CTNF 19/029,296 CTNF 82403 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Objections 07-29-01 AIA Claim 20 is objected to because of the following informalities: claim 18 refers to a molded brush section defining a plurality of…brush sections and claim 20 then refers to the brush sections and the brush section. The Examiner assumes that the brush section is intended to be the molded brush section. If not, there is a clear 112b for not differentiating between the various brush sections . Appropriate correction is required. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15-aia AIA Claim s 18 and 20 are rejected under 35 U.S.C. 102 a1/a2 as being anticipated by By ers et al. (US 2010/0087705) . Regarding Claim 18 , Byers discloses: A biopsy cap (230) configured to be secured to a port of a medical device and to accommodate one or more elongate members therethrough, the biopsy cap comprising: an outer shell (236) securable to a port on the medical device and defining an interior volume between a proximal end of the outer shell and a distal end of the outer shell (see Fig. 4, for example, showing the proximal and distal ends of the shell with volume therebetween) ; and a molded brush section (244; see Paragraph 0100) defining a plurality of radially-inwardly extending separate brush sections (256; see Fig. 4) . Regarding Claim 20 , Byers further discloses wherein the brush sections are individually molded and joined together to form the brush section (product-by-process limitation that does not overcome the prior art; the final product of Byers is a brush section with multiple brush sections; these sections can be molded, see Paragraph 0100, and there is nothing structurally differentiating the claimed product and Byers) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim s 1-6 and 8-14 are rejected under 35 U.S.C. 103 as being unpatentable over Byers et al. (US 2010/0087705) in view of Hasson et al. (US 5,743,884) . Regarding Claim 1 , Byers discloses: A biopsy cap (230) configured to be secured to a port of a medical device, the biopsy cap comprising: an outer shell (236) having a proximal end, a distal end, and an interior volume defined within the outer shell between the proximal end and the distal end (see Fig. 4, for example, showing the proximal and distal ends of the shell with volume therebetween) ; and a brush section (244) disposed within the interior volume defined within the outer shell (see Fig. 4 showing 244 within the volume defined by 236) . Byers does not explicitly disclose the brush section including a plurality of brush layers stacked and arranged so that brushes of the stacked layers are arranged in a helical fashion. Hasson teaches a plurality of brush layers (272) stacked and arranged in a helical fashion (Col 11 Lines 16-19, the misalignment is the same manner of creating the helical nature of Applicant’s brush section; Fig. 14 also shows a helical configuration for the brush sections). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Byers’ device to have Hasson’s seal. Such a modification is the simple substitution of one known element for another to yield predictable results. Byers’ section 244 can be replaced with Hasson’s helically stacked bristle brush to perform the same function of forming a seal. Regarding Claim 2 , Byers as modified further discloses wherein each brush layer of the plurality of brush layers comprises a plurality of brushes spaced apart from one another (see Hasson Fig. 21 showing the brushes separated by slits 278) . Regarding Claim 3 , Byers as modified further discloses wherein each brush layer of the plurality of brush layers further comprises an outer annular ring (Hasson – 272) , the brushes extending radially inwardly from the outer annular ring (see Fig. 21, for example showing the brushes extending radially inwardly from ring 272) . Regarding Claim 4 , Byers as modified further discloses wherein each brush layer of the plurality of brush layers includes a plurality of individual brushes the individual brushes of each of the plurality of brush layers extending radially inwardly from the annular ring (see Hasson Figs. 20 and 21 showing individual brushes 280 extending radially inwardly from the ring 272) . Regarding Claim 5 , Byers as modified further discloses wherein the individual brushes of each of the plurality of brush layers are deflectable to enable an elongate member to extend through the brush section (see Hasson Fig. 20 showing the brushes deflecting as 180 is inserted therein; see also Col 11 Lines 13-14 discussing radial deformation; see also Col 10 Lines 46-51 discussing a similar embodiment and how the flaps bend downwardly) . Regarding Claim 6 , Byers as modified further discloses wherein the individual brushes are biased into contact with an elongate member extended through the brush section to help reduce or prevent fluid flow through the biopsy cap (see Hasson Figs. 20-21 showing the brushes in contact with an instrument 180; the brushes extend to the center of the disc such that they are biased to contact any instrument inserted therein) . Regarding Claim 8 , Byers discloses: A biopsy cap (230) configured to be secured to a port of a medical device, the biopsy cap comprising: an outer shell (236) defining an interior volume between a proximal end of the outer shell and a distal end of the outer shell (see Fig. 4, for example, showing the proximal and distal ends of the shell with volume therebetween) ; and a brush section (244) including a plurality of brushes (256) at least partially blocking fluid flow through the biopsy cap (the brushes are located in the interior volume of the shell so that they will block at least some fluid through the cap) . Byers does not explicitly disclose wherein the brushes are arranged in a helical fashion. Hasson teaches a plurality of brush layers (272) stacked and arranged in a helical fashion (Col 11 Lines 16-19, the misalignment is the same manner of creating the helical nature of Applicant’s brush section; Fig. 14 also shows a helical configuration for the brush sections). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Byers’ device to have Hasson’s seal. Such a modification is the simple substitution of one known element for another to yield predictable results. Byers’ section 244 can be replaced with Hasson’s helically stacked bristle brush to perform the same function of forming a seal. Regarding Claim 9 , Byers as modified further discloses wherein the plurality of brushes are spaced apart from one another (see Hasson Fig. 21 showing the brushes separated by slits 278) . Regarding Claim 10 , Byers as modified further discloses wherein the plurality of brushes extend radially inwardly and are deflectable to enable an elongate member to extend through the brush section (see Hasson Figs. 20 and 21 showing individual brushes 280 extending radially inwardly from the ring 272) , but are biased into contact with the elongate member to help reduce or prevent fluid flow through the biopsy cap (see Hasson Figs. 20-21 showing the brushes in contact with an instrument 180; the brushes extend to the center of the disc such that they are biased to contact any instrument inserted therein) . Regarding Claim 11 , Byers as modified further discloses wherein the brushes are configured to extend into a C-shape channel of an elongate member extended through the brush section (functional language; the brushes of Hasson are elongated such that they can extend into a channel of an inserted device) , and are arranged in a helical fashion to help accommodate twisting of the elongate member with the C-shape channel (the brushes are arranged helically as discussed above) . Regarding Claim 12 , Byers as modified further discloses wherein the brush section is annular and formed in radial sections (see Hasson Figs. 21 or 17 showing the rings, each ring has multiple brush elements such that each ring is considered to be formed in radial sections) . Regarding Claim 13 , Byers as modified further discloses wherein the brush section is formed of a linear brush section having a first free end and a second free end, the first free end and the second free end being joined together to form an annular brush section (Hasson discloses a ring as shown in Fig. 21; the claim is a product-by-process claim where the product is a ring, the process involves connected two free ends; this does not result in a different structure in the final product when compared to the prior art because in both the claim and the prior art, a completed ring is formed) . Regarding Claim 14 , Byers as modified further discloses wherein the brush section is formed by stacking together a plurality of individual brush layers (see Hasson Fig. 21) , each individual brush layer rotated relative to an adjacent brush layer to arrange the brushes of the plurality of individual brush layer in a helical fashion along the brush section (Col 11 Lines 16-19, the misalignment is the same manner of creating the helical nature of Applicant’s brush section) . 07-21-aia AIA Claim s 1-2, 7-12, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Byers et al. (US 2010/0087705) in view of Brockmeier et al. (US 2008/0290605) . Regarding Claim 1 , Byers discloses: A biopsy cap (230) configured to be secured to a port of a medical device, the biopsy cap comprising: an outer shell (236) having a proximal end, a distal end, and an interior volume defined within the outer shell between the proximal end and the distal end (see Fig. 4, for example, showing the proximal and distal ends of the shell with volume therebetween) ; and a brush section (244) disposed within the interior volume defined within the outer shell (see Fig. 4 showing 244 within the volume defined by 236) . Byers does not explicitly disclose the brush section including a plurality of brush layers stacked and arranged so that brushes of the stacked layers are arranged in a helical fashion. Brockmeier teaches using a similar seal in medical devices with a brush that is stacked and arranged in a helical fashion (see 500 in Figs. 12-13) to form a seal around an inserted instrument. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Byers’ device to have Brockmeier’s seal. Such a modification is the simple substitution of one known element for another to yield predictable results. Byers’ section 244 can be replaced with Brockmeier’s helically stacked bristle brush to perform the same function of forming a seal. Regarding Claim 2 , Byers as modified further discloses wherein each brush layer of the plurality of brush layers comprises a plurality of brushes spaced apart from one another (see Brockmeier Fig. 13, for example, showing the layers spaced apart; the Examiner also notes that the brush includes bristle members 502/504 where bristles have gaps between them; finally, Fig. 16 includes various brushes 804 that can be made from bristles (Paragraph 0040) where each section is separated by slits 806) . Regarding Claim 7 , Byers as modified further discloses wherein the plurality of brush layers are secured to each other and folded to form the brush section (see Brockmeier Figs. 12-13 showing the brush layers being folded in a helical pattern to form the seal; each layer is secured to each other as shown in Fig. 12) . Regarding Claim 8 , Byers discloses: A biopsy cap (230) configured to be secured to a port of a medical device, the biopsy cap comprising: an outer shell (236) defining an interior volume between a proximal end of the outer shell and a distal end of the outer shell (see Fig. 4, for example, showing the proximal and distal ends of the shell with volume therebetween) ; and a brush section (244) including a plurality of brushes (256) at least partially blocking fluid flow through the biopsy cap (the brushes are located in the interior volume of the shell so that they will block at least some fluid through the cap) . Byers does not explicitly disclose wherein the brushes are arranged in a helical fashion. Brockmeier teaches using a similar seal in medical devices with a brush that is stacked and arranged in a helical fashion (see 500 in Figs. 12-13) to form a seal around an inserted instrument. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Byers’ device to have Brockmeier’s seal. Such a modification is the simple substitution of one known element for another to yield predictable results. Byers’ section 244 can be replaced with Brockmeier’s helically stacked bristle brush to perform the same function of forming a seal. Regarding Claim 9 , Byers as modified further discloses wherein the plurality of brushes are spaced apart from one another (see Brockmeier Fig. 13, for example, showing the layers spaced apart; the Examiner also notes that the brush includes bristle members 502/504 where bristles have gaps between them; finally, Fig. 16 includes various brushes 804 that can be made from bristles (Paragraph 0040) where each section is separated by slits 806) . Regarding Claim 10 , Byers as modified further discloses wherein the plurality of brushes extend radially inwardly and are deflectable to enable an elongate member to extend through the brush section (see Brockmeier Figs. 12 and 13 showing individual brushes 504 extending radially inwardly from the ring 506) , but are biased into contact with the elongate member to help reduce or prevent fluid flow through the biopsy cap (see Brockmeier Figs. 10 showing the brushes in contact with an instrument “I”; the brushes extend to the center of the disc such that they are biased to contact any instrument inserted therein) . Regarding Claim 11 , Byers as modified further discloses wherein the brushes are configured to extend into a C-shape channel of an elongate member extended through the brush section (functional language; the brushes of Brockmeier are elongated such that they can extend into a channel of an inserted device) , and are arranged in a helical fashion to help accommodate twisting of the elongate member with the C-shape channel (the brushes are arranged helically as discussed above) . Regarding Claim 12 , Byers as modified further discloses wherein the brush section is annular and formed in radial sections (see Brockmeier Figs. 12-13 showing the annular shape when folded; each ring has multiple brush elements such that each ring is considered to be formed in radial sections) . Regarding Claim 15 , Byers as modified further discloses wherein the brush section is formed by a plurality of brush layers joined together via hinges and folded along the hinges to form the brush section (see Brockmeier Fig. 12 showing living hinges between the layers of brushes such that when folded the brush section is formed as shown in Fig. 13) . Regarding Claim 16 , Byers as modified further discloses wherein the layers are folded along the hinges in accordion fashion to form the brush section (see Brockmeier Fig. 12 showing the accordion fashion of the brush section in the unfolded or partially folded state and Fig. 13 showing the accordion fashion in the compressed) . Regarding Claim 17 , Byers as modified further discloses wherein the layers are arranged and secured together in a two-dimensional arrangement and are sequentially folded along the hinges to form the brush section (this is a product-by-process limitation describing how the brush section is formed; Brockmeier’s brush section can be arranged in a line and then spirally folded as shown in Fig. 12 one spiral at a time until the section is finally formed as shown in Fig. 13) . Allowable Subject Matter 12-151-08 AIA 07-43 12-51-08 Claim 19 is 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. 13-03-01 AIA The following is a statement of reasons for the indication of allowable subject matter: The primary reason the claims are allowable over the prior art is that the prior art fails to disclose or render obvious the claimed molded brush section. The fact that this is molded does play a role. The claim requires this molded brush section to have a linear shape with a first and second end. These ends are joined and upon joining the bristle sections extend radially-inwardly in a helical fashion. Hasson’s configuration includes a spiral as shown in Fig. 14, but the ends of the linear shape are never connected as claimed (this is also true of Brockmeier Figs 12-13). Hasson’s discs can be formed by joining two free ends, but for Hasson that would not result in the creation of a helix as claimed. Instead, Hasson requires multiple discs to be stacked in an offset or misaligned manner to create the claimed helical fashion. The claim is narrower and requires that the bristle sections be in a helical fashion upon or when the first end and the second end are joined. That is simply not the case with the prior art. There being no teaching to place multiple bristles on a single disc in a helical pattern, the Examiner considers the limitation to overcome the prior art . Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY JAY NEAL whose telephone number is (313)446-4878. The examiner can normally be reached Mon-Fri 7:30-5:30. 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, Anhtuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795 Application/Control Number: 19/029,296 Page 2 Art Unit: 3795 Application/Control Number: 19/029,296 Page 3 Art Unit: 3795 Application/Control Number: 19/029,296 Page 4 Art Unit: 3795 Application/Control Number: 19/029,296 Page 5 Art Unit: 3795 Application/Control Number: 19/029,296 Page 6 Art Unit: 3795 Application/Control Number: 19/029,296 Page 7 Art Unit: 3795 Application/Control Number: 19/029,296 Page 8 Art Unit: 3795 Application/Control Number: 19/029,296 Page 9 Art Unit: 3795 Application/Control Number: 19/029,296 Page 10 Art Unit: 3795 Application/Control Number: 19/029,296 Page 11 Art Unit: 3795 Application/Control Number: 19/029,296 Page 12 Art Unit: 3795
Prosecution Insights