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 .
Status of Claims
Claims 1-4 and 7-24 are pending, of which claims 14-16 and 21-24 are withdrawn. Therefore, claims 1-4, 7-13, and 17-20 are examined below.
Response to Arguments
The remarks of 07/06/2026 have been fully considered but they are not persuasive.
Applicant argues that the prior art doesn't explicitly teach or disclose all of the elements of newly amended claims 1 and 17, in particular applicant argues the following claim language:
the locking member comprising a first locking member and a second locking member integrally formed with respective upper and layers of the container such that the first locking member and the second locking member engage each other to form a closed position and disengage each other to form an open position, wherein each oft he first and second locking members comprises a continuous interlocking profile extending along opposing edges of the container
wherein upon a removal ofthe staging surface from the container, the locking member remains on the distal end ofthe container and the container is configured to receive the bone material and/or fluid onto the interior surface after the removal of the staging surface.
These arguments are moot in light of the new 103 rejection below.
Claim Objections
Regarding claim 17, the claim as amended reads “respective upper and layers of the container”. Examiner believes this should read “respective upper and lower layers of the container”
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.
Claim(s) 1-4, 9-11, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0000062 A1 (Chen) in view of US 2004/0011678 (Ramet) in view of US 6,648,133 (Blaschke) in view of US 2021/0269213 (Burley)
Regarding claim 1, Chen discloses a container for mixing a bone material (Figs. 7A-7B), the container comprising:
an interior surface (Fig. 7A, wherein flexible pouch 1 has an interior surface) configured for receiving the bone material thereon (¶0072, wherein tissue or cellular material can be loaded into 1, see also ¶0046, wherein the tissue can be bone)
an exterior surface having a distal end and a proximal end (see Fig. 7A, wherein flexible pouch 1 has an exterior surface with a proximal and distal end), the distal end comprising a locking member (Fig 7A, 36) configured to enclose the bone material onto the interior surface of the container (¶0072, wherein 36 is configured for this intended use), the proximal end of the exterior surface having a port (Fig. 7A, 2) configured to receive fluid (¶0073, “cellular material and/or biological fluids”) to mix with the bone material on the interior surface of the container (¶0073, wherein fluid can be injected into 1 through 2) or withdraw the bone material mixed with fluid on the interior surface from the container (¶0035, wherein biological solutions may be removed or injected via 2)
wherein the exterior surface further comprises a staging surface (Fig. 7a, 33) adjacent to the locking member (Fig. 7a, wherein 33 is adjacent to 36) to receive and/or measure the bone material for entry of the bone material onto the interior surface (¶0072, wherein 33 is configured for this intended use because tissue and/or cellular material may be loaded into the pouch through 33) when the locking member is in an open position (Fig. 7A, wherein 36 is shown in the open position)
Chen discloses a staging surface (Fig. 7a, 33) but doesn't explicitly teach or disclose a tear line adjacent to the locking member and configured for removing the staging surface from the container.
Ramet discloses wherein the staging (Fig. 1C, 24) surface is removable from the container along the tear line (Fig. 3A, wherein 21 is configured for this intended use because 24 is removed from 22).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify Chen in view of Ramet with a tear line, as taught by Ramet, in order to eliminate the need for additional tools to separate the two portions of the container.
Chen doesn't explicitly teach or disclose “when the locking member is open, a portion of the interior surface and a portion of the staging surface form into a single surface on the same plane, and when the locking member is open again after sealing, the portion of the interior surface and the portion of the staging surface form into the single surface again”. Ramet doesn't explicitly teach or disclose when the locking member is open, a portion of the interior surface and a portion of the staging surface form into a single surface on the same plane, and when the locking member is open again after sealing, the portion of the interior surface and the portion of the staging surface form into the single surface again.
