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 .
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/553,214, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The limitations, low temperature chamber, high temperature chamber, thermal barrier, the low temperature chamber is maintained from about 4 °C to about 8 °C, bag or other holder for media, including about 1 L or more of fluid, flat and non-flexible cell culture chamber having a chamber height of less than 5.0 cm, pump, the chamber height is about 0.5 cm to about 4.0 cm, the cell culture chamber has a volume of about 0.5 mL to about 300 mL, ports (claim 12), carbon dioxide sensor, silicone tubing component, have no support in Application No. 62/553,214. Similarly, the disclosure of the prior-filed application, Application No. 62/670,391, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The limitations, thermal barrier, bag or other holder for media, including about 1 L or more of fluid, flat and non-flexible cell culture chamber having a chamber height of less than 5.0 cm, the chamber height is about 0.5 cm to about 4.0 cm, the cell culture chamber has a volume of about 0.5 mL to about 300 mL, ports (claim 12), carbon dioxide sensor, silicone tubing component, have no support in Application No. 62/670,391. Therefore, the effective filing date for the current pending claims is August 31, 2018, which is the earliest date sufficient to provide adequate support for the claimed features.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/11/2022; 11/21/2022; 02/23/2023; 04/11/2023; 7/12/2023; 08/06/2024; 6/27/2025; 02/18/2026, have been considered and made of record.
Claim Objections
Claims 8 and 13 are objected to because of the following informalities: In claims 8 and 13, the limitation “wherein the cassette further includes one or more of a pH sensor, a glucose sensor, an oxygen sensor, a carbon dioxide sensor, a lactic acid sensor and/or an optical density sensor,” should read “wherein the cassette further includes one or more of a pH sensor, a glucose sensor, an oxygen sensor, a carbon dioxide sensor, a lactic acid sensor and an optical density sensor.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "wherein the fluidics pathways" in line 10. However, it is unclear which fluidics pathways of the one or more fluidics pathways the limitations is referring to. The rejection can be overcome by amending the claim to recite -- the one or more fluidics pathways --. Claims 2-8 are included in this rejection by virtue of their dependency upon a rejected base claim.
Claim 2 recites the limitation "wherein the low temperature chamber is maintained from about 4 °C to about 8 °C." However, the limitation “about 4 °C to about 8 °C” renders the claim indefinite. The language of the claim is such that one of ordinary skill in the art could not interpret the meets and bounds of the claim. In particular, it is not clear as to what range is covered by said limitation. The rejection can be overcome by deleting the term “about.”
Claim 3 recites the limitation "wherein the high temperature chamber is maintained from about 35 °C to about 40 °C." However, the limitation “about 35 °C to about 40 °C” renders the claim indefinite. The language of the claim is such that one of ordinary skill in the art could not interpret the meets and bounds of the claim. In particular, it is not clear as to what range is covered by said limitation. The rejection can be overcome by deleting the term “about.”
Claim 9 recites the limitation "wherein the fluidics pathways" in line 10. However, it is unclear which fluidics pathways among the one or more fluidics pathways recited earlier in the claim the limitations is referring to. The rejection can be overcome by amending the claim to recite -- the one or more fluidics pathways --. Claims 10-13 are included in this rejection by virtue of their dependency upon a rejected base claim.
Claim 10 recites the limitation "the chamber" in line 1. However, it is unclear which chamber among the low and high temperature chambers as recited earlier in the claim the limitations is referring to.
Claim 10 recites the limitation "wherein the chamber height is about 0.5 cm to about 4.0 cm." However, the limitation “about 0.5 cm to about 4.0 cm” renders the claim indefinite. The language of the claim is such that one of ordinary skill in the art could not interpret the meets and bounds of the claim. In particular, it is not clear as to what range is covered by said limitation. The rejection can be overcome by deleting the term “about.”
Claim 11 recites the limitation "wherein the cell culture chamber has a volume of about 0.5 mL to about 300 mL." However, the limitation “about 0.5 mL to about 300 mL” renders the claim indefinite. The language of the claim is such that one of ordinary skill in the art could not interpret the meets and bounds of the claim. In particular, it is not clear as to what range is covered by said limitation. The rejection can be overcome by deleting the term “about.”
Claim 14 recites the limitation "wherein the fluidics pathways" in line 9. However, it is unclear which fluidics pathways of the one or more fluidics pathways the limitations is referring to. The rejection can be overcome by amending the claim to recite -- the one or more fluidics pathways --. Claims 15-19 are included in this rejection by virtue of their dependency upon a rejected base claim.
