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 the Claims
Claims 1-30 are pending and are currently under examination.
Information Disclosure Statement
The IDS dated 11/6/2024 has been considered. A signed copy is enclosed herewith.
Specification
The use of the term Bakelite®, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 5 is objected to because of the following informalities: claim 5 sets out a Markush group of superelastic alloy component alternatives. It is suggested “and” is inserted between the last two alternatives to improve the readability of the claim.
Claim 9 is objected to because of the following informalities: claim 9 sets out a Markush group of outer portion materials. The species “nylon” is recited twice (lines 3 and 5 of the claim). It is suggested that one of the recitations is deleted.
Claim 10 is objected to because of the following informalities: claim 10 recites, “wherein the casing is configured to degrades, dissolves, disassociates, or mechanically weakens...”. It is suggested that the limitation is replaced with “wherein the casing is configured to degrade, dissolve, disassociate, or mechanically weaken...” to improve the readability of the claim.
Claim 15 is objected to because of the following informalities: claim 15 sets out a Markush group of shape memory alloy component alternatives. It is suggested “and” is inserted between the last two alternatives to improve the readability of the claim. It is further suggested that “(X: Zr, B, Cr, Gd)” and “(X= Si, Al, Sn)” use the same formatting for consistency purposes and insert “or” between the last two alternatives, e.g., “(X= Zr, B, Cr, or Gd)” and “(X= Si, Al, or Sn)”.
Claim 24 is objected to because of the following informalities: claim 24 sets out a Markush group of superelastic alloy component alternatives. It is suggested “and” is inserted between the last two alternatives to improve the readability of the claim.
Claim 26 is objected to because of the following informalities: claim 26 sets out a Markush group of shape memory alloy component alternatives. It is suggested “and” is inserted between the last two alternatives to improve the readability of the claim. It is further suggested that “(X: Zr, B, Cr, Gd)” and “(X= Si, Al, Sn)” use the same formatting for consistency purposes and insert “or” between the last two alternatives, e.g., “(X= Zr, B, Cr, or Gd)” and “(X= Si, Al, or Sn)”.
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 9, 19 and 29 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.
Claims 9, 19 and 29 contain the trademark/trade name Bakelite®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a phenol formaldehyde resin and, accordingly, the identification/description is indefinite.
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 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 1-30 are rejected under 35 U.S.C. 103 as being unpatentable over Menachem et al. (US 2015/0342877 A1, Dec. 3, 2015, hereafter as “Menachem”).
The instant claims are drawn to a gastric residence article for oral administration comprising: a foldable central superelastic alloy component; a plurality of elongated limb components loadable with an active substance, the active substance being a therapeutic agent or a diagnostic agent, wherein the plurality of elongated limb components are each connected to the foldable central superelastic alloy component via a linker component, wherein the foldable central superelastic alloy component undergoes elastic deformation when the gastric residence article is in a folded configuration and recoils when the gastric residence article assumes an expanded configuration, and wherein said linker component degrades, dissolves, disassociates, or mechanically weakens, thereby resulting in loss of a shape of the gastric residence article in the expanded configuration.
Regarding instant claims 1 and 5, Menachem teaches a gastric residence article for oral administration (abstract) comprising: a foldable central superelastic alloy component (hinge; see Figs. 3 and 16; shape memory alloy, e.g., Nitinol®, copper-zinc-aluminum-nickel, copper-aluminum-nickel; see [0221], [0243] and [0244]), a plurality of elongated limb components loadable with an active substance, the active substance being a therapeutic agent or a diagnostic agent (arms; see [0075]), wherein the plurality of elongated limb components are each connected to the foldable central superelastic alloy component via a linker component (opposing biasing elements; see [0211] and Fig. 3), wherein the foldable central superelastic alloy component undergoes elastic deformation when the gastric residence article is in a folded configuration and recoils when the gastric residence article assumes an expanded configuration ([0211]), and wherein said linker degrades, dissolves, disassociates, or mechanically weakens, thereby resulting in loss of shape of the gastric residence article in the expanded configuration (erodible biasing element, disassembles; see [0021] and [0224]).