Blaschke discloses a package for hydrating orthopedic material (Fig. 6) wherein when the locking member is open (Fig. 4, wherein 14 corresponds to the locking member and is shown in the open position), a portion of the interior surface (Fig. 6, wherein 38 corresponds to a portion of the interior surface) and a portion of the staging surface (Fig. 6, wherein 40 corresponds to a portion of the staging surface form) into a single surface on the same plane (Fig. 7, wherein 38 and 40 form a single coplanar surface when 14 is open, see also Col. 7, Lines 28-32), and when the locking member is open again after sealing , the portion of the interior surface and the portion of the staging surface form into the single surface again (see Figs 4 and 5, wherein 14 forms a interference fit and therefore it configured for this intended use, see also Col. 6, Lines 6-14)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the container for mixing bone material of Chen in view of Ramet with a locking member, as taught by Blaschke, in order to provide in situ mixing of the two components (Col. 7, Lines 4-5)
Chen doesn't explicitly teach or disclose a locking member comprising a first locking member and a second locking member as claimed or wherien upon removal of the staging surface from the container, the locking member remains on the distal end of the container and the container is configured to receive the bone material and/or fluid onto the interior surface after removal of the staging surface. Ramet doesn't explicitly teach or disclose a locking member comprising a first locking member and a second locking member as claimed or wherien upon removal of the staging surface from the container, the locking member remains on the distal end of the container and the container is configured to receive the bone material and/or fluid onto the interior surface after removal of the staging surface Blaschke doesn't explicitly teach or disclose a a locking member comprising a first locking member and a second locking member as claimed or wherien upon removal of the staging surface from the container, the locking member remains on the distal end of the container and the container is configured to receive the bone material and/or fluid onto the interior surface after removal of the staging surface
Burley discloses a container for storing tissue comprising
a locking member (Fig. 3, 210) comprising a fist locking member and a second locking member (¶0062, “material pressed against a corresponding surface) integrally formed with respective upper and layers of the container (¶0062, wherein “a self-sealing zipper mechanism is understood to be internally formed with the upper and lower layers) such that the first locking member and the second locking member engage each other to form a closed position and disengage each other to form an open position (¶0062, wherein the seal sealing zipper mechanism is resealable), wherein each of the first and second locking members comprises a continuous interlocking profile extending along opposing side of the container (see Fig. 3, wherein 210 extends along opposing sides of the container) and
wherien upon a removal of the staging surface from the container (¶0068, wherien tear notes 270 and opening portion 271 on either side of the opening), the locking member remains on the distal end of the container (see Fig. 3, wherien the locking member 210 is positioned on the distal end of container relative to 270/271) and the container is configured to receive the bone material and/or fluid onto the interior surface after the remoal of the staging surface (¶0062, wherien a multi-use self-sealing mechanism is configured for this intended use)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the locking member of surface of Chen in view of Ramet in view of Blaschke with a first locking member and a second locking member that is integrally formed, resealable, and extends along opposing edges of the container, as taught by Burley, in order to limit penetration of microbes (¶0007)
Regarding claim 2, Chen discloses wherein the port (Fig. 7A, 2) comprises a channel to allow fluid onto or out of the interior surface of the container (¶0040, wherein valve 4 within connector 2 allows for fluid to be exchanged freely)
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Regarding claim 3, Chen discloses wherein (ii) the port (Fig. 2A, 2) has a fitting configured to engage a syringe (¶0035, wherein a luer lock adapter corresponds to a fitting configured to engage a syringe)
Regarding claim 4, Chen further discloses wherein the locking member (Fig. 7A, 36) (i) encloses the bone material onto the interior surface of the container when in a closed position (See Fig. 7B for closed position, see also ¶0072, wherein 36 seals bone material into pouch 1) and allows the bone material entry onto the interior surface of the container when in an open position (see Fig. 7A for open position, ¶0071, wherein bone material is loaded into 1 when in the open position); or (ii) comprises a first locking member disposed on the exterior surface and a corresponding locking member disposed on the interior surface to allow a seal between the exterior surface and the interior surface when the respective locking members are engaged to prevent loss of bone material or fluid mixed with the bone material from the container
Regarding claim 9, Chen discloses wherein (ii) the bone material (¶0110, bone chips) comprises ceramic, collagen. allograft bone, autograft bone, demineralized bone matrix fibers, demineralized bone powder. demineralized bone chips or a combination thereof (¶0110, wherein bone chips correspond to demineralized bone chips)
Regarding claim 10, Chen discloses wherein the fluid (¶0037, wherein the biological solution corresponds to the fluid) comprises bone marrow aspirate, saline, sterile water, blood for injection, phosphate buffered saline, dextrose, Ringer's lactated solution, or a combination thereof (¶0037, “bone marrow aspirate”).
