Detailed Action1
Election/Restriction
Applicant's election without traverse of Group II, claims 29-35, in the reply filed on July 16, 2026 is acknowledged.
Priority
Since the provisional application filed on August 3, 2023 does not support the claims, this application is given a priority date of March 28, 2024.
America Invents Act Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 USC 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 limitations are: crimping assembly in claim 29 and support assembly in claims 32 and 39.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Crimping assembly (that is configured to reduce in diameter or cross-sectional area at a different rate as compared to a second portion of said device opening during said operation of said crimping device, and/or b) begin reducing in diameter or cross-sectional area at a different time as compared to a second portion of said device opening during said operation of said crimping device) is interpreted as a plurality of first jaws and a plurality of second jaws, wherein jaws of the plurality of first jaws are connected to and independently movable with respective ones of the plurality of second jaws.
Support assembly is interpreted as a base and two supports extending upward from the base, the two supports having coaxially aligned openings.
If applicant does not intend to have these limitations 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.
Drawings
The drawings are objected to because figures 1-3, 10, 13-14, 21 and 24-27 have grey/black shading that reduces legibility. Solid shading is not permitted—spaced lines for shading is preferred (37 C.F.R. 1.84(m)). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 35, 42, and 43 are objected to because of an informality: “at portion” should be changed to “a portion” in line 2. Appropriate correction is required.
Rejections under 35 USC 112
The following is a quotation of 35 U.S.C. 112:
(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 29-43 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 applicant regards as the invention.
Claims 29 and 36 each recite a second portion of said device opening in each of lines 8 and 10. It is unclear if the second recitation is referring to the first recitation.
Each of claims 29 and 36 also recite said device opening is configured to both reduce and expand in diameter or cross-sectional area of the crimpable or plastically deformable portion of the medical device during operation of said crimping device. This limitation is awkwardly written so as to be confusing. For example, it is unclear what is meant by the following: said device opening configured to both reduce and expand … of the crimpable or plastically deformable portion.
Claims 30 and 36 each recite said first and section portions of said device opening. There is insufficient antecedent basis for section portions. It appears this should recite: said first and second portions of said device opening.
Claim 32 recites a crimper assembly. In light of Applicant’s originally filed disclosure it is unclear if this crimper assembly is the same as the crimping assembly introduced in claim 29. If not, what is different about this assembly?
Claim 35 recites said pin or flange. There is insufficient antecedent basis for this limitation.
Claim 37 recites a crimper assembly. In light of Applicant’s originally filed disclosure it is unclear if this crimper assembly is the same as the crimping assembly introduced in claim 36. If not, what is different about this assembly?
Claim 39 recites said first and second outer plates are rotatably connected to a support assembly; said first outer plate and said second outer plate are non-moveably connected to said support assembly. It is unclear how the outer plates can be rotatably connected to the support assembly and non-moveably connected to the support assembly. It appears this limitation should recite: said first and second outer plates are rotatably connected to a support assembly; said first inner plate and said second inner plate are non-moveably connected to said support assembly.
Claim 42 recites said pin or flange from one of said jaws of said first set of jaws, and said pin or flange of each of said jaws of said second set of jaws. There is insufficient antecedent basis for each of “said pin or flange”.
The rest of the claims are rejected for depending from at least one of the above claims.
Rejections under 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.
(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 29 and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by USPGPub No. 2023/0110138 (“Loughnane”).
Regarding claim 29, Loughnane teaches a crimper device that is configured to crimp a crimpable or plastically deformable portion of a medical device (¶ [0002]); said crimping device includes a crimping assembly (100) that has a device opening (figs. 1-3, ¶ [0046]); said device opening is configured to receive a portion or all of the crimpable or plastically deformable portion of the medical device (fig. 9, ¶ [0087]); said device opening is configured to both reduce and expand in diameter or cross-sectional area of the crimpable or plastically deformable portion of the medical device during operation of said crimping device (figs. 9-12, ¶ [0087] & [0098]-[0100]).
