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 .
Response to Arguments
Applicant’s replacement drawings have overcome the previous drawing objections.
Applicant's amendment and arguments filed 4/20/2026 have been fully considered but they are not persuasive. Applicant has amended the claims to replace “driving assembly” with “driving mechanism”; to replace the “delivery assembly” with “delivering clamping fixture”; to replace “second and third rotating assemblies” with “first and second rotating assemblies”; to replace “third rotating and delivery assembly” with “rotating and delivering assembly”; and to replace “rapid exchange delivering assembly” with “rapid exchange catheter clamping fixture”.
With respect to the claimed “driving mechanism”, Applicant argues par. [0036] of the specification indicates each driving mechanism comprises a lead screw motor. However, the portion of par. [0036] that mentions “lead screw motor” states “The second driving mechanism 2 is driven to displace by a driving device (for example, a linear module, a lead screw motor, or the like).” In other words a driving device that drives the second driving mechanism 2 could include a lead screw motor and not the second driving mechanism itself. The lead screw motor is a structure that acts on the second driving mechanism 2 and is clearly described as a separate structure from the second driving mechanism 2. This is further illustrated by the claim construction in which “a second driving mechanism” comprises “a first rotating assembly” and “a second delivering clamping fixture”. If the second driving mechanism were a lead screw motor as argued, what part of this motor is the “first rotating assembly” and what part of this motor is “the second delivering clamping fixture” that make up the second driving mechanism in the claim? It appears the second driving mechanism is some different structure that is not clearly defined or described in the specification. The rejection is maintained.
Regarding the term “clamping fixture”, Applicant argues that with respect to Fig. 4, “It is obvious that each delivering assembly is a clamping fixture composed of dual-cylinder pneumatic clamping plates”. The Examiner respectfully disagrees. Nothing in the specification indicates there are dual-cylinder pneumatic clamping plates as argued. Applicant points to a structure in Fig. 4 but the particular structure is not described in the specification; a link of that particular part of the figure to the claimed ”clamping fixture” is never made (support for the term “clamping fixture” was not found in the originally filed disclosure) and no meaningful determination of the particular construction of the structure can be discerned from a single, top-down view of the structure. The rejection is maintained.
Regarding the term “first and second rotating assemblies”, Applicant argues Fig. 5 shows “each rotating assembly comprises gears and components cooperated with the gears” and then notes “that such structures are common structure sin the prior art, which can be understood by those skilled in the art and can be realized by many other rotating structures”. First, MPEP §2181, III states:
“The corresponding structure, material, or acts may be disclosed in the original drawings, figures, tables, or sequence listing. However, the corresponding structure, material, or acts cannot include any structure, material, or acts disclosed only in the material incorporated by reference or a prior art reference. See Pressure Prods. Med. Supplies, Inc. v. Greatbatch Ltd., 599 F.3d 1308, 1317, 94 USPQ2d 1261, 1267 (Fed. Cir. 2010) (stating, "[s]imply mentioning prior art references in a patent does not suffice as a specification description to give the patentee outright claim to all of the structures disclosed in those references."); Atmel Corp. v. Info. Storage Devices, Inc., 198 F.3d 1374, 1381, 53 USPQ2d 1225, 1230 (Fed. Cir. 1999). The disclosure must be reviewed from the point of view of one skilled in the relevant art to determine whether that person would understand the written description to disclose the corresponding structure, material, or acts. Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1338, 88 USPQ2d 1865, 1879 (Fed. Cir. 2008); Med. Instrumentation & Diagnostics Corp. v. Elekta AB, 344 F.3d 1205, 1211-12, 68 USPQ2d 1263, 1269 (Fed. Cir. 2003). To satisfy the definiteness requirement under 35 U.S.C. 112(b) or 35 U.S.C. 112, second paragraph, the written description must clearly link or associate the corresponding structure, material, or acts to the claimed function. Telcordia Techs., Inc. v. Cisco Systems, Inc., 612 F.3d 1365, 1376, 95 USPQ2d 1673, 1682 (Fed. Cir. 2010). A rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph is appropriate if the written description fails to link or associate the disclosed structure, material, or acts to the claimed function, or if there is no disclosure (or insufficient disclosure) of structure, material, or acts for performing the claimed function. Donaldson, 16 F.3d at 1195, 29 USPQ2d at 1850. A bare statement that known techniques or methods can be used would not be a sufficient disclosure to support a means-plus-function limitation. Biomedino, LLC v. Waters Techs. Corp., 490 F.3d 946, 953, 83 USPQ2d 1118, 1123 (Fed. Cir. 2007).”
In the instant case, the Examiner notes the term “gear” is never associated in the specification or drawings with term “rotating assembly”. The term “gear” never actually appears in the specification. While Fig. 5 clearly shows a set of gears, the line pointing to this structure is labeled in the spec as a “T-valve 211”. The “second rotating assembly” 21 is pointing to some other, unnamed structure entirely separate from the illustrated gears in Fig. 5. With respect to the assertion that such assemblies are well-known as supported by the IDS, the Examiner notes “…the corresponding structure, material, or acts cannot include any structure, material, or acts disclosed only in the material incorporated by reference or a prior art reference” .The Examiner further notes the claims states the “first rotating assembly is configured to clamp a second end of the first medical instrument”; it is unclear how a stand-alone gear would clamp anything as gears are not commonly understood as lamping features. Lastly, it is unclear what other “components” as argued by Applicant would be considered part of the claimed rotating assemblies. The rejection is therefore maintained.