Regarding claim 11, Chen discloses wherein (i) the proximal end of the container (1, Fig. 7A) comprises a neck (see annotated Fig. A below, see also ¶0032, wherein 3 is sealed at an angle to avoid dead space)
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Regarding claim 13, Chen discloses wherein the port (Fig. 7A, 2) is configured to receive a syringe (¶0035, wherein 2 is configured for this intended use because it is connected to a luer lock adapter) for addition of fluid to the container or precise dispensing of bone material from the container (¶0035, wherein 2 may be used to remove or inject any biological solutions)
Claim(s) 7, 8, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0000062 A1 (Chen) in view of US 2004/0011678 (Ramet) in view of US 6,648,133 (Blaschke) in view of US 2021/0269213 (Burley), as applied to claims above and further in view of US 2020/0008921 (Alden)
Regarding claim 7, Chen doesn’t explicitly teach or disclose an upper and lower layer. Ramet doesn’t explicitly teach or disclose an upper and lower layer. Blaschke doesn't explicitly teach or disclose an upper layer having the exterior surface and a lower layer having the interior surface. Burley doesn't explicitly teach or disclose an upper layer having the exterior surface and a lower layer having the interior surface.
Alden discloses comprising an upper layer (Fig. 4, 110) having the exterior surface and a lower layer (Fig. 4, 120) having the interior surface (see Fig. 4, wherein 120 has an interior surface).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify Chen in view of Ramet in view of Blaschke in view of Burley with an upper layer and lower layer, as taught by Alden, in order to quickly and easily access the mixed bone material without the need for additional tools.
Regarding claim 8, Chen doesn’t explicitly teach or disclose an upper and lower layer. Ramet doesn’t explicitly teach or disclose an upper and lower layer. Blaschke doesn't explicitly teach or disclose the particulars of the upper and lower layer as claimed. Burley doesn't explicitly teach or disclose the particulars of the upper and lower layer as claimed.
Aldean discloses wherein: (i) the upper layer (Fig. 4, 110) is peelable away from the lower layer (¶0043, wherein 110 is peelable) and in a direction towards the distal end of the container (Fig. 4, wherein 110 is peelable towards the distal end of 105) to allow access to any bone material and/or fluid on the interior surface of the container (Fig. 4, wherein the upper and lower layer are configured for this intended use);
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify Chen in view of Ramet in view of Blaschke in view of Burley with an upper layer peelable away from the lower layer as taught by Aldean, in order to quickly and easily access the mixed bone material without the need for additional tools
Regarding claim 12, Chen discloses a container (see rejection of claim 1) but doesn’t explicitly teach or disclose flexible sidewalls. Ramet doesn't explicitly teach or disclose flexible sidewalls. Blaschke doesn't explicitly teach or disclose flexible sidewalls. Burley doesn't explicitly teach or disclose flexible sidewalls.
Aldean discloses a container comprises flexible sidewalls (Fig. 3, 103, ¶0045, wherein the desired flexibility is maintained) configured to allow manual mixing of fluid and the bone material on the interior surface by pressure applied by hand (¶0045, wherein side edges 103 are configured for this intended use because they are both flexible and sealed together)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify Chen in view of Ramet in view of Blaschke in view of Burley with flexible sidewalls, as taught by Aldean, in order to provide further structural integrity to the container while maintaining flexibility.
