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 .
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) 31, 32, 34-44, 46, 47, 49, and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greener et al (US 2011/0319804) in view of Kuzmin (US 2009/0117311).
Regarding Claim 31, Greener discloses a wound closure device (¶ [0001-0005]) comprising:
a plurality of segments (individual cubic portions 12, Figs. 4 and 5) configured to be attached to each other to form an assembled structure (body 10, Figs. 4 and 5; the cubic portions are attached to each other through frangible regions 20; although the building blocks are manufactured attached to one another, they still read on the claims as written as the building blocks are not required to be separate prior to attachment) configured for placement in a wound (¶ [0074]; the body is used as wound packing); and
wherein individual segments (12, Figs. 4 and 5) comprise a plurality of walls (as seen in Figs. 4 and 5, the each segment is cuboidal with 6 walls).
Greener is silent whether each segment comprises an attachment element, the segment reversibly securable to the assembled structure such that the segment is configured to be removed from the assembled structure and re-secured to the assembled structure by the attachment element.
Kuzmin teaches interlocking elements, thus being in the same field of endeavor of modular building blocks, where each cell (block as seen in Fig. 20) comprises an attachment element (protrusions, Fig. 20) on a wall of a cell (Fig. 20; the actual cube portion is the cell), the cell reversibly securable to the assembled structure such that the cell is configured to be removed from the assembled structure and re-secured to the assembled structure by the attachment element (¶ [0010, 0113]). The blocks of Kuzmin allow for easy attachment and detachment while also providing a strong assembled construction (¶ [0164]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the segments of Greener to be the shape of the segments of Kuzmin Fig. 20 to comprise an attachment element positioned on the segment, the segment able to be removed from the assembled structure and re-secured to the assembled structure by the attachment element, as taught by Kuzmin (Fig. 20). Kuzmin states that the attachment structures provide for easy attachment and detachment of blocks while still providing for a strong assembled construction (¶ [0164]), which would improve the customization of the dressing of Greener by allowing segments to be removed and reattached as needed without negatively impacting the strength of the assembled device.
Regarding Claim 32, the combination of Greener/Kuzmin, as set forth above for Claim 31, teaches that the one or more building segments (cubic portions 12 of Greener that have been modified to have the shape, and therefore the protrusions and depressions, of Kuzmin Fig. 20) comprises receiving elements (depressions, Fig. 20 of Kuzmin) configured to receive the attachment elements (protrusions, Fig. 20 of Kuzmin) of one or more of the building blocks (12, Fig. 4, Greener; Fig. 20, Kuzmin; ¶ [0010, 0113, 0164] of Kuzmin).
Regarding Claim 34, Greener further discloses individual segments (12, Figs. 4 and 5) comprise one or more cells (12, Figs. 4 and 5) provided in a single row (each segment is comprised of one cell that can be interpreted as in a single row).
Regarding Claim 35, Greener further discloses individual segments (12, Figs. 4 and 5) comprise a cell (12, Figs. 4 and 5) having a uniform shape and size (each segment is the same size cube).
Regarding Claim 36, Greener further discloses individual segments (12, Figs. 4 and 5) consist of one cell (12, Figs. 4 and 5).
Regarding Claim 37, Greener further discloses individual segments (12, Figs. 4 and 5) comprise at least one cell having a quadrilateral shape (a cube is formed by 6 square sides, and each square is a quadrilateral).
Regarding Claim 38, Greener further discloses individual segments (12, Figs. 4 and 5) comprise a porous material (¶ [0072]).
Regarding Claim 39, Greener further discloses individual segments (12, Figs. 4 and 5) comprise foam (¶ [0072]).
Regarding Claim 40, Greener further discloses individual segments (12, Figs. 4 and 5) comprise precuts (14, 16, 18, Figs. 4 and 5) defining frangible portions (20, Figs. 4 and 5).
Regarding Claim 41, Greener further discloses one individual segments (12, Figs. 4 and 5) are configured to be cut or torn (¶ [0076] removing by hand is tearing away).
Regarding Claims 42-44, Greener further discloses a source of negative pressure, a drape, and a port, where the port is configured to transmit negative pressure through the drape placed over the wound (¶ [0003-0005]; the body 10 can be used with NPWT which uses a negative pressure source and a drape).
