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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 25th, 2025 has been entered.
Response to Arguments
The rejection of claim 11 under 35 U.S.C. 112(b) is withdrawn.
Applicant's arguments filed November 25th, 2025 have been fully considered but they are not persuasive.
The Applicant argues that an advantage offered by the contoured prongs is particularly important when handling compositions comprising viable cells or biologically active materials, as maximum dispersion and uniformity can be achieved with little or no damage to the composition (Remarks, page 6). However, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
It is noted that some of the components in the cited references, such as collagen, undergo grinding (Moreau et al., page 2 and page 3) or milling and are suitable for long term storage (e.g. Temple, Abstract and para. [0011]) and would not be expected to be damaged by the mixing devices of the cited art. Further, the references disclose manual mixing and the force applied may be adjusted as needed to account for any sensitive ingredients and it is not clear why the prongs of Bidoia would cause more damage than those of the Applicant’s. The Applicant's position on this point is considered to be speculative attorney's argument unsupported by objective technical evidence on the issue. Arguments of counsel cannot take the place of evidence in the record. See In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Pearson, 494 F.2d 1399, 1405, 181 USPQ 641, 646 (CCPA 1974).
The Applicant argues that Bidoia’s prongs do not follow the internal contour of a mixing chamber having a conical bottom as Bidoia’s prongs are straight and not contoured to a mixing chamber having a conical bottom (Remarks, page 6). The Examiner respectfully disagrees. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In this case, it seems the prongs of Bidoia still broadly meet the claim limitation as they run parallel to the sidewall and have an angled feature in the conical portion (contours shown below traced with dotted lines):
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Thus, the argument is not persuasive.
The Applicant argues that there would be no expectation of success and a person of ordinary skill in the art would not have had a reasonable expectation of success that using a mixing blade comprising a plurality of prongs following the internal contour of the mixing chamber having a conical bottom, would be effective in mixing a composition as demonstrated in the present application (Remarks, page 7-8). The Examiner respectfully disagrees. Sand discloses a manual mixing device (Fig. 13) for bone cement (“bone filling material”, Abstract) where the amount of force delivered to the mixing element may be adjusted by the user (being a manual device) and again: there appears to be no reason as to why the manually operated prongs of Bidoia (Bidoia, Fig. 3) for mixing bone cement (Bidoia, “multicomponent bone cement”, Abstract) would not be capable of mixing compositions having cells or cell components especially since bone cements may comprise cell components (Vanderploeg et al., pars. [0002] and [0004]). Thus, the argument is not persuasive.
If Applicant wishes to distinguish their prongs from the prongs of Bidoia, the following limitation (among other options) could be used: “wherein the prongs have a first portion following the contour of the conical bottom and bend to form a second portion following the contour of the cylindrical chamber”.
It is noted that claim 1 would likely be allowable (without further limitations related to the prongs) if amended to clarify the structure of the mixing chamber and extraction funnel, such as by adding “wherein the extraction funnel is disposed opposite to the conical bottom of the mixing chamber when the extraction funnel is attached to the threaded end of the cylindrical chamber” to the end of claim 1.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “the mixing chamber having a conical bottom” in line 12. Since “a conical bottom” is previously recited in the claim, this instance should be changed to “the conical bottom”.
Claim 10 recites “the axis of rotation of the rotatable base” in line 2 and since this axis has not been previously recited, it is recommended to change to “an axis of rotation of the rotatable base”.
Appropriate correction is required.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1 and 7-12 are rejected under 35 U.S.C. 103 as being unpatentable over Sand (US 20020191487) in view of Moreau et al. (previously attached non-patent literature entitled “Self-setting collagen-calcium phosphate bone cement: Mechanical and cellular properties”), Russo (US 9656022), Tunesi (US 20180168930), Finneran (US 20070284330), Barker et al. (US 20040066706), Sarnoff et al. (US 3336924) and Bidoia (US 20060256646).
Regarding claim 1, Sand discloses a method of mixing a composition (such as bone cement, para. [0089]) as shown below:
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Sand discloses the method comprises the steps of: providing a mixing container (receptacle 12) with a main housing (actuator 18 and receptacle 12) with a mixing chamber with an internal mixing blade (mixing element 16) rotatable by a gear mechanism with a plurality of gears (planetary gears 88, Fig. 6a or 6b) in a rotatable base of the mixing container, the main housing having external raised grips (various raised grip configurations shown in Figs. 4a-4f), the mixing container having a quantity of particles inside the mixing chamber (para. [0085], Fig. 10).
