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(s) (IDS) submitted on 11/27/2024 has been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 204, 206, 208 and 210 in Figure 29; and 306 and 308 in Figure 30. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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 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 limitation(s) is/are: “an actuation device” in claims 1 and 17.
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 11-16 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 claim 11 (and thereby dependent claims 12-16), the phrase "a release layer" in line 4 renders the claim(s) indefinite because a release layer was already introduced in line 3, thereby rendering the scope of the claim(s) unascertainable. It is unclear whether applicant intended to refer back to the release layer of line 3 or introduce a new, additional release layer. To move prosecution forward, the examiner assumed applicant intended to refer back to the release layer of line 3. Appropriate correction is required.
Regarding claim 11 (and thereby dependent claims 12-16), the phrase "a polyimide structural layer" in line 5 renders the claim(s) indefinite because a polyimide structural layer was already introduced in line 3, thereby rendering the scope of the claim(s) unascertainable. It is unclear whether applicant intended to refer back to the polyimide structural layer of line 3 or introduce a new, additional polyimide structural layer. To move prosecution forward, the examiner assumed applicant intended to refer back to the polyimide structural layer of line 3. Appropriate correction is required.
Regarding claim 11 (and thereby dependent claims 12-16), the phrase "a release layer" in line 5 renders the claim(s) indefinite because a release layer was already introduced in line 3, thereby rendering the scope of the claim(s) unascertainable. It is unclear whether applicant intended to refer back to the release layer of line 3 or introduce a new, additional release layer. To move prosecution forward, the examiner assumed applicant intended to refer back to the release layer of line 3. Appropriate correction is required.
Regarding claim 11 (and thereby dependent claims 12-16), the phrase "a conduction layer" in line 7 renders the claim(s) indefinite because a conduction layer was already introduced in line 3, thereby rendering the scope of the claim(s) unascertainable. It is unclear whether applicant intended to refer back to the conduction layer of line 3 or introduce a new, additional conduction layer. To move prosecution forward, the examiner assumed applicant intended to refer back to the conduction layer of line 3. Appropriate correction is required.
Regarding claim 11 (and thereby dependent claims 12-16), the phrase "a microactuator" in line 7 renders the claim(s) indefinite because a microactuator system was already introduced in line 1, thereby rendering the scope of the claim(s) unascertainable. It is unclear whether applicant intended to refer back to the microactuator system of line 3 or introduce a new, additional microactuator. To move prosecution forward, the examiner assumed applicant intended to refer back to the microactuator system of line 1. Appropriate correction is required.
Regarding claim 15, the phrase "a polyimide structural layer" in line 1 renders the claim(s) indefinite because a polyimide structural layer was already introduced in line 3 of claim 11, thereby rendering the scope of the claim(s) unascertainable. It is unclear whether applicant intended to refer back to the polyimide structural layer of claim 11 or introduce a new, additional polyimide structural layer. To move prosecution forward, the examiner assumed applicant intended to refer back to the polyimide structural layer of claim 11. Appropriate correction is required.
Regarding claim 15, the phrase "a release layer" in lines 1-2 renders the claim(s) indefinite because a release layer was already introduced in line 3 of claim 11, thereby rendering the scope of the claim(s) unascertainable. It is unclear whether applicant intended to refer back to the release layer of claim 11 or introduce a new, additional release layer. To move prosecution forward, the examiner assumed applicant intended to refer back to the release layer of claim 11. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) 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.
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) 1-4, 7-9, 11, 14-15 and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (US 2020/0155820).
Lee discloses (see Fig. 2) a microactuator system and method for clearing drainage devices and method of manufacture comprising the following claim limitations:
(claim 1) A self-clearing system comprising: a microactuator (10, Fig. 2) including a polyimide structural layer ([0022]; [0025]-[0026]; polyimide layer expressly disclosed) and a conduction layer ([0025]; gold-containing conduction layer expressly added to the microactuator), the polyimide structural layer having a main body (16, Fig. 2) and a flexure (14, Fig. 2), the flexure (14) coupled to the main body (16) at a first terminal end (i.e., distal end of flexure 14 joining to body 16) of the flexure (14) (as shown in Fig. 2), the conduction layer is coupled to the polyimide structural layer ([0025]; gold-containing conduction layer expressly added to a polyimide layer); a catheter lumen (12, Fig. 2) coupled to the microactuator (10) (as shown in Fig. 1A; see claim 8; [0005]-[0006]; [0012]; [0014]; [0018]; [0023]; [0026]-[0027]; [0029]; microactuator expressly disclosed to fit inside and be attach to catheter lumen), the catheter lumen is configured to accept the microactuator (10) (as shown in Fig. 1A; see claim 8; [0005]-[0006]; [0012]; [0014]; [0018]; [0023]; [0026]-[0027]; [0029]; microactuator expressly disclosed to fit inside and be attach to catheter lumen); and an actuation device (24, Fig. 2) (i.e., magnetic field generating device) configured to (i.e., capable of) wirelessly engage the microactuator (10) (see claim 2; [0012]-[0014]; [0023]; magnetic deflection expressly disclosed);
(claim 2) wherein the microactuator (10) is coupled to the catheter (12) lumen by a second terminal end (at 20) of the flexure (14) (as shown in Fig. 2);