Claim 29 also recites a first portion of said device opening is configured to a) reduce in diameter or cross-sectional area at a different rate as compared to a second portion of said device opening during said operation of said crimping device, and/or b) begin reducing in diameter or cross-sectional area at a different time as compared to a second portion of said device opening during said operation of said crimping device. Loughnane teaches a first portion of the opening being formed by a first plurality of jaws 124 and a second portion of the opening being formed by a second plurality of jaws 144 (figs. 3 & 8, ¶ [0055] & [0064]). The first and second jaws are configured so that they are movable independently of each other by actuating respective handles 121 & 141 (figs. 1-3 & 11, ¶ [0049]-[0050], [0076] & [0099]). Thus, the first portion of the device opening is at least capable of reducing in diameter at a different rate and at a different time as compared to the second portion by actuating the handles 121 & 141 at a different time and/or at a different speed. Further, the first and second plurality of jaws are connected to one another via fasteners 160 (figs. 2-3, ¶ [0051], [0056] & [0065]). At least a portion of the jaws slide radially inward and outward with respect to one another via flexing/bending of hinges 123/125 (fig. 4, ¶ [0056]-[0057] & [0078]).
Loughnane further teaches said device opening has a longitudinal length along a longitudinal axis of said device opening; said first portion of said device opening constitutes 0.1-70% of said longitudinal length of said device opening; said second portion of said device opening constitutes 0.1-70% of said longitudinal length of said device opening (fig. 8, ¶ [0107]).
Claim 30 recites said first and section portions of said device opening are positioned adjacent to one another or are spaced from one another along said longitudinal axis of said device opening. As illustrated in figures 3 & 8, the first and second jaws are spaced from each other via spacer plate 130.
Rejections under 35 USC 1032
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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious3 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 31 and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Loughnane.
Claim 31 recites said crimping assembly includes a first set of jaws (124) and a second set of jaws (144) (figs. 3 & 8, ¶ [0055] & [0064]); said first set of jaws includes first and second jaws (fig. 3); said second set of jaws includes first and second jaws (fig. 3). Claim 31 also recites said first jaw of said first and second set of jaws are slidably connected to one another to enable said first jaw of said first and second set of jaws to independently move with respect to one another while being connected to one another; said second jaw of said first and second set of jaws are slidably connected to one another to enable said second jaw of said first and second set of jaws to independently move with respect to one another while being connected to one another. As detailed above, the first and second jaws are independently movable via respective handles. They are also connected to one another via fasteners 160 (figs. 2-3, ¶ [0051], [0056] & [0065). At least a portion of the jaws slide radially inward and outward with respect to one another via flexing/bending of hinges 123/125 (fig. 4, ¶ [0056]-[0057] & [0078]).
Since there is a spacer plate 130 between the first and second jaws, Loughnane fails to explicitly teach said first jaw of said first and second set of jaws are positioned adjacent to one another; said second jaw of said first and second set of jaws are positioned adjacent to one another. However, this would have been obvious in view of Loughnane. Loughnane teaches that the spacer plate 130 may be removed (¶ [0062]). Loughnane teaches other embodiments wherein the axial length of the crimping opening may be reduced when compressing shorter stents by removing elements (¶ [0062]). Thus, when crimping a shorter stent than the one illustrated in fig. 9, it would be obvious to remove the spacer plate 130 so that the first and second jaws are adjacent to each other. Removing the spacer plate will allow the device to still function as intended since actuating the handles 121 & 141 will still reduce/increase the diameter of the opening formed by the plurality of jaws.
Regarding claim 36, Loughnane teaches a crimper device that is configured to crimp a crimpable or plastically deformable portion of a medical device (¶ [0002]); said crimping device includes a crimping assembly (100) that has a device opening (figs. 1-3, ¶ [0046]); said device opening is configured to receive a portion or all of the crimpable or plastically deformable portion of the medical device (fig. 9, ¶ [0087]); said device opening is configured to both reduce and expand in diameter or cross-sectional area of the crimpable or plastically deformable portion of the medical device during operation of said crimping device (figs. 9-12, ¶ [0087] & [0098]-[0100]).
Claim 36 also recites a first portion of said device opening is configured to a) reduce in diameter or cross-sectional area at a different rate as compared to a second portion of said device opening during said operation of said crimping device, and/or b) begin reducing in diameter or cross-sectional area at a different time as compared to a second portion of said device opening during said operation of said crimping device. Loughnane teaches a first portion of the opening being formed by a first plurality of jaws 124 and a second portion of the opening being formed by a second plurality of jaws 144 (figs. 3 & 8, ¶ [0055] & [0064]). The first and second jaws are configured so that they are movable independently of each other by actuating respective handles 121 & 141 (figs. 1-3 & 11, ¶ [0049]-[0050], [0076] & [0099]). Thus, the first portion of the device opening is at least capable of reducing in diameter at a different rate and at a different time as compared to the second portion by actuating the handles 121 & 141 at a different time and/or at a different speed.