Claim(s) 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over 2016/0000062 A1 (Chen) in view of US 2019/0106254 (Weimer) in view of US 6,648,133 (Blaschke) in view of US 2021/0269213 (Burley)
Regarding claim 17, Chen discloses a container for mixing a bone material (Fig. 7a), the container comprising:
an interior surface (Fig. 7A, wherein flexible pouch 1 has an interior surface) configured for receiving bone material thereon (Fig. 7A, wherein flexible pouch 1 is configured for this intended use) and an exterior surface having a distal end and a proximal end (Fig. 7A, wherein flexible pouch 1 has an exterior surface with a distal end and proximal end), the distal end of the exterior surface comprising a header portion (Fig. 7A, 33) having an opening configured to allow loading of bone material onto the interior surface of the container (¶0072, wherein bone is loaded into 33 and then into container 1), the header portion disposed adjacent to a locking member (See Fig. 7A, wherein 33 is adjacent 36), which is disposed on the exterior surface or interior surface of the container (Fig. 7A, wherein 36 is disposed on the exterior surface of container 1),
the locking member (Fig. 7A, 36) being resealable such that the locking member allows adding the bone material when the locking member is open again after closing (Fig. 7a, ¶0072, wherein 36 is threaded and therefore resalable and configured for this intended use of adding bone material)
the proximal end of the exterior surface having a port (Fig. 7A, 2) configured to receive fluid to mix with the bone material on the interior surface of the container (¶0073, wherein fluid can be injected into 1 through 2) or withdraw bone material mixed with fluid on the interior surface from the container (¶0035, wherein biological solutions may be removed or injected via 2).
Chen discloses a header portion (Fig. 7A, 33) but doesn’t explicitly teach or disclose that the header portion (Fig. 4, 400) is more porous the proximal end of the exterior surface.
Weimer discloses a container (Fig. 1, 100) comprising a header portion (Fig. 4, 400) which is more porous that the proximal end of the exterior surface (¶0064, wherein 400 is more porous relative to the rest of the 100 because it has pores sized between 0.1- 0.5 microns)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the header portion of Chen i to be more porous than the proximal end of the exterior surface, as taught by Weimer, in order to dry the material out more quickly.
Chen doesn't explicitly teach or disclose “when the locking member is open, a portion of the interior surface and a portion of the staging surface form into a single surface on the same plane, and when the locking member is open again after sealing, the portion of the interior surface and the portion of the staging surface form into the single surface again, when the locking member is open, a portion of the interior surface and a portion of the staging surface form into a single surface on the same plane, and when the locking member is open again after sealing, the portion of the interior surface and the portion of the staging surface form into the single surface again”. Weimer doesn't explicitly teach or disclose when the locking member is open, a portion of the interior surface and a portion of the staging surface form into a single surface on the same plane, and when the locking member is open again after sealing, the portion of the interior surface and the portion of the staging surface form into the single surface again.
Blaschke discloses a package for hydrating orthopedic material (Fig. 6) wherein when the locking member is open (Fig. 4, wherein 14 corresponds to the locking member and is shown in the open position), a portion of the interior surface (Fig. 6, wherein 38 corresponds to a portion of the interior surface) and a portion of the staging surface (Fig. 6, wherein 40 corresponds to a portion of the staging surface form) into a single surface on the same plane (Fig. 7, wherein 38 and 40 form a single coplanar surface when 14 is open, see also Col. 7, Lines 28-32), and when the locking member is open again after sealing , the portion of the interior surface and the portion of the staging surface form into the single surface again (see Figs 4 and 5, wherein 14 forms a interference fit and therefore it configured for this intended use, see also Col. 6, Lines 6-14)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the container for mixing bone material of Chen in view of Weimer with a locking member, as taught by Blaschke, in order to provide in situ mixing of the two components (Col. 7, Lines 4-5)
Chen doesn't explicitly teach or disclose the particulars of a first and second locking member as claimed. Weimer doesn't explicitly teach or disclose the particulars of a first and second locking member as claimed. Blascke doesn't explicitly teach or disclose doesn't explicitly teach or disclose the particulars of a first and second locking member as claimed.