Regarding Claim 46, Greener discloses a method of closing a wound (¶ [0001-0005]), comprising:
positioning an assembled structure (10, Figs. 4 and 5) within a wound (¶ [0074]), the assembled structure (10, Figs. 4 and 5) comprising a plurality of segments (12, Figs. 4 and 5) configured to be attached to each other (each segment is attached to one another during manufacturing); and
wherein individual segments (12, Figs. 4 and 5) comprise a plurality of walls (as seen in Figs. 4 and 5, each segment is cuboidal with 6 walls).
Greener is silent whether each segment comprises an attachment element, the segment reversibly securable to the assembled structure such that the segment is configured to be removed from the assembled structure and re-secured to the assembled structure by the attachment element.
Kuzmin teaches interlocking elements, thus being in the same field of endeavor of modular building blocks, where each cell (block as seen in Fig. 20) comprises an attachment element (protrusions, Fig. 20) on the cell (Fig. 20; the actual cube portion is the cell), the cell reversibly securable to the assembled structure such that the cell is configured to be removed from the assembled structure and re-secured to the assembled structure by the attachment element (¶ [0010, 0113]). The blocks of Kuzmin allow for easy attachment and detachment while also providing a strong assembled construction (¶ [0164]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the segments of Greener to be the shape of the segments of Kuzmin Fig. 20 to comprise an attachment element positioned on the segment, the segment able to be removed from the assembled structure and re-secured to the assembled structure by the attachment element, as taught by Kuzmin (Fig. 20). Kuzmin states that the attachment structures provide for easy attachment and detachment of blocks while still providing for a strong assembled construction (¶ [0164]), which would improve the customization of the dressing of Greener by allowing segments to be removed and reattached as needed without negatively impacting the strength of the assembled device.
Regarding Claim 47, the combination of Greener/Kuzmin, as set forth above for Claim 46, teaches that the one or more building segments (cubic portions 12 of Greener that have been modified to have the shape, and therefore the protrusions and depressions, of Kuzmin Fig. 20) comprises receiving elements (depressions, Fig. 20 of Kuzmin) configured to receive the attachment elements (protrusions, Fig. 20 of Kuzmin) of one or more of the building blocks (12, Fig. 4, Greener; Fig. 20, Kuzmin; ¶ [0010, 0113, 0164] of Kuzmin).
Regarding Claim 49, Greener further discloses individual segments (12, Figs. 4 and 5) comprise one or more cells (12, Figs. 4 and 5) provided in a single row (each segment is comprised of one cell that can be interpreted as in a single row).
Regarding Claim 50, Greener further discloses individual segments (12, Figs. 4 and 5) comprise a cell (12, Figs. 4 and 5) having a uniform shape and size (each segment is the same size cube).
Claims 33, 45, and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Greener et al (US 2011/0319804) in view of Kuzmin (US 2009/0117311) further in view of Saxby (WO 2015/110409).
Regarding Claims 33 and 48, Greener/Kuzmin is silent whether each of the segments has an elongate shape with a uniform width.
Saxby teaches a wound filler made of repeating units (302, Fig. 5A) which have an elongate shape with a uniform width (as seen in Fig. 5A).
Therefore, it would have been obvious to substitute the shape of the segments of Greener/Kuzmin for the elongate shape with uniform width of Saxby, as Saxby shows that wound fillers made with elongate, repeating units were known in the art. This would result in a rectangular prism shaped building unit rather than the cuboidal shaped building unit of Greener/Kuzmin.
Regarding Claim 45, Greener/Kuzmin is silent regarding an organ protection layer.
Saxby teaches a wound filler with an organ protection layer (¶ [0147]) which protects the bottom layer of the wound from the negative pressure applied to the wound filler (¶ [0147]).
Therefore, it would have been obvious to modify the wound filler of Greener/Kuzmin to include an organ protection layer, as motivated by Saxby, to protect the bottom layer of the wound from the negative pressure applied to the wound filler (as motivated by Saxby ¶ [0147]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 31-47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 and 20 of U.S. Patent No. 12,097,096. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are merely narrower than the pending claims (since the patented claims recite the attachment element located on the wall and an opening extending through the top and bottom ends of the segments), making the patented claims a species of the pending claims’ genus. Since it has been held that the species anticipates the genus, the patented claims anticipate the pending claims.
Claims 31-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-16 of U.S. Patent No. 11,607,344. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are merely narrower than the pending claims (since the patented claims recite the attachment element located on the wall and an opening extending through the top and bottom ends of the segments, as well as referring to the segments as building blocks or building units and indicating that the assembled structure exhibits anisotropic behavior), making the patented claims a species of the pending claims’ genus. Since it has been held that the species anticipates the genus, the patented claims anticipate the pending claims.
Conclusion
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781
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