Regarding the “rotating and delivering assembly”, Applicant indicated Fig. 6 shows this structure and that the assembly is “a composite structure composed of gears” and then noted par. [0040] of the specification was amended to indicate it can be a gear box. The Examiner notes such an amendment to the specification is improper and introduces new matter. The Examiner further notes the originally field disclosure does not associate gears or any other particular structure with the claimed “rotating and delivering assembly”. The rejection is therefore maintained.
Specification
The amendment filed 4/20/2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: The various mentions of “clamping fixture”; “cancellation of this rotating and delivering assembly” that is replaced with simply “rotating and delivering assembly”; and the addition of “gear box” to par. [0040]. In summary the entirety of the changes in the specification amendment received 4/20/2026 are improper.
Applicant is required to cancel the new matter in the reply to this Office Action.
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:
Claim 1
“a first driving mechanism…wherein the first medical instrument… are delivered and rotated by using the first driving mechanism…”
“a first delivering clamping fixture…configured to clamp one end of a first medical instrument and deliver the first medical instrument”
“a second driving mechanism… wherein the first medical instrument… are delivered and rotated by using the… second driving mechanism…”
“a first rotating assembly…configured to clamp a second end of the first medical instrument and rotate the first medical instrument”
“a second delivering clamping fixture…configured to clamp a first end of a second medical instrument and deliver the second medical instrument”
“a third driving mechanism… wherein the first medical instrument… are delivered and rotated by using the… third driving mechanism…”
“a rotating and delivering assembly…configured to clamp a third medical instrument…”
“a second rotating assembly…configured to clamp a second end of the second medical instrument”
“a third delivering clamping fixture…configured to clamp the third medical instrument…”
Claim 5
“a rapid exchange catheter clamping fixture, configured to clamp and deliver a rapid exchange catheter”
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.
The “first driving mechanism” fails to have any particular structure associated with it in the specification. It will be interpreted as any structure capable of the claimed function.
The “first delivering clamping fixture” is not disclosed in the originally file disclosure. It will be interpreted as any structure capable of the claimed function.
The “second driving mechanism” fails to have any particular structure associated with it in the specification. It will be interpreted as any structure capable of the claimed function.
The “first rotating assembly” is not disclosed in the originally filed disclosure. It will be interpreted as any structure capable of the claimed function.
The “second delivering clamping fixture” is not disclosed in the originally file disclosure. It will be interpreted as any structure capable of the claimed function.
The “third driving mechanism” fails to have any particular structure associated with it in the specification. It will be interpreted as any structure capable of the claimed function.
The “second rotating assembly” is disclosed as including a “rotating unit” in par. [0036]. However, “unit” is also a nonce term modified by the functional language “rotating”. There is no clear structure that represents the term “second rotating assembly”. It will be interpreted as any structure capable of the claimed function.
The “rotating and delivering assembly” is disclosed as having “a complicated structure. Specifically,the third rotating and delivering assembly 31 includes a rotating unit 311 and a delivering unit 312. The rotating unit 311 and the delivering unit 312 are assembly to an integral structure, or the rotating unit 311 and the delivering unit 312 are separately arranged.” The terms “unit” are nonce terms only modified by functional language “rotating”, “delivering”. There is no clear structure that represents the term “a third rotating and delivery assembly”. It will be interpreted as any structure capable of the claimed function.
The “third delivering clamping fixture” is not disclosed in the originally file disclosure. It will be interpreted as any structure capable of the claimed function.
The “rapid exchange catheter clamping fixture” is not disclosed in the originally file disclosure. It will be interpreted as any structure capable of the claimed function.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Throughout the claims, the various “clamping fixtures” lack support in the originally filed disclosure.
Regarding Claim 1, the following lacks adequate structure in the specification: “a first driving mechanism”; “a first delivering clamping fixture”; “a second driving mechanism”; “a first rotating assembly”; “a second delivering clamping fixture”; “a third driving mechanism”; “a rotating and delivering assembly”; “a second rotating assembly”; and “a third delivering clamping fixture”. See MPEP §2181, IV: “A means- (or step-) plus-function limitation that is found to be indefinite under 35 U.S.C. 112(b) based on failure of the specification to disclose corresponding structure, material or act that performs the entire claimed function also lacks adequate written description…”.
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 1-20 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 1, the claim limitations “a first driving mechanism”; “a first delivering clamping fixture”; “a second driving mechanism”; “a first rotating assembly”; “a second delivering clamping fixture”; “a third driving mechanism”; “a rotating and delivering assembly”; “a second rotating assembly”; and “a third delivering clamping fixture” invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. There are no clear structural Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
In light of the claim issues under 35 USC 112(b) and 112(a), the Examiner notes there are currently no prior art rejections applied. As noted in MPEP §2173.06, II: “Second, where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 103 should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims.” Therefore, the lack of applied art is not an admission of allowability and is instead indicative of the inability to provide a clear and proper claim interpretation for the claimed structure.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLEN PORTER whose telephone number is (571)270-5419. The examiner can normally be reached Mon - Fri 9:00-6:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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