Loughnane further teaches said crimping assembly includes a first set of jaws (124) and a second set of jaws (144) (figs. 3 & 8, ¶ [0055] & [0064]); said first set of jaws includes first and second jaws (fig. 3); said second set of jaws includes first and second jaws (fig. 3). Claim 36 further recites said first jaw of said first and second set of jaws are slidably connected to one another to enable said first jaw of said first and second set of jaws to independently move with respect to one another while being connected to one another; said second jaw of said first and second set of jaws are slidably connected to one another to enable said second jaw of said first and second set of jaws to independently move with respect to one another while being connected to one another. As detailed above, the first and second jaws are independently movable via respective handles. They are also connected to one another via fasteners 160 (figs. 2-3, ¶ [0051], [0056] & [0065). At least a portion of the jaws slide radially inward and outward with respect to one another via flexing/bending of hinges 123/125 (fig. 4, ¶ [0056]-[0057] & [0078]).
Since there is a spacer plate 130 between the first and second jaws, Loughnane fails to explicitly teach said first jaw of said first and second set of jaws are positioned adjacent to one another; said second jaw of said first and second set of jaws are positioned adjacent to one another. However, this would have been obvious in view of Loughnane. Loughnane teaches that the spacer plate 130 may be removed (¶ [0062]). Loughnane teaches other embodiments wherein the axial length of the crimping opening may be reduced when compressing shorter stents by removing elements (¶ [0062]). Thus, when crimping a shorter stent than the one illustrated in fig. 9, it would be obvious to remove the spacer plate 130 so that the first and second jaws are adjacent to each other. Removing the spacer plate will allow the device to still function as intended since actuating the handles 121 & 141 will still reduce/increase the diameter of the opening formed by the plurality of jaws.
Given the above modification that positions the first and second plurality of jaws adjacent to each other, the following limitation is also met: said first and section portions of said device opening are positioned adjacent to one another or are spaced from one another along said longitudinal axis of said device opening.
Regarding claim 37, Loughnane further teaches a crimper assembly; said crimper assembly includes a first inner plate (150) (fig. 3), and a second inner plate (fig. 3, i.e. plate with hole 112 and fasteners 160 extending therefrom); said first inner plate engages each of said jaws of said first set of jaws of said crimping assembly (figs. 2-3 & 8, wherein plate 150 is abutted/engaged with ring 120 including first jaws 124); each of said jaws of said first set of jaws are independently movable relative to said first inner plate (at least a portion of the jaws slide radially inward and outward with respect to the inner plate via flexing/bending of respective hinges 123/125—see fig. 4, ¶ [0056]-[0057] & [0078]); said second inner plate engages each of said jaws of said second set of jaws of said crimping assembly (figs. 2-3 & 8, wherein ring 140 and second jaws thereof is abutted/engaged with the second plate); each of said jaws of said second set of jaws are independently movable relative to said second inner plate (at least a portion of the jaws slide radially inward and outward with respect to the inner plate via flexing/bending of respective hinges 123/125—see fig. 4, ¶ [0056]-[0057] & [0078]); said first inner plate is positioned on one side of said crimping assembly and said second inner plate is positioned on an opposite side of said crimping assembly (see figs. 3 & 8, wherein the assembly can be interpreted as the inner plates and rings 120/130/140).
Allowable Subject Matter
Claims 32-35 and 38-43 would be allowable if rewritten 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 and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kyle Cook whose telephone number is 571-272-2281. The examiner’s fax number is 571-273-3545. The examiner can normally be reached on Monday-Friday 9AM-5PM EST.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner's supervisor Thomas Hong (571-272-0993). The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A COOK/Primary Examiner, Art Unit 3726
1 The following conventions are used in this office action. All direct quotations from claims are presented in italics. All information within non-italicized parentheses and presented with claim language are from or refer to the cited prior art reference unless explicitly stated otherwise.
2 In 103 rejections, when the primary reference is followed by “et al.”, “et al.” refers to the secondary references. For example, if Jones was modified by Smith and Johnson, subsequent recitations of “Jones et al.” mean “Jones in view of Smith and Johnson”.
3 Hereafter all uses of the word “obvious” should be construed to mean “obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.”
Prosecution Insights