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 .
Priority
This application claims priority from 63/469121, filed 05/26/2023
Status of Claims
Claims 1-7 are pending.
Information Disclosure Statement
The Information Disclosure Statement filed on 09/18/2024 has been considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the bore comprising a noncircular cross-section of the deflector nut (claim 1, 119 shown in Figure 4 does not include an opposing side to provide a bore, 119 is only depicted on one side of the sleeve 115 so there is no bore present) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Specification
The abstract of the disclosure is objected to because it fails to meet the 50 word minimum and is not sufficiently descriptive. The abstract must better describe the applicant’s invention. In its current form it merely says the invention is a delivery system. The applicant is advised to amend the abstract to include more elements from independent claim 1. Correction is required. See MPEP § 608.01(b).
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.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. § 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that § 112(f) (pre-AIA § 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. § 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that § 112(f) (pre-AIA § 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke § 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke § 112(f) except as otherwise indicated in an Office action.
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.
Claim 6 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 6 requires an audible feedback generator, but the original disclosure fails to provide any specifics as to how the audible feedback is generated.
In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is "reasonable" or is "undue." Consistent with Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023), the Wands factors continue to provide a framework for assessing enablement in a utility application or patent, regardless of technology area. See Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al., 89 FR 1563 (January 10, 2024). The 8 factors are listed below with a corresponding analysis relating them to the clause at hand.
(A) The breadth of the claims; claim 6 requires a mechanism that generates audible feedback in response to deflection of the steerable catheter, which does not define the type of mechanism, how the feedback is generated, the type of audible feedback, or how the deflection is detected.
(B) The nature of the invention; the invention is a system for delivering a prosthetic aortic valve, which are very complex devices with small tolerances because of their compact size, this type of invention is also limited by requirements for biocompatibility and highly reliability standards
(C) The state of the prior art; the prior art is a highly technical field because it is related to minimally invasive heart surgery which does not lend itself to general or quick fixes
(D) The level of one of ordinary skill; a person of ordinally skill would include surgeons, biologists, and engineers, which define a high level of skill and knowledge but it does not inherently provide the skill with audible background
(E) The level of predictability in the art; the prior art is a highly technical field which does not lend itself to general or quick fixes, adding an audible mechanism would require substantial prior knowledge and an experimentation to fit an additional mechanism within the existing structure
(F) The amount of direction provided by the inventor; the original disclosure does not depict the audible feedback generator in the figures and only mentions it in the specification [0004] and [0049]. There are no details, just a general statement saying that the invention may include the audible feedback generator.
(G) The existence of working examples; the disclosure provided no examples and the use of audible feedback generators are not a commonly claimed aspect to heart valve delivery systems
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure, to make the applicant’s invention include an additional audible feedback generator would require substantial experimentation including at least determining what type of mechanism is used, how the feedback will be generated, the type of audible feedback, how the deflection is detected by the generator, how the generator will be powered, where the generator will be positioned, and what materials would be biocompatible and reliable enough to be used.
Therefore the addition or use of an audible feedback generator was not described in the specification in such a way as to enable one skilled in the art of heart valve delivery systems and any art which it is nearly connected, to make and/or use the invention.
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 1-7 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.
Independent claim 1 is rendered indefinite by the deflection nut to have a bore with a non-circular bore. This clause is not considered new matter because it is present within an original claim, but the original figures and specification do not clarify how or where the non-circular bore is. The original disclosure generally states the presence of a non-circular bore in [0006] and [0028]. Reference number 119 is described as being the deflection nut, which is only shown in Figure 4. The figures only show nut as a single elongated portion in the cutaway figure. They do not include an opposing side to define the other end or side of the bore and the space where it should be is filled with pull wire 164. Therefore there is no bore present. Additionally, it is unclear, if there actually is a bore, if it is non-circular. The definition of circular includes any rounded shape related to a circle. Therefore if the cross-section of the bore is an oval, elliptical, or rounded at all it would fail to meet the requirement for it being non-circular.
Allowable Subject Matter
The closest prior art is cited in the attached form 892. The prior art of record fails to disclose or render obvious a medical delivery system comprising both a steerable and balloon catheter with pull wires, pull rods, and a handle comprising a housing, traveler guide shafts, a deflection nut with a non-circular bore, two knobs, and a locking mechanism. Additionally, the closest prior art fails to disclose the second knob is configured to rotate the balloon catheter pull rod and the balloon catheter while allowing the balloon catheter pull rod to longitudinally translate in relation to the second rotatable actuator knob when the locking mechanism is in the unlocked position.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774
Prosecution Insights