Sand does not expressly disclose dry micronized particles.
However, Sand discloses bone cement powder (para. [0003]) and Moreau et al. teaches that bone cement powder may comprise dried micronized particles (Moreau et al., page 2, “Materials and Methods” section, “DCPA powder ground and sieved to obtain particle sizes of 0.4–3 μm” where ground micrometer sized particles reads on “micronized”).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Sand wherein the cement powder comprises micronized particles and the mixing container has a quantity of dried micronized particles inside the mixing chamber.
The person of ordinary skill in the art would have found it obvious to use known types of cement powder in the method, such as powder containing micronized particles.
Sand discloses the mixing chamber has an end attached to an extraction funnel (distal tip 34 and distal end 32 are funnel shaped, Fig. 2a), but Sand does not disclose the extraction funnel has a threaded first end.
However, Russo discloses a method of mixing (fluid is introduced in a chamber and mixed, Abstract) including for mixing powder (as indicated by “crushed pills” in Fig. 4) having a mixing chamber (barrel 18 with chamber 35) having an end attached to an extraction funnel (cap 11), the extraction funnel having a first end with a maximum diameter and narrowing to a minimum diameter at a neck portion at a second end as shown below:
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Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Sand wherein the mixing chamber has an end attached to an extraction funnel, the extraction funnel having a first end with a maximum diameter and narrowing to a minimum diameter at a neck portion at a second end.
The person of ordinary skill in the art would have been motivated to make the extraction funnel separable using threads in order to facilitate cleaning (Russo, col. 8, lines 39-43) and loading of powder material (Russo, Fig. 4). See In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
The above-cited references do not disclose a sealed injection port.
However, Tunesi teaches a method using a mixing chamber (such as formed by containers B1 and B2, Fig. 22) for mixing substances (such as substances S1, S2, or S3, pars. [0028], [0037], [0362]) and further teaches the mixing chamber has an end attached to an extraction funnel (Fig. 22), the extraction funnel having a first end with a maximum diameter (shown below) and narrowing to a minimum diameter at a neck portion at a second end, and the neck portion at the second end having a sealed injection port (para. [0188], injection stopper, Fig. 22) as shown below:
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Further, Finneran teaches a container which is analogous at least because it is reasonably pertinent to the problem of transferring contents from containers using syringes and Finneran teaches a container having an extraction funnel (skirt 60) which is separable from a cylindrical chamber (vial 10) and Finneran further discloses the neck portion at the second end of the funnel has a sealed injection port (perforable liner 34, para. [0055] and [0062], Fig. 7A).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Sand wherein the mixing chamber has an end attached to an extraction funnel, the extraction funnel having a first end with a maximum diameter and narrowing to a minimum diameter at a neck portion at a second end, and the neck portion at the second end having a sealed injection port.
The person of ordinary skill in the art would have found it obvious to utilize a sealed injection port in order to deliver material to the mixing chamber or to fill multiple syringes with needles using the mixing chamber. The person of ordinary skill in the art would have found it obvious to use a funnel on a container with a substance to be used in a syringe in order to avoid wasting the substance (easing the filling of a syringe when very little is left in the container) and to avoid air entrapment in the substance (when filling a syringe when very little of the substance is left in the container).
The combined teachings of the above-cited references disclose wherein the mixing chamber (Sand, receptacle 12, Russo, chamber 35) has a conical bottom (formed by the extraction funnel structure [Russo, cap 11, Tunesi, shown above, Finneran, skirt 60] where the end with the extraction funnel is arbitrarily selected as the “bottom” or otherwise the device may be arranged in space with the funnel pointed toward the ground and thereby comprising a conical bottom of the chamber) and a cylindrical chamber (Sand, shown above, Russo, barrel 18, Finneran, vial 10) with a threaded end (Russo, external screw thread 19) configured to receive the first threaded end of the extraction funnel (Russo, cap 11 with threads 13, Fig. 7).
Sand does not disclose the mixing blade comprises a plurality of prongs extending from a shaft, and wherein the plurality of prongs follow the internal contour of the mixing chamber having a conical bottom.
However, Bidoia teaches a method of mixing a composition (bone cement, Abstract) and Bidoia further teaches the mixing blade comprises a plurality of prongs (blades 57) extending from a shaft (shank 26), wherein the plurality of prongs follow the internal contour of the mixing chamber (receptacle 12) having a conical bottom (the prongs follow the contour in that they are angled in the conical bottom and run parallel to the sidewalls) as shown below:
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Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Sand wherein the mixing blade comprises a plurality of prongs extending from a shaft, and wherein the plurality of prongs follow the internal contour of the mixing chamber having a conical bottom.
