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 4/2/25 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 use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “penetration means” in claim 1.
Because this claim limitation(s) is not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation does not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Objections
Claim 2 objected to because of the following informalities: claim 2 is written in multiple dependent form: “A biomedical device according to any of the previous claims…” There is only a single previous claim (claim 1). Claim 1 should read: --A biomedical device according to claim 1--. Appropriate correction is required.
Claim 4 objected to because of the following informalities: in line 3, the term “them” is used. The Examiner suggests amending the claim to avoid use of this terminology. Appropriate correction is required.
Claims 5-15 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, claims 5-15 have not been further treated on the merits.
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 4 is 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.
Claim 4 is written in multiple dependent form. When dependent on claim 2, claim 4 is not clear. The Applicant discloses that the arms may be connected directly to the central component (e.g., by means of clamping elements) or indirectly (e.g., by means of guiding elements), but not both together. It appears that claim 4 should only be dependent on claim 1 instead of in multiple dependent form. Appropriate correction is required.
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)(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 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Feuer et al. (US 2018/0014822 A1) (“Feuer”).
Regarding claim 1, Feuer discloses (Figures 1-15B) a biomedical device for closing an opening of a human or animal body wall (Figures 2-6), the device comprising:
- a central component (150) having a central axis, and
- a plurality of arms (see Figure 14A annotated below) movably connected to the central component so as to transform the device between different configurations, said configurations comprising a delivery configuration (Figures 2, 12, 13A), a deployed configuration (Figures 4, 13B, 14A) and a retracted configuration (Figures 6-9, 11, 13C, 14B); wherein:
- said arms comprise an elongated arm portion (see Figure 14A annotated below), and penetration means (115) for penetrating said body wall (paragraph 0051);
- the elongated arm portions form an angle smaller than 20 degrees relative to the central axis when the device is in said delivery configuration (Figure 2, 12, 13A);
- the elongated arm portions are oriented substantially perpendicular to the central axis, and a tip of the penetration means (115) is located at a first distance from the central axis (A), when the device is in said deployed configuration (Figures 4, 13B, 14A);
- the elongated arm portions are oriented substantially perpendicular to the central axis, and the tip of the penetration means (115) is located at a second distance from the central axis, smaller than the first distance, when the device is in said retracted configuration (Figures 6-9, 11, 13C, 14B; paragraph 0065), and wherein the penetration means (115) comprises a barb (hook) for anchoring the penetration means in said body wall (paragraph 0065).
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Regarding claim 2, Feuer discloses (Figures 1-15) that the biomedical device further comprises a plurality of guiding elements (130) hingedly connected to the central component (paragraph 0061), configured for receiving respective elongated arm portions; and wherein each arm is slidingly connected to a respective guiding element (paragraph 0081; Figures 5-6, 10A-10B, 13B-13C, 14A-14B, 15A-15B).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Feuer et al. (US 2018/0014822 A1) (“Feuer”) in view of Joyeux et al. (US 2017/0340315 A1) (“Joyeux”).
Regarding claim 3, Feuer discloses the invention substantially as claimed. However, Feuer fails to disclose that the guiding elements have a shape configured to contact each other in an edge-to-edge manner to form a smooth surface, when the device is in the deployed or retracted configuration.
In the same field of endeavor, Joyeux teaches (Figure 7) a biomedical device for closing an opening of a human or animal body wall comprising guiding elements (1) that have a shape configured to contact each other in an edge-to-edge manner (paragraphs 0077-0078) to form a smooth surface, when the device is in a deployed configuration.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the guiding elements disclosed by Feuer to have a shape configured to contact each other in an edge-to-edge manner to form a smooth surface when the device is in the deployed configuration, as taught by Feuer. This modification would form a watertight sealed structure (Joyeux, paragraph 0174).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Feuer et al. (US 2018/0014822 A1) (“Feuer”) in view of Prior et al. (US 2015/0038991 A1) (“Prior”).
Regarding claim 4, Feuer discloses (Figures 1-15B) a biomedical device for closing an opening of a human or animal body wall (Figures 2-6), the device comprising:
- a central component (150) having a central axis, and
- a plurality of arms (115, 130) movably connected to the central component so as to transform the device between different configurations, said configurations comprising a delivery configuration (Figures 2, 12, 13A), a deployed configuration (Figures 4, 13B, 14A) and a retracted configuration (Figures 6-9, 11, 13C, 14B); wherein:
- said arms comprise an elongated arm portion (130), and penetration means (115) for penetrating said body wall (paragraph 0051);
- the elongated arm portions form an angle smaller than 20 degrees relative to the central axis when the device is in said delivery configuration (Figure 2, 12, 13A);
- the elongated arm portions (130) are oriented substantially perpendicular to the central axis, and a tip of the penetration means (115) is located at a first distance from the central axis (A), when the device is in said deployed configuration (Figures 4, 13B, 14A);
- the elongated arm portions (130) are oriented substantially perpendicular to the central axis, and the tip of the penetration means (115) is located at a second distance from the central axis, smaller than the first distance, when the device is in said retracted configuration (Figures 6-9, 11, 13C, 14B; paragraph 0065), and wherein the penetration means (115) comprises a barb (hook) for anchoring the penetration means in said body wall (paragraph 0065).
Feuer discloses that a spring hinge can couple the arms to the central component. In other embodiments, a strip of elastically deformable material can be implemented to connect the arms to the central component. Feuer discloses the wound closure device may include any type of coupling between the arms and the central component that allows the arms to rotate about the central component and at least partially extend from the central component (paragraph 0061). However, Feuer fails to explicitly disclose the central component further comprises a plurality of clamping means, configured for receiving a respective arm between them; and wherein the arms further comprise an elongated slot or a trench or a groove for engaging with the clamping means.
The limitation “clamping means” is being interpreted under being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Because this 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 only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof. The Applicant discloses that the “clamping means” comprise pairs of pillars extending from the base, and a protruding (e.g. cylindrical) element extending from each pillar for engaging or clamping the arms between them (Page 5, lines 4-6). The Applicant discloses that “the clamping means” can comprise pairs of pillars extending from the base, and an element, e.g. a cylindrical element, interconnecting these pillars (Page 5, lines 7-8).
Prior teaches (Figures 1-2B, 11A-12) a pivotal coupling between arms (542) and a central component (540) that allows the arms to rotate about the central component and at least partially extend from the central component. Prior teaches that the central component (540) comprises pillars and each arm is positioned between two pillars (Figure 12). Prior teaches that each arm has a slot to engage with a pivot pin to provide a pivotal connection between each arm and the central component (paragraph 0091).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the clamping means and elongated slot coupling taught by Prior for the coupling disclosed by Feuer. Feuer discloses the wound closure device may include any type of coupling between the arms and the central component that allows the arms to rotate about the central component and at least partially extend from the central component (paragraph 0061). Substitution of one known element (the clamping means and slot coupling taught by Prior) for another element (the coupling disclosed by Feuer) providing the same function to yield predictable results (a pivotal connection between the arms and the central component) would have been obvious to one of ordinary skill in the art at the time of the invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN D KNAUSS whose telephone number is (571)272-8641. The examiner can normally be reached M-F 12:30-8:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771
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