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 .
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.
Election/Restrictions
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-8, drawn to a handle, classified in A61F 2/9517.
II. Claims 9-19, drawn to a delivery apparatus, classified in A61F 2/95.
III. Claim 20, drawn to a method for implanting a prosthetic implant, classified in A61F 2/2327.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the combination as claimed does not require the handle comprising at least one window and at least one indicator positioned adjacent to the window. The subcombination has separate utility such as with a medical cutting tool.
The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Inventions I and III are related to product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product as claimed can be used in a materially different process. For example, the handle can be used with a delivery device for insertion through a different body part, such as the abdomen, instead of the vasculature.
Inventions II and III are directed to as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product as claimed can be used in a materially different process. For example, the delivery device can be used with a delivery device for insertion through a different body part, such as the abdomen, instead of the vasculature.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions or processes have acquired a separate status in the art in view of their different classification, the inventions have acquired a separate status in the art due to their recognized divergent subject matter, and/or the inventions require a different field of search (for example, searching different classes/subclasses or electronic resourced, or employing different search queries).
During a telephone conversation with Linda Nassif on 08/20/2026 a provisional election was made without traverse to prosecute the invention of a handle, claims 1-8. Affirmation of this election must be made by applicant in replying to this Office action. Claims 6-20 are withdrawn from further consideration as being drawn to a non-elected invention.
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.
Claims 1-5 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Semisynov (US PG Pub No. 2020/0146856 A1).
Regarding claim 1, Semisynov discloses a handle (Paragraph [0023], Figs. 1-4) for a delivery apparatus (Fig. 4, delivery system 10), the handle comprising: a housing (Figs. 1-4, housing 1) having an outer wall (Fig. 1, see annotated Fig. 4 below); at least one window (Fig. 1, window 7) coupled to the outer wall of the housing (Fig. 1, see annotated Fig. 4 below), the at least one window (7) defining at least one viewing region (Paragraph [0181], “clear window”) through the outer wall (Fig. 1, see annotated Fig. 4 below); and at least one indicator (see annotated Fig. 4 below) positioned within the housing (1) adjacent (Fig. 4) to the window (7), the at least one indicator including a background member (Fig. 4, runner’s position scale 6) and a slider (Fig. 4, runner 13 and runner arrow 17), wherein the slider (13 and 17) is configured to slide (Paragraph [0187]) relative to the background member (6).
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Regarding claim 2, Semisynov discloses wherein the slider (13 and 17) includes an opening (Fig. 5, see annotated Fig. 4 above), and wherein the background member (6) extends through the opening of the slider (13 and 17).
Regarding claim 3, Semisynov discloses wherein the slider (13 and 17) includes a viewable portion (Fig. 4, runner arrow 17) that is positioned between the background member (6) and the window (7).
Regarding claim 4, Semisynov discloses wherein the background member (6) is fixed (Fig. 4, 6 is not a part of the slider (seen in Fig. 5) but attached to housing in Fig. 4) relative to the housing (1).
Regarding claim 5, Semisynov discloses wherein the at least one window (7) includes a frame (Figs. 1-4, see annotated Fig. 4 below) and a windowpane (Figs. 1-4, see annotated Fig. 1 below) coupled (Fig. 1) to the frame (Figs. 1-4, see annotated Fig. 4 below).
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Regarding claim 8, Semisynov discloses further comprising an adjustment mechanism (Figs. 1-4, screw rotating wheel 11) operatively connected to the slider (Fig. 4, runner 13 and runner arrow 17), wherein the slider (13 and 17) is configured to indicate an amount of adjustment (Paragraph [0187]) by the adjustment mechanism (Figs. 1-4, screw rotating wheel 11).
Claim Rejections - 35 USC § 103
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.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Semisynov (US PG Pub No. 2020/0146856 A1), as applied to claims 1 and 5 above, and in view of Manash et al. (US PG Pub No. 2018/0263764 A1).
Regarding claim 6, Semisynov fails to disclose wherein the frame defines two viewing regions, wherein each viewing region is associated with a different measurement indicated by the at least one indicator. Manash also discloses a handle (Fig. 8, handle 420) for a delivery apparatus (Fig. 8, delivery catheter 410) comprising a window (Paragraph [0080], indicators 422a and 424a “can be windows”) including a frame (see annotated Fig. 8 below). Manash teaches wherein the frame (see annotated Fig. 8 below) defines two viewing regions (Paragraph [0080], 422a and 424a “can be windows”), wherein each viewing region (422a and 424a) is associated with a different measurement (Paragraph [0080], Fig. 8, indicator 422a for control 422 and indication 424a for control 424) indicated by the at least one indicator (422a and 424a). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the handle of Semisynov wherein the frame defines two viewing regions, wherein each viewing region is associated with a different measurement indicated by the at least one indicator, as taught by Manash, in order to have more precise control (Paragraph [0080]).
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Regarding claim 7, Semisynov discloses wherein a first window (Fig. 1, window 7) is positioned on a first side (see annotated Fig. 1 below) of the handle (Paragraph [0023], Figs. 1-4) but fails to disclose wherein a second window is positioned on a second, opposite side of the handle. Manash also discloses a handle (Fig. 8, handle 420) for a delivery apparatus (Fig. 8, delivery catheter 410) comprising a first window (Paragraph [0080], indicator 422a “can be windows”) positioned on a first side of the handle (distal side). Manash teaches a second window (Paragraph [0080], indicator 424a “can be windows”) positioned on a second, opposite side of the handle (the proximal side). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the handle of Semisynov wherein the handle comprises a second window positioned on a second, opposite side of the handle, as taught by Manash, in order to have more precise control (Paragraph [0080]).
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Rupp et al. (US PG Pub No. 2020/0214840 A1) also discloses a handle (Fig. 2, handle 20) for a delivery apparatus (Fig. 2, delivery apparatus 10), the handle comprising: at least one window (Fig. 2, window 92), and at least one indicator (Fig. 2, indicator 91).
Berra et al. (US Patent No. 9,364,314 B2) also discloses a handle (Fig. 28, handle 2430) for a delivery apparatus (Figs. 31-32, delivery system 2400), the handle comprising: at least one window (Figs. 31-32, window 3200), and at least one indicator (Col. 18, lines 59-63).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARI L COCHRAN whose telephone number is (571)272-9637. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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 Tyson can be reached at 5712729062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.L.C./ Patent Examiner, Art Unit 3774
/MELANIE R TYSON/ Supervisory Patent Examiner, Art Unit 3774
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