Menachem is silent to a particular embodiment combining each of the elements, 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 combine each of the elements with a reasonable expectation of success because Menachem teaches each of the elements as suitable variations of the device.
Regarding instant claim 2, Menachem is silent to a folding force of at least 0.5 N.
MPEP 2112.01 states,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
As discussed above, Menachem teaches the gastric residence article of claim 1. The prior art product appears to be substantially identical in structure and composition as the claimed product. Accordingly, one of ordinary skill would reasonably expect similar products to possess similar properties. Please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicants’ product differs and, if so, to what extent, from that of the discussed reference. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
Regarding instant claim 3, Menachem teaches that the arms are between 15 and 50 mm (1.5-5.0 cm) and specific embodiment having arms of more than 20 mm (2 cm), more than 25 mm (2.5 cm), etc. ([0223]). In the expanded configuration, the internal angle β can be between about 45 degrees and about 90 degrees or more than 90 degrees ([0210]). Utilizing the 20 mm arm length and the internal angle being about 90 degrees, the opening diameter would be approximately 2.8 cm (i.e., more than 2 cm).
Regarding instant claim 4, Menachem teaches embodiments that the pre-determined period of time that the device will lose its mechanical integrity is more than 24 hours, more than 36 hours, more than 48 hours, 2-180 days, 3-120 days, 3-90 days, etc. ([0017]-[0018] and [0305]).
Regarding instant claim 6, Menachem teaches that the hinge assembly can be coated (securely received within an outer portion) with a pH sensitive erodible material ([0229]). Alternatively, Menachem teaches that the hinge assembly is securely received within other components such as the interior walls (Fig. 3).
Regarding instant claim 7, Menachem is silent to “wherein at least 80% of the folding force is attributed to the foldable central superelastic alloy component”.
MPEP 2112.01 states,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
As discussed above, Menachem teaches the gastric residence article of claims 1 and 6. The prior art product appears to be substantially identical in structure and composition as the claimed product. Accordingly, one of ordinary skill would reasonably expect similar products to possess similar properties. Please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicants’ product differs and, if so, to what extent, from that of the discussed reference. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
Regarding instant claim 8, Menachem teaches that the hinge assembly including the opposing biasing elements (linker component) can be coated with a pH-sensitive material ([0229]; Fig. 4). Menachem also teaches that the opposing biasing elements are coupled to the interior walls (Fig. 3).
Regarding instant claim 9, Menachem teaches suitable pH-sensitive materials include polyacrylic acid derivatives such as acrylic acid and acrylic ester copolymers, methacrylic acid and esters thereof ([0109] and [0230]). Menachem also teaches that body components such as the interior walls can be formed of pH-sensitive materials including polyacrylic acid derivatives such as acrylic acid and acrylic ester copolymers, methacrylic acid and esters thereof ([0109], [0230] and [0335]).
Regarding instant claim 10, Menachem teaches that the collapsed device is encapsulated within a dissolvable capsule and once swallowed, the gastric fluids of the stomach dissolve the capsule and the device expands to its expanded state ([0043], [0225] and[0226]).
Regarding instant claim 11, Menachem teaches the elements of claim 1. Menachem further teaches that the shape memory alloy undergoes a transition from a martensite state to an austenite state ([0244]).
Regarding instant claim 12, Menachem is silent to a folding force of at least 0.5 N.
MPEP 2112.01 states,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
As discussed above, Menachem teaches the gastric residence article of claim 11. The prior art product appears to be substantially identical in structure and composition as the claimed product. Accordingly, one of ordinary skill would reasonably expect similar products to possess similar properties. Please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicants’ product differs and, if so, to what extent, from that of the discussed reference. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
Regarding instant claim 13, Menachem teaches that the arms are between 15 and 50 mm (1.5-5.0 cm) and specific embodiment having arms of more than 20 mm (2 cm), more than 25 mm (2.5 cm), etc. ([0223]). In the expanded configuration, the internal angle β can be between about 45 degrees and about 90 degrees or more than 90 degrees ([0210]). Utilizing the 20 mm arm length and the internal angle being about 90 degrees, the opening diameter would be approximately 2.8 cm (i.e., more than 2 cm).