(claim 3) wherein the flexure is substantially pliable ([0007]; [0009]; [0023]; deflection/flexing of the flexure is expressly disclosed);
(claim 4) wherein the flexure has a rectangular cross-sectional shape (as shown in Fig. 2; [0023]; rectangular cross-sectional shape expressly disclosed);
(claim 7) wherein the conduction layer includes a gold material ([0025]; gold-containing conduction layer expressly added to the microactuator);
(claim 8) wherein the conduction layer is coupled to the polyimide structural layer by electroplating with a solution that includes at least one of nickel sulfamate, boric acid, and/or sodium dodecyl sulfate ([0025]; gold-containing conduction layer expressly added to the a polyimide layer) (it is noted that the device of Lee, et al. appear to be substantially identical to the device claimed, although produce by a different process (i.e., interpreted as a product-by-process claim), therefore the burden is upon the applicant to come forward with evidence establishing an unobvious difference between the two. In re Marosi, 218 USPQ 289 (Fed. Cir. 1983); see MPEP 2113, 2173.05(p));
(claim 9) wherein the actuation device includes a magnet (see claim 2; [0012]-[0014]; [0023]; [0027]; use of a magnet to induce deflection of the flexure is expressly disclosed);
(claim 11) A method of manufacturing a microactuator system (as shown in Figs. 1A-2) configured to remove a blood clot, the method comprising the steps of: providing a base layer ([0025]; providing a base silicon wafer layer expressly disclosed), a release layer ([0025]; depositing a release layer onto the base layer expressly disclosed), a polyimide structural layer ([0025]; depositing a polyimide layer onto the release layer expressly disclosed), and a conduction layer ([0025]; depositing a gold-containing conduction layer expressly disclosed); disposing a release layer on the base layer ([0025]; depositing a release layer onto the base layer expressly disclosed); disposing a polyimide structural layer on a release layer ([0025]; depositing a polyimide layer onto the release layer expressly disclosed); etching the polyimide structural layer ([0025]; polyimide layer etching expressly disclosed); and coupling a conduction layer on the polyimide structural layer ([0025]; depositing a gold-containing conduction layer onto a polyimide layer expressly disclosed), thus forming a microactuator (10);
(claim 14) wherein the step of coupling the conduction layer to the polyimide structural layer includes electroplating the conduction layer ([0025]; nickel electroplating the gold-containing conduction layer expressly disclosed);
(claim 15) wherein the step of disposing a polyimide structural layer on a release layer includes spin coating the polyimide structural layer ([0025]; spin coating the polyimide layer expressly disclosed);
(claim 17) A method of using a self-clearing system configured to remove a blood clot, the method comprising the steps of: providing a microactuator (10, Fig. 2) including a polyimide structural layer ([0022]; [0025]-[0026]; polyimide layer expressly disclosed) and a conduction layer ([0025]; gold-containing conduction layer expressly added to the microactuator), the polyimide structural layer having a main body (16, Fig. 2) and a flexure (14, Fig. 2), the flexure (14) coupled to the main body (16) at a first terminal end (i.e., distal end of flexure 14 joining to body 16) of the flexure (14) (as shown in Fig. 2), the conduction layer is coupled to the polyimide structural layer ([0025]; gold-containing conduction layer expressly added to a polyimide layer); disposing the microactuator (10) within a catheter lumen (12, Fig. 2) (as shown in Fig. 1A; see claim 8; [0005]-[0006]; [0012]; [0014]; [0018]; [0023]; [0026]-[0027]; [0029]; microactuator expressly disclosed to fit inside and be attach to catheter lumen); coupling a second terminal end of the flexure (14) to the catheter lumen (as shown in Fig. 1A; see claim 8; [0005]-[0006]; [0012]; [0014]; [0018]; [0023]; [0026]-[0027]; [0029]; microactuator expressly disclosed to fit inside and be attach to catheter lumen); and engaging the microactuator (10) wirelessly with an actuation device (24, Fig. 2) (see claim 2; [0012]-[0014]; [0023]; magnetic deflection expressly disclosed); and
(claim 18) wherein the actuation device includes a magnet which wirelessly engages the microactuator with a magnetic force (see claim 2; [0012]-[0014]; [0023]; [0027]; use of a magnet to induce deflection of the flexure via a magnetic force is expressly disclosed).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) 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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Dhuler et al. (CA 2332216) (copy provided herein).
Lee, as applied above, discloses a microactuator system and method for clearing drainage devices and method of manufacture comprising all the limitations of the claim except for the flexure having a curved/serpentine cross-sectional shape.
However, Dhuler teaches (see Figs. 1-2) a microactuator system (21) comprising a flexure (23/25) having a curved/serpentine cross-sectional shape (as shown in Fig. 1; see Abstract; serpentine flexure expressly taught) in order to beneficially increase overall deflection of the microactuator without increasing the length of the actuating segments while further reducing lateral displacement used to achieve the desired angular displacement (see Abstract; p. 2, lines 2-13; p. 3, lines 13-14; p. 5, line 27-p. 6, line 18). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device/method of Lee to have a flexure having a curved/serpentine cross-sectional shape in order to beneficially increase overall deflection of the microactuator without increasing the length of the actuating segments while further reducing lateral displacement used to achieve the desired angular displacement, as taught by Dhuler.
Allowable Subject Matter
Claims 10, 12-13, 16 and 19-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. It is noted that claims 12-13 and 16 remain subject to 112 rejections, as set forth above, which must be resolved before these claims can be rewritten in proper form for allowance.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see:
Bergsneider et al. (US 2008/0281250);
Judy et al. (US 2011/0313340); and
Lee et al. (US 2019/0307608)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771