The person of ordinary skill in the art would have been motivated to use prongs which extend the entire length of the mixing chamber and follow the contour of the mixing chamber including a conical bottom in order to ensure good mixing throughout the volume of the chamber and to ensure that material doesn’t settle at the bottom of the chamber during mixing.
Insomuch as the above cited references do not explicitly teach injecting a volume of fluid using a needle with a syringe attached through the sealed injection port into the extraction funnel, Barker et al. teaches a method of mixing (mixing bone cement, abstract) and further teaches injecting fluid (such as liquid monomer, para. [0041]) through an injection port (portal 34) using a needle (needle 47) using any suitable container (para. [0043]) or Sarnoff et al. teaches a mixing method using a mixing chamber (vial 132) wherein a liquid is added to the mixing chamber using a syringe (abstract, Figs. 6-7).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Sand wherein the method includes injecting a volume of fluid (such as liquid monomer, Barker et al., para. [0041], Sand, para. [0003]) using a needle with a syringe attached through the sealed injection port into the extraction funnel (Tunesi, shown above, Finneran, skirt 60) and mixing chamber containing the micronized particles.
The person of ordinary skill in the art would have been motivated to transfer liquid through an injection port using a needle in order to mix bone cement (Barker et al., abstract, Sand, para. [0003]) while avoiding contact with liquid (Barker, para. [0009]) and mitigate the risk of injury when handling liquid vials (Barker, para. [0010]).
The method of the combined teachings of the above-cited references further discloses: rotating the base (Sand, para. [0027], Fig. 13) of the mixing container while holding the main housing about the external raised grips (Sand, annotated above and various other raised grips shown in Figs. 4a-4f) to move the plurality of gears (Sand, planetary gears 88, Fig. 6A and 6B) of the gear mechanism to spin the internal mixing blade (Sand, mixing element 16) to incorporate the fluid into the micronized particles to form a wet composition (Sand, para. [0003], page 2, Moreau et al., “Materials and Methods” section, “DCPA powder ground and sieved to obtain particle sizes of 0.4–3 μm”).
Regarding claim 7, the combined teaching of the above-cited references for claim 1 discloses the method comprises the steps of: unthreading the extraction funnel from the main housing; removing the extraction funnel (Russo, unthreaded, Fig. 1) placing the dried micronized particles (Moreau et al., page 2, “Materials and Methods” section, “DCPA powder ground and sieved to obtain particle sizes of 0.4–3 μm”) into the mixing chamber (Russo, Fig. 4, Sand, Fig. 10) and rethreading the extraction funnel onto the main housing (Russo, Fig. 6).
Regarding claim 8, the combined teaching of the above-cited references for claim 1 discloses the mixing chamber has a concave conical bottom (the conical bottom formed by the extraction funnel as discussed for claim 1 above is a concave cone in regard to the inside of the mixing chamber, Sand, distal end 32, Russo, cap 11, Finneran, skirt 60, Tunesi, shown above for claim 1).
Regarding claim 9, Sand further discloses wherein the shaft (axle 87) extends through an opening in the main housing (Fig. 6a and Fig. 11) to inside the rotatable base (actuator 18), an end of the shaft having a gear (sun gear 86, Fig. 6a); and wherein the gear mechanism comprises each of the plurality of gears connected to or intermeshed with an internal gear (ring gear 73) of the rotatable base and the gear of the shaft end (sun gear 86, Fig. 6a).
Regarding claim 10, Sand further discloses wherein the shaft of the mixing blade (axle 87) has an axis of rotation centered and aligned with the axis of rotation of the rotatable base (Fig. 11).
Regarding claim 11, Sand further discloses wherein the rotatable base has the internal gear (ring gear 73) extending circumferentially and is coupled to each of the plurality of gears (planetary gears 88) to form a planetary gear system about the gear of the shaft (sun gear 86) of the mixing blade.
Regarding claim 12, Sand further discloses wherein each of the plurality of gears (planetary gears 88) is larger than the gear of the shaft (sun gear 86, as shown below on the left, Fig. 6A, or as is more apparent from the embodiment shown in Fig. 6B on the right below) and rotation of the rotatable base spins the mixing blade faster than the speed of the rotatable base (para. [0072]).
