioned with a distance from the inner frame or stent of 1 to 5 mm or/and with a distance from the outer frame or stent of 5 to 20 mm.
Regarding claim 10, Landon discloses wherein the inner frame or stent or/and the predefined passage is mechanically isolated from the outer frame or stent, or wherein the predefined passage is mechanically isolated from the single, the inner frame or stent or/and the outer frame or stent stent (Figures 39A-B depicts wherein the inner frame 1520, predefined passage 1591, outer frame 1540 are mechanically isolated from each other such that it does not interfere with the heart beat).
Regarding claim 11, Landon discloses wherein the accessory means, e.g. a catheter, a probe or an electrode (Figure 42, item 2600; paragraph 0398), positioned within the predefined passage does essentially not effect a horizontal or vertical movement during heart beating or/and is essentially protected or/and is essentially isolated from a horizontal or vertical movement (the position of the predefined passage 1591 does not affect horizontal or vertical movement during heat beating); paragraph 0357; the “accessory means” is recited in claim 1 as the intended use of the predefined passage, and is not positively recited as part of the claimed invention. Therefore, the prior art is not required to disclose the accessory means positioned in the passage or any the functions, and the capability meets the functional requirements).
Regarding claim 12, Landon discloses wherein the hemostatic valve (Figure 39G, item 2310 “valve”; paragraph 0385) is foldable or/and has a low profile (hemostatic valve 2310 is low profile in the same manner as the claimed valve depicted in Figure 4 of the applicant’s drawings).
Regarding claim 13, Landon discloses wherein the replacement heart valve prosthesis comprises one or more guidance means for the accessory means (paragraph 0356 “The port 1591 as shown in FIG. 39A may include a tube that extends along the height of the implant 1500 to guide the pacemaker lead through the implant 1500”; the “accessory means” is recited in claim 1 as the intended use of the predefined passage, and is not positively recited as part of the claimed invention. Therefore, the prior art is not required to disclose the accessory means positioned in the passage or any the functions, and the capability meets the functional requirements).
Regarding claim 14, Landon discloses a system comprising a replacement heart valve prosthesis (Figures 39A-D) and the accessory means (Figures 39A-D, item 1591 “port”; Figure 42, item 2600 “pacemaker pacing lead”; the “accessory means” is recited in claim 1 as the intended use of the predefined passage, and is not positively recited as part of the claimed invention. Therefore, the prior art is not required to disclose the accessory means positioned in the passage or any the functions, and the capability meets the functional requirements) comprises one or more fixing means (paragraphs 0383 and 0385 discloses that a seal is formed around the diagnostic or therapeutic device which would serve as a fixing means).
Regarding claim 15, Landon discloses a method for introducing an accessory means, in a patient carrying a replacement heart valve prosthesis wherein the predefined passage (Figures 39A-D, item 1591 “port”; paragraph 0356) is visualized (Figures 39E-G, item 1597; paragraph 0382) and the accessory means (Figure 42, item 2600) is introduced into and pushed through the predefined passage and positioned in its final target position (Figure 42, paragraph 0391).
Regarding claim 16, Landon discloses wherein the at least one predefined passage is suitable for a catheter, a probe or an electrode (paragraph 0398).
Regarding claim 17, Landon discloses wherein the accessory means is a catheter, a probe or an electrode (paragraph 0398).
Regarding claim 18, Landon discloses wherein the accessory means is a catheter, a probe or an electrode (paragraph 0398).
Regarding claim 19, Landon discloses wherein the accessory means includes a pacemaker or defibrillator lead (paragraph 0356).
Regarding claim 20, Landon discloses wherein the accessory means is a lead or an electrode (paragraph 0356).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA LYNEE ZIMMERMAN whose telephone number is (313)446-4864. The examiner can normally be reached Mon. 8:30 AM-6:30 PM, Tues. - Fri. 8:30-4:00 PM.
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, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA LYNEE ZIMMERMAN/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774