Claim 14 recites the limitation "wherein the fluidics pathways" in line 9. However, it is unclear which
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 –
(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.
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith et al. (WO 2005/116186-A1; hereinafter “Smith”).
Regarding claim 1, Smith discloses a cassette for use in an automated cell engineering system (see FIG. 1), the cassette comprising: a low temperature chamber for storage of a cell culture media (FIGS. 3-4 and 9: lower fluid reservoir (300); page 8, third full paragraph; paragraph bridging pages 14 to 15; pages 24 to 25); a high temperature chamber for carrying out activation, transduction and expansion of an immune cell culture (FIGS. 3-4: upper housing (200); page 8, third full paragraph; paragraph bridging pages 14 to 15; pages 24 to 25); and a thermal barrier, wherein the high temperature chamber is separated from the low temperature chamber by the thermal barrier (lower chamber is formed of insulating material; paragraph bridging pages 14 to 15), wherein the high temperature chamber includes a cell culture chamber and one or more fluidics pathways connected to the cell culture chamber (FIGS. 3-4 and 6: chamber assembly (600) coupled to fluidic pathways; page 8, third full paragraph; page 10, second full paragraph; paragraph bridging pages 15 to 16), and wherein the fluidics pathways provide recirculation, removal of waste and homogenous gas exchange and distribution of nutrients to the cell culture chamber without disturbing cells within the cell culture chamber (page 8, third full paragraph; page 20, first full paragraph; fluidics pathways of Smith are structurally the same as the instant fluidics pathways and thus considered to be fully capable “provide recirculation, removal of waste and homogenous gas exchange and distribution of nutrients to the cell culture chamber without disturbing cells within the cell culture chamber.”)
Furthermore, it is noted that the recitations of functional language "e.g., for storage of a cell culture media; for carrying out activation, transduction and expansion of an immune cell culture" are drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed system and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 2, Smith further discloses wherein the low temperature chamber is maintained from about 4 °C to about 8 °C (low temperature chamber is coupled to temperature controller for maintaining the content within the low temperature as desired temperature level; paragraph bridging pages 14 to 15; pages 24-25). Furthermore, the limitation “wherein the low temperature chamber is maintained from about 4 °C to about 8 °C,” is directed to a manner of operating disclosed system, it is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2114 and 2115.
Regarding claim 3, Smith further discloses wherein the high temperature chamber is maintained from about 35 °C to about 40 °C (paragraph bridging pages 14 to 15; pages 24-25). Furthermore, the limitation “wherein the high temperature chamber is maintained from about 35 °C to about 40 °C,” is directed to a manner of operating disclosed system, it is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2114 and 2115.
Regarding claim 4, Smith further discloses wherein the low temperature chamber can further include a bag or other holder for media, including about 1 L or more of fluid (low temperature of Smith can contain the claimed bag or other holder for media having the claimed volume; paragraph bridging pages 14 to 15).
Regarding claim 5, Smith further discloses wherein the cassette further includes one or more pumps for driving fluid through the cassette (pump (224); page 17, second full paragraph; page 20, first full paragraph).
Regarding claim 6, Smith further discloses wherein the cassette further includes one or more valves for controlling the flow through the fluidic pathways (flow control valves (212a-212g, 212r-212v); page 8, third full paragraph; page 17, second full paragraph; page 20, first full paragraph).
Regarding claim 7, Smith further discloses wherein the cassette further includes one or more sampling ports and/or injection ports (page 8, third paragraph).
Therefore, Smith meets and anticipates the limitations set forth in claims 1-7.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Smith as applied to claim 1 above. This is alternative rejection to the rejection of claim 4 above.
Regarding claim 4, Smith discloses the cassette of according to claim 1 as set forth above. Smith further discloses a wherein the low temperature chamber can further include a bag or other holder for media (paragraph bridging pages 14 to 15).
Smith discloses wherein the bag or other holder for media has a volume but does not explicitly disclose wherein the volume is about 1 L or more of fluid. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the volume of the bag or other holder for media of Smith to have any volume including the claimed volume, since such a modification would have involved a mere change in the size (or dimension) of a component. A change in size (dimension) is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04 IV. A.). Further, one of ordinary skill in the art would have made said modification so as to hold 1 L or more of desired media within the cassette.