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Claims 2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Sand (US 20020191487) in view of Moreau et al. (previously attached non-patent literature entitled “Self-setting collagen-calcium phosphate bone cement: Mechanical and cellular properties”), Russo (US 9656022), Tunesi (US 20180168930), Finneran (US 20070284330), Barker et al. (US 20040066706), Sarnoff et al. (US 3336924) and Bidoia (US 20060256646) as applied to claim 1 above and in further view of Rogel Cancer Center (previously attached non-patent literature entitled “Subcutaneous Self-Injection) hereinafter “Rogel”.
Regarding claim 2, the combined teaching of the above cited references for claim 1 disclose inserting a needle with an empty syringe attached into the injection port and extracting the wet composition into the syringe (Tunesi, para. [0188], Sarnoff et al., abstract).
The above-cited references do not disclose inverting the mixing container.
However, Rogel teaches an injection method (title) wherein the container is turned upside down (page 5, step 6).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Sand to further include inverting the mixing container.
The person of ordinary skill in the art would have found it obvious to invert the container in order to assist in avoiding air entry into the syringe.
Regarding claim 5, the combined teachings of the above-cited references for claim 2 disclose injecting or implanting the wet composition in the syringe into a patient (Tunesi, pars. [0189]-[0190], Sarnoff et al., abstract, Sand, para. [0098]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Sand (US 20020191487) in view of Moreau et al. (previously attached non-patent literature entitled “Self-setting collagen-calcium phosphate bone cement: Mechanical and cellular properties”), Russo (US 9656022), Tunesi (US 20180168930), Finneran (US 20070284330), Barker et al. (US 20040066706), Sarnoff et al. (US 3336924) and Bidoia (US 20060256646) as applied to claim 1 above and in further view of Vanderploeg et al. (US 20160184390) and Ying et al. (US 20090169532).
Regarding claim 3, Sand does not teach inserting a needle with a syringe attached into the injection port, the syringe having a quantity of cells or cell components.
However, in the combined teachings of the above cited references for claim 1, components may be added via needle (Barker et al., needle 47 through port 34, Fig. 1) and Moreau et al. who is relied upon to teach micronized particles as discussed for claim 1 above, further teaches the addition of cell components (collagen) after mixing with a liquid (page 3, “specimen fabrication” section) or otherwise Vanderploeg et al. teaches a mixing process for bone cement (para. [0002]) wherein a matrix may include collagen, cells, or cell components (whole blood, platelet-rich plasma, para. [0029]) and Ying teaches a bone cement (Abstract) mixing method wherein cell components may be added (platelets, para. [0060]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Sand wherein the method further comprises the steps of: inserting a needle (Barker et al., needle 47) with a syringe attached into the injection port (Barker, port 34, Tunesi, para. [0188], injection stopper, Fig. 22), the syringe having a quantity of cells or cell components (Moreau et al., collagen, Vanderploeg et al., whole blood, plasma, para. [0029], Ying et al., platelets, para. [0060]); pushing (such as using a syringe with plunger, Sarnoff et al., plunger 104) the cells or cell components into the extraction funnel (Tunesi, shown above for claim 1, Russo, skirt 60) and mixing chamber with the wet composition; and rotating the base (Sand, para. [0027], Fig. 13) of the mixing container to move the plurality of gears of the gear mechanism to spin the internal mixing blade (Sand, element 16) to disperse and incorporate the cells or cell components into the wet composition.
The person of ordinary skill in the art would have been motivated to add cell components in order to assist in osteoblast attachment after injection (Moreau et al., abstract) and facilitate bone growth (Vanderploeg et al., para. [0030]).
Claims 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Sand (US 20020191487) in view of Moreau et al. (previously attached non-patent literature entitled “Self-setting collagen-calcium phosphate bone cement: Mechanical and cellular properties”), Russo (US 9656022), Tunesi (US 20180168930), Finneran (US 20070284330), Barker et al. (US 20040066706) Sarnoff et al. (US 3336924), Bidoia (US 20060256646), Vanderploeg et al. (US 20160184390) and Ying et al. (US 20090169532) as applied to claim 3 above and in further view of Rogel Cancer Center (previously attached non-patent literature entitled “Subcutaneous Self-Injection) hereinafter “Rogel”.
Regarding claim 4, the above cited references for claim 3 disclose inserting a needle with an empty syringe attached into the injection port and extracting the wet composition into the syringe (Tunesi, para. [0188], Sarnoff et al., abstract) wherein the wet composition contains the cell components (collagen, Moreau et al., page 3, “specimen fabrication” section, plasma, Vanderploeg et al., para. [0029], or platelets, Ying et al., para. [0060]).
Sand does not disclose inverting the mixing container.
However, Rogel teaches an injection method (title) wherein the container is turned upside down (page 5, step 6).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Sand to further include inverting the mixing container.