Regarding instant claim 14, Menachem teaches embodiments that the pre-determined period of time that the device will lose its mechanical integrity is more than 24 hours, more than 36 hours, more than 48 hours, 2-180 days, 3-120 days, 3-90 days, etc. ([0017]-[0018] and [0305]).
Regarding instant claim 15, Menachem teaches the elements above including shape memory alloys, e.g., Nitinol® (Ni-Ti), copper-zinc-aluminum-nickel, copper-aluminum-nickel; see [0221], [0243] and [0244]).
Regarding instant claim 16, Menachem teaches that the hinge assembly can be coated (securely received within an outer portion) with a pH sensitive erodible material ([0229]). Alternatively, Menachem teaches that the hinge assembly is securely received within other components such as the interior walls (Fig. 3).
Regarding instant claim 17, Menachem is silent to “wherein at least 80% of the folding force is attributed to the foldable central superelastic alloy component”.
MPEP 2112.01 states,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
As discussed above, Menachem teaches the gastric residence article of claims 11 and 16. The prior art product appears to be substantially identical in structure and composition as the claimed product. Accordingly, one of ordinary skill would reasonably expect similar products to possess similar properties. Please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicants’ product differs and, if so, to what extent, from that of the discussed reference. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
Regarding instant claim 18, Menachem teaches that the hinge assembly including the opposing biasing elements (linker component) can be coated with a pH-sensitive material ([0229]; Fig. 4). Menachem also teaches that the opposing biasing elements are coupled to the interior walls (Fig. 3).
Regarding instant claim 19, Menachem teaches suitable pH-sensitive materials include polyacrylic acid derivatives such as acrylic acid and acrylic ester copolymers, methacrylic acid and esters thereof ([0109] and [0230]). Menachem also teaches that body components such as the interior walls can be formed of pH-sensitive materials including polyacrylic acid derivatives such as acrylic acid and acrylic ester copolymers, methacrylic acid and esters thereof ([0109], [0230] and [0335]).
Regarding instant claim 20, Menachem teaches a gastric residence article for oral administration (abstract) comprising: a foldable central component comprising a plurality of ribs, wherein the ribs comprise at least one superelastic alloy (hinge assembly having opposing biasing elements; see Figs. 3, 4 and 16; shape memory alloy, e.g., Nitinol®, copper-zinc-aluminum-nickel, copper-aluminum-nickel; see [0211], [0221], [0243] and [0244]), a plurality of elongated limb components radially attached to the foldable central component, the plurality of elongate limb components corresponding to the plurality of ribs (arms; see Fig. 3 and [0217]), and a plurality of linkers components, each of the linker components connecting one of the elongated limb components to the foldable central component (mechanical component such as interior walls or inserts or a chemical component such as an adhesive; see Fig. 3 and [0212]), wherein the ribs are releasable from a folded first state to an unfolded second state for deploying the elongated limb components (the opposing biasing elements transition from a folded state to an unfolded state as the arms also unfold; see Figs. 18 and 19), wherein at least one of the elongated limb components is configured to releasably store drugs ([0075]), and wherein the linker components (inserts) are configured to transform from a rigid first state (engaged) to a disengaged second state to allow the elongated limb component to move independently with respect to the foldable central component (insert erodes and arms disengage from hinge; see [0227]).
Menachem is silent to a particular embodiment combining each of the elements, 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 combine each of the elements with a reasonable expectation of success because Menachem teaches each of the elements as suitable variations of the device.
Regarding instant claim 21, Menachem also teaches that as the insert erodes, the angle β between opposing arms lessens (bends; see [0023] and Fig. 3).
Regarding instant claim 22, Menachem teaches that as the insert erodes, the mechanical integrity of the device decreases and the arms disengage from the hinge assembly ([0227]).