Regarding claim 8, Smith discloses wherein the cassette further includes at least one sensor or monitoring parameters within the low chamber and high chamber (page 3; claim 69). Smith further disclose wherein gases such oxygen and carbon dioxide are introduced into the cassette so as to maintain said gases as desired level within the high chamber. Although not specifically disclosed by Smith, it would have been intrinsic in the system of Smith to monitor the oxygen and carbon dioxide in the high chamber using a known means (e.g., oxygen and carbon dioxide sensors) in order to ascertain that the necessary oxygen and carbon dioxide levels had been reached.
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (WO 2005/116186-A1).
Regarding claim 9, Smith discloses a cassette for use in an automated cell engineering system (see FIG. 1), the cassette comprising: a low temperature chamber for storage of a cell culture media (FIGS. 3-4 and 9: lower fluid reservoir (300); page 8, third full paragraph; paragraph bridging pages 14 to 15; pages 24 to 25); and a high temperature chamber for carrying out activation, transduction and expansion of an immune cell culture (FIGS. 3-4: upper housing (200); page 8, third full paragraph; paragraph bridging pages 14 to 15; pages 24 to 25), wherein the high temperature chamber includes: a flat cell culture chamber (see FIG. 6 and page 5) having a chamber height (FIG. 6; page 11), and one or more fluidics pathways connected to the cell culture chamber (FIGS. 3-4 and 6: chamber assembly (600) coupled to fluidic pathways; page 8, third full paragraph; page 10, second full paragraph; paragraph bridging pages 15 to 16), wherein the fluidics pathways provide recirculation, removal of waste and homogenous gas exchange and distribution of nutrients to the cell culture chamber without disturbing cells within the cell culture chamber (page 8, third full paragraph; page 20, first full paragraph; fluidics pathways of Smith are structurally the same as the instant fluidics pathways and thus considered to be fully capable “provide recirculation, removal of waste and homogenous gas exchange and distribution of nutrients to the cell culture chamber without disturbing cells within the cell culture chamber.”) Smith does not explicitly disclose wherein the flat cell culture chamber is non-flexible. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the cell culture chamber of Smith with non-flexible material to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill in the art would have made said modification because said modification would have been the substitution of one known material for another. Further, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960) (see MPEP § 2144.07). Smith discloses wherein the cell culture chamber has a height (see page 11; FIG. 6), but does not explicitly disclose wherein the height is less than 5.0 cm. However, Smith does disclose wherein the height of the cell culture chamber can be optimized according to need (page 26). It would therefore have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the height of the cell culture chamber of Smith to any height including the claimed height, since such a modification would have involved a mere change in the size (or dimension) of a component. A change in size (dimension) is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04 IV. A.). Further, one of ordinary skill in the art would have made said modification because Smith discloses that the height of the cell culture chamber can be optimized according to need (page 26).
Furthermore, it is noted that the recitations of functional language "e.g., for storage of a cell culture media; for carrying out activation, transduction and expansion of an immune cell culture" are drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed system and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 10, modified Smith discloses wherein the low temperature chamber has a height (FIGS. 3-4), but does not explicitly disclose wherein the height is about 0.5 cm to about 4.0 cm. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the height of the low temperature chamber of Smith to any height including the claimed height, since such a modification would have involved a mere change in the size (or dimension) of a component. A change in size (dimension) is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04 IV. A.).
Regarding claim 11, modified Smith discloses wherein the cell culture chamber has a volume but does not explicitly disclose wherein the volume is about 0.5 mL to about 300 mL. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the volume of the cell culture chamber of modified Smith to have any volume including the claimed volume, since such a modification would have involved a mere change in the size (or dimension) of a component. A change in size (dimension) is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04 IV. A.). Further, one of ordinary skill in the art would have made said modification so as to process desired volume of materials within the cassette.
Regarding claim 12, modified Smith further discloses wherein the cell culture chamber further comprises at least one of: a distal port configured to allow for the removal of air bubbles from the cell culture chamber and/or as a recirculation port; a medial port configured to function as a recirculation inlet port; and a proximal port configured to function as a drain port for cell removal (Ports (616,618); see FIG. 6; page 11).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Smith as applied to claim 9 above.
Regarding claim 13, modified Smith discloses the cassette of according to claim 9 as set forth above.
