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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/18/2026 has been entered.
Status of Claims
Claims 1-4 and 7-24 are pending, of which claims 14-16 and 22-24 are withdrawn. Therefore, claims 1-4, 8-13, and 17-21 are examined below.
Response to Arguments
The remarks of 02/18/2026 have been fully considered but they are not persuasive.
Applicant argues that the prior art of record doesn't explicitly teach or disclose all of the elements of amended claim 1, in particular the following claim limitations:
“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”
This argument is moot in light of the new 103 rejection below.
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)
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 a staging surface (Fig. 1C, 24) comprising a tear line (Fig. 1C, 21) configured for removing the staging surface from the container (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)
Furthermore, regarding claim 1, the claimed phrase “when the locking member is open again after closing” is being treated as a product-by-process limitation and a product-by-process claim is not limited to the manipulations of the recited steps, only the structure implied by the steps. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. MPEP 2113.
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), as applied 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.
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 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.
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 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
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 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)
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).
Furthermore, regarding claim 17, the claimed phrase “when the locking member is open again after closing” is being treated as a product-by-process limitation and a product-by-process claim is not limited to the manipulations of the recited steps, only the structure implied by the steps. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. MPEP 2113.
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), 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.
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 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.
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 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
Included below is relevant prior art that was considered but not relied upon for this office action:
US 4,994,056 (Ikeda) – discloses clamp 20 that separates two portions of the mixing system and can be resealed
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/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774