Burley discloses a locking member (Fig. 3, 210) comprises a first locking member integrally formed with an upper layer of the container and a second locking member integrally formed with a lower layer of the container (¶0062, “material pressed against a corresponding surface), the first locking member and the second locking member being configured to engage and disengage each other to selectively form a sealed condition (¶0063, see also Fig. 6), a sliding member extending along the first and second locking members and configured to translate relative to the fist and second locking members to effect engagement and disengagement of the locking member (¶0053, wherien a “locking or one-way member to prevent the one ore more sealing mechanism form being reopened” corresponds to the claimed sliding member)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the locking member of Chen in view of Weimer in view of Blascke with a first locking member, a second locking member, and a sliding mechanism, as taught by Burley, in order to limit penetration of microbes (¶0007)
Regarding claim 18, Chen discloses wherein the header portion has a first seal (Fig. 7A, wherein 35 corresponds to a first seal) configured to be applied to the container after the bone material comprising the wet bone material is loaded into the interior surface of the container (¶0072, wherein “tissue or cellular material is loaded into pouch and sealed”)
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over 2016/0000062 A1 (Chen) in view of US 2019/0106254 (Weimer) in view of US 6,648,133 (Blaschke) in view of US 2021/0269213 (Burley), as applied to claims above, and further in view of US 2004/0011678 (Ramet)
Regarding claim 19, Chen discloses wherein the bone material comprises dry bone materials (¶0046, wherein the material may be dry bone) formed from the wet bone material configured to be dried in the interior surface of the container, (Per MPEP 2113, “formed from the wet bone material configured to be dried in the interior surface of the container” is being treated as a product-by-process limitation therefore determination of patentability is based on the product, i.e. dry bone materials)
Chen discloses a header portion (Fig. 4, 400) but doesn't explicitly teach or disclose a header portion that is porous relative to the remainder of the container.
Weimer discloses a container (Fig. 1A, 100) comprising a header portion (Fig. 4, 400) that is porous relative to a remainder of the container (¶0064, wherein 400 is more porous relative to the rest of the 100 because it has pores between 0.1microns and 0.5 microns)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the header portion of Chen to be porous relative to the remainder of the container, as taught by Weimer, in order to dry the material within the container.
Chen discloses a first seal (Fig. 7A, 35) but doesn’t explicitly teach or disclose a second seal. Weimer doesn’t explicitly teach or disclose a second seal. Blaschke doesn’t explicitly teach or disclose a second seal. Burley doesn't explicitly teach or disclose a second seal
Ramet discloses a container (Fig. 1C, 1) comprising a second seal (Fig. 1C, 21) spaced from the first seal (Fig. 1C, 23).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the container of Chen in view of Weimer in view of Blaschke in view of Burley with a second seal, as taught by Ramet, in order to prevent cross contamination between the two containers.
Regarding claim 20, Chen discloses a header portion (Fig. 7A, 33) but doesn’t explicitly teach or disclose that it is configured to be removed from the remainder of the container after the second seal is applied to the container. Weimer doesn’t explicitly teach or disclose a header portion configured to be removed from the remainder of the container after the second seal is applied to the container. Blaschke doesn’t explicitly teach or disclose a header portion configured to be removed from the remainder of the container after the second seal is applied to the container. Burley doesn't explicitly teach or disclose a header portion configured to be removed from the remainder of the container after the second seal is applied to the container.
Ramet discloses a container (Fig. 1C) comprising a header portion (Fig. 1C, 24 which is configured to be removed from the remainder of the container after the second seal (Figs. 1C and 3A, 20) is applied to the container (see Fig. 3A, wherein the header portion 24 is removed after seal 20 is applied)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the header portion of Chen in view of Weimer in view of Blaschke in view of Burley to be removable after the second seal is applied to the container, as taught by Ramet, in order to prevent cross contamination between the two portions of the container.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAXIMILIAN TOBIAS SPENCER whose telephone number is (571)272-8382. The examiner can normally be reached M-F 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408.918.7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