The person of ordinary skill in the art would have found it obvious to invert the container in order to assist in avoiding air entry into the syringe.
Regarding claim 6, the above cited references for claim 4 above disclose injecting or implanting the wet composition with cells or cell components into a patient (the wet composition contains the cell components: collagen, Moreau et al., page 3, “specimen fabrication” section, plasma, Vanderploeg et al., para. [0029], or platelets, Ying et al., para. [0060]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Sand (US 20020191487) in view of Moreau et al. (previously attached non-patent literature entitled “Self-setting collagen-calcium phosphate bone cement: Mechanical and cellular properties”), Russo (US 9656022), Tunesi (US 20180168930), Finneran (US 20070284330), Barker et al. (US 20040066706), Sarnoff et al. (US 3336924) and Bidoia (US 20060256646) as applied to claim 1 above and in further view of Temple (US 20160015754).
Regarding claim 13, Sand does not disclose micronized nucleus pulposus particles.
However, Temple teaches micronized nucleus pulposus particles may be mixed with liquid (rehydrated using various liquids, para. [0023]) and injected using a syringe (para. [0009]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Sand wherein the micronized particles are micronized nucleus pulposus particles.
The person of ordinary skill in the art would have been motivated to use micronized nucleus pulposus particles in order to use the method to repair degenerative discs (Temple, para. [0007]).
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 1 and 7-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7-10 and 19 of copending Application No. No. 19/264386 hereinafter “’386” in view of Sand (US 20020191487).
Regarding claims 1 and 7-13, ‘386 meets the limitations of claims 1 and 7-13 except that ‘386 does not claim a plurality of gears. However, Sand teaches a method of mixing (Abstract) and Sand teaches a mixing blade rotatable by a gear mechanism with a plurality of gears (gears 88, Fig. 6a or 6b). Therefore, it would have been obvious to one of ordinary skill in the art to have modified the claimed invention of ‘386 wherein the mixing container includes a plurality of gears.
This is a provisional nonstatutory double patenting rejection.
Claims 2 and 5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7-10 and 19 of copending Application No. No. 19/264386 hereinafter “’386” in view of Sand (US 20020191487) as applied to claim 1 above and in further view of Rogel Cancer Center (previously attached non-patent literature entitled “Subcutaneous Self-Injection) hereinafter “Rogel”.
Regarding claim 2, ‘386 does not claim inverting the mixing container. However, Rogel teaches an injection method (title) wherein the container is turned upside down (page 5, step 6). Therefore, it would have been obvious to one of ordinary skill in the art to have modified the claimed invention of ‘386 wherein the mixing container is inverted.
Regarding claim 5, ‘386 does not claim injecting or implanting into a patient. However, Sand further teaches implanting in a patient (para. [0098]). Therefore, it would have been obvious to one of ordinary skill in the art to have modified the claimed invention of ‘386 wherein the method includes implanting the wet composition in a patient.
Claims 3-4 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7-10 and 19 of copending Application No. No. 19/264386 hereinafter “’386” in view of Sand (US 20020191487) as applied to claim 1 above and in further view of Rogel Cancer Center (previously attached non-patent literature entitled “Subcutaneous Self-Injection) hereinafter “Rogel”, Vanderploeg et al. (US 20160184390) and Ying et al. (US 20090169532).
Regarding claims 3-4, ‘386 does not claim a syringe having a quantity of cells or cell components or inverting the syringe.
However, Rogel teaches an injection method (title) with a syringe (page 4) wherein the container is turned upside down (page 5, step 6) and Vanderploeg et al. teaches a mixing process for bone cement (para. [0002]) wherein a matrix may include collagen, cells, or cell components (whole blood, platelet-rich plasma, para. [0029]) and Ying teaches a bone cement (Abstract) mixing method wherein cell components may be added (platelets, para. [0060]). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the claimed invention of ‘386 to include a syringe having a quantity of cells or cell components.
Regarding claim 6, ‘386 does not claim injecting or implanting into a patient. However, Sand further teaches implanting in a patient (para. [0098]). Therefore, it would have been obvious to one of ordinary skill in the art to have modified the claimed invention of ‘386 wherein the method includes implanting the wet composition with cells or cell components in a patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK M MCCARTY whose telephone number is (571)272-4398. The examiner can normally be reached Monday - Thursday 9:00 AM - 5:00 PM.
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/P.M.M./Examiner, Art Unit 1774
/CLAIRE X WANG/Supervisory Patent Examiner, Art Unit 1774