DETAILED ACTION
The following Office Action is in response to the Non-Provisional Patent Application filed on May 30, 2024. Claims 1-18 are currently pending.
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 .
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.
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 15 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. Line 3 of the claim recites the limitation of “the tissue depressor form”. There is a lack of antecedent basis for this limitation in the claim. For the purposes of compact prosecution, the limitation will be interpreted as “the tissue depressor means”.
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.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wilson et al. (US 2018/021469).
Concerning claim 1, the Wilson et al. prior art reference teaches a puncture locator device (Figure 6; 230) comprising: a handle (Figure 6; 235); a tissue depressor form (Figure 6; 233); and a needle channel that passes through at least a portion of the tissue depressor form (Figure 6; lumen of 231).
Concerning claim 2, the Wilson reference teaches the device of claim 1, wherein the tissue depressor form defines an axis, and the needle channel is angled with respect to the axis (defines a 90° angle).
Concerning claim 3, the Wilson reference teaches the device of claim 1, wherein an axis of the handle is parallel with an axis of the tissue depressor form (Figure 6; 235, 233).
Concerning claim 4, the Wilson reference teaches the device of claim 1, wherein the handle is coaxial with the tissue depressor form (Figure 6; 235, 233).
Concerning claim 5, the Wilson reference teaches the device of claim 1, wherein the needle channel passes through at least a portion of the handle (Figure 6; lumen of 231 passes through a distal portion of handle 235).
Concerning claim 6, the Wilson reference teaches the device of claim 6, further comprising a stabilizer structure disposed proximal to the tissue depressor form (Figure 6; outer tube 231 may be defined as stabilizer).
Claim(s) 1, 6-8, 12-13, and 15-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wilson et al. (US 2018/021469).
Concerning claims 1 and 6-8, the Lukoschek et al. prior art reference teaches a puncture locator device (Figure 2; 1) comprising: a handle (Figure 1; 2); a tissue depressor form (Figure 1; cone 6 may depress tissue); and a needle channel that passes through at least a portion of the tissue depressor form (Figure 1; 4), further comprising a stabilizer structure disposed proximal to the tissue depressor form (Figure 1; cylindrical structure of 3 attached to cone 6), wherein: the handle projects proximally from the stabilizer structure, and the tissue depressor form projects distally from a tissue contact surface of the stabilizer structure (distal end of cylindrical structure of 3), wherein the tissue contact surface has a diameter that is greater than a diameter of the tissue depressor form.
Concerning claim 12, the Lukoschek et al. prior art reference teaches a puncture locator device (Figure 2; 1) comprising: a tissue contacting structure (Figure 1; seat 3 may contact tissue) including: a stabilizer means (Figure 1; outer diameter portion of 3); and a tissue depressor means (Figure 1; cone 6 may depress tissue), and a needle channel formed in the tissue-contact structure (Figure 1; 4).
Concerning claim 13, the Lukoschek reference teaches the puncture locator device of claim 12, wherein the needle channel has a distal opening on a front surface of the tissue depressor means (Figure 1; 5).
Concerning claim 15, the Lukoschek reference teaches the puncture locator device of claim 12, wherein: the stabilizer means comprises a distal tissue-contact surface (Figure 1; distal end of 3 attached to cone 6); and the tissue depressor means emanates from the tissue-contact surface of the stabilizer means (Figure 1; 6).
Concerning claim 16, the Lukoschek reference teaches the puncture locator device of claim 12, wherein the tissue depressor means may comprise a bulbous dome that projects from the stabilizer (Figure 4; 3).
Concerning claim 17, the Lukoschek reference teaches the puncture locator device of claim 16, wherein a diameter of the tissue depressor means expands gradually from an apex of the tissue depressor means to the stabilizer means (Figure 4; 3).
Claim(s) 1, 9-12, 14, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McGhie (US 2012/0265098).
Concerning claim 1, the McGhie reference teaches a puncture locator device (Figure 1; 10) comprising: a handle (Figure 1; 16); a tissue depressor form (Figure 1; frame 12 may depress tissue, therein being a tissue depressor form); and a needle channel that passes through at least a portion of the tissue depressor form (Figure 1; 36).
Concerning claim 9, the McGhie reference teaches the puncture locator device of claim 1, further comprising an orientation indicator indicating an orientation of the needle channel (Figure 1; apex defined by arms 24, 26 capable of being used as an orientation indicator to indicate orientation), wherein the orientation indicator is associated with a stabilizer structure of the puncture locator device (Figure 1; arms 24, 26 may be interpreted as a stabilizer structure).
Concerning claim 10, the McGhie reference teaches the puncture locator device of claim 9, wherein the orientation indicator comprises a point that is aligned with a plane of the needle channel (Figure 1; plane vertically bisecting needle channel 36 is aligned with corner of frame).
Concerning claim 11, the McGhie reference teaches the puncture locator device of claim 10, wherein: the orientation indicator has a heart shaped form (Figure 1; arms 24, 26 together form a heart shaped structure); and the point is formed by an apex of the heart-shaped form.
Concerning claim 12, the McGhie reference teaches a puncture locator device (Figure 1; 10) comprising: a tissue contacting structure (Figure 1; 12) including: a stabilizer means (Figure 1; 24, 26); and a tissue depressor means (Figure 1; bottom surface of arms 24, 26), and a needle channel formed in the tissue-contact structure (Figure 1; 36).
Concerning claim 14, the McGhie reference teaches the puncture locator device of claim 12, wherein the stabilizer may be interpreted as being a heart-shaped form (Figure 1; arms 24, 26 together form a heart shaped structure) including a point feature (Figure 1; corner of frame) that is aligned with a plane of the needle channel (Figure 1; plane vertically bisecting needle channel 36 is aligned with corner of frame).
Concerning claim 18, the McGhie reference teaches a puncture locator device of claim 12, further comprising a manual manipulation means coupled to the stabilizer means (Figure 1; boom 22 may be interpreted as a manual manipulation means given it is a handle).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Sarvazyan et al. reference (US 2004/02674121), the Kisen et al. reference (US 2005/0090741), the Crocker et al. reference (US 2009/0030338), and the Kato et al. reference (US 2018/0228568) all teach puncture locator devices of varying structures.
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/MARTIN T TON/Examiner, Art Unit 3771 8/18/2026
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