Modified Smith discloses wherein the cassette further includes at least one sensor or monitoring parameters within the low chamber and high chamber (page 3; claim 69). Smith further disclose wherein gases such oxygen and carbon dioxide are introduced into the cassette so as to maintain said gases as desired level within the high chamber. Although not specifically disclosed by Smith, it would have been intrinsic in the system of Smith to monitor the oxygen and carbon dioxide in the high chamber using a known means (e.g., oxygen and carbon dioxide sensors) in order to ascertain that the necessary oxygen and carbon dioxide levels had been reached.
Claims 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (WO 2005/116186-A1) in view of Peterson et al. (US 4,530,907; hereinafter “Peterson”).
Regarding claim 14, Smith discloses a cassette for use in an automated cell engineering system (see FIG. 1), the cassette comprising: a low temperature chamber for storage of a cell culture media (FIGS. 3-4 and 9: lower fluid reservoir (300); page 8, third full paragraph; paragraph bridging pages 14 to 15; pages 24 to 25); and a high temperature chamber for carrying out activation, transduction and expansion of an immune cell culture (FIGS. 3-4: upper housing (200); page 8, third full paragraph; paragraph bridging pages 14 to 15; pages 24 to 25), wherein the high temperature chamber includes: a cell culture chamber (upper housing (200) includes a chamber (600); see FIGS. 3-4 and 6; page 5); and one or more fluidics pathways connected to the cell culture chamber (FIGS. 3-4 and 6: chamber assembly (600) coupled to fluidic pathways including gases pathways; page 8, third full paragraph; page 10, second full paragraph; paragraph bridging pages 15 to 16), and wherein the fluidics pathways provide recirculation, removal of waste and homogenous gas exchange and distribution of nutrients to the cell culture chamber without disturbing cells within the cell culture chamber (page 8, third full paragraph; page 20, first full paragraph; fluidics pathways of Smith are structurally the same as the instant fluidics pathways and thus considered to be fully capable “provide recirculation, removal of waste and homogenous gas exchange and distribution of nutrients to the cell culture chamber without disturbing cells within the cell culture chamber.”) Smith does not explicitly disclose wherein the fluidics pathways comprise a silicon-based tubing component that allows oxygenation through the tubing component. However, Smith does disclose wherein the one or more fluidics pathways including gas exchange pathways (page 10). Peterson discloses that a silicone tube can be used for oxygenation (col. 3, ll. 59-60). In view of Peterson, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the oxygenation means of Smith with the oxygenation means of Peterson comprising a silicon-based tubing component to arrive at the claimed invention. Further, one of ordinary skill in the art would have made said modification because said modification would have been the substitution of one known oxygenation means for another for the predictable result of oxygenating fluid in a receptacle. Furthermore, it is noted that the recitations of functional language "e.g., for storage of a cell culture media; for carrying out activation, transduction and expansion of an immune cell culture" are drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed system and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 15, modified Smith further discloses wherein the low temperature chamber can further include a bag or other holder for media, including about 1 L or more of fluid (low temperature of Smith can contain a bag or other holder for media having the claimed volume; paragraph bridging pages 14 to 15).
Regarding claim 16, Smith further discloses wherein the cassette further includes one or more pumps for driving fluid through the cassette (pump (224); page 17, second full paragraph; page 20, first full paragraph).
Regarding claim 17, Smith discloses wherein the cassette further includes one or more valves for controlling the flow through the fluidic pathways (flow control valves (212a-212g, 212r-212v); page 8, third full paragraph; page 17, second full paragraph; page 20, first full paragraph).
Regarding claim 18, Smith further discloses wherein the cassette further includes one or more sampling ports and/or injection ports (page 8, third paragraph).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Smith as applied to claim 14 above.
Regarding claim 19, modified Smith discloses the cassette of according to claim 14 as set forth above. Modified Smith discloses wherein the cassette further includes at least one sensor or monitoring parameters within the low chamber and high chamber (page 3; claim 69). Smith further disclose wherein gases such oxygen and carbon dioxide are introduced into the cassette so as to maintain said gases as desired level within the high chamber. Although not specifically disclosed by Smith, it would have been intrinsic in the system of Smith to monitor the oxygen and carbon dioxide in the high chamber using a known means (e.g., oxygen and carbon dioxide sensors) in order to ascertain that the necessary oxygen and carbon dioxide levels had been reached.
Double Patenting
The no statutory 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-19 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-5 and 8-9 of copending Application No. 18/247,406 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Conclusion
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/LIBAN M HASSAN/Primary Examiner, Art Unit 1799
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