Regarding instant claim 23, Menachem teaches that the linker components (interior walls) comprise a material that undergoes hydrolysis (e.g., cellulose acetate phthalate, acid phthalates of carbohydrates, formalized gelatin, etc.) to transform the linker components from the rigid first state to the disengaged second state ([0109], [0230] and [0335]).
Regarding instant claims 24-26, Menachem teaches the elements above including shape memory alloys, e.g., Nitinol® (Ni-Ti), copper-zinc-aluminum-nickel, copper-aluminum-nickel; see [0221], [0243] and [0244]).
Regarding instant claim 27, Menachem teaches that the hinge assembly including the opposing biasing elements (ribs) can be coated with a pH-sensitive material ([0229]; Fig. 4).
Regarding instant claim 28, Menachem teaches that the linker components (interior walls) connect each of the elongated limb components (arms) to the outer portion (coating) ([0229]; Figs. 2 and 3).
Regarding instant claim 29, Menachem teaches that the outer portion (coating) is a pH-sensitive materials such as polyacrylic acid derivatives such as acrylic acid and acrylic ester copolymers, methacrylic acid and esters thereof ([0109] and [0230]).
Regarding instant claim 30, Menachem teaches that the collapsed device (ribs and arms folded) is encapsulated within a dissolvable capsule and once swallowed, the gastric fluids of the stomach dissolve the capsule and the device (including ribs and arms) expands to its expanded state ([0043], [0225] and[0226]).
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 1-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-29 of copending Application No. 19/191568 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the instant claims and the subject matter of the copending claims are significantly overlapping.
The instant claims are drawn to a gastric residence article for oral administration comprising: a foldable central superelastic alloy component; a plurality of elongated limb components loadable with an active substance, the active substance being a therapeutic agent or a diagnostic agent, wherein the plurality of elongated limb components are each connected to the foldable central superelastic alloy component via a linker component, wherein the foldable central superelastic alloy component undergoes elastic deformation when the gastric residence article is in a folded configuration and recoils when the gastric residence article assumes an expanded configuration, and wherein said linker component degrades, dissolves, disassociates, or mechanically weakens, thereby resulting in loss of a shape of the gastric residence article in the expanded configuration.
The copending claims are drawn to a gastric residence article for oral administration comprising: a foldable central component; a plurality of elongated limb components loadable with an active substance, the active substance being a therapeutic agent or a diagnostic agent, wherein the plurality of elongated limb components are each connected to the foldable central component via a linker component, wherein the foldable central component undergoes elastic deformation when the gastric residence article is in a folded configuration and recoils when the gastric residence article assumes an expanded configuration; and wherein said linker component degrades, dissolves, disassociates, or mechanically weakens, thereby resulting in loss of a shape of the gastric residence article in the expanded configuration. The copending claims further recite, “wherein the gastric residence article is configured to have an opening diameter of at least 2 cm in the expanded configuration”, “the foldable central component is made of a foldable central superelastic alloy component”, “wherein the foldable central superelastic alloy component comprises at least one selected from a group consisting of Nitinol (Ni-Ti), Brass (Cu - Zn), copper-aluminium-nickel (Cu - Al - Ni) alloy, gold-cadmium (Au - Cd) alloy, gold-copper-zine (Au-Cu-Zn) alloy, indium - thallium (In - TI) alloy, cobalt-nickel- aluminium (Co-Ni-Al) alloy, cobalt-nickel-gallium (Co-Ni-Ga) alloy, copper-aluminium- beryllium-zirconium (Cu-Al-Be-Zr), copper-aluminium-beryllium-chromium (Cu-Al-Be-Cr) alloy, copper-aluminium-beryllium-gadolinium (Cu-Al-Be-Gd) alloy, copper-aluminium- nickel-hafnium (Cu-Al-Ni-Hf) alloy, copper-tin (Cu-Sn) alloy, copper-zinc-silicon (Cu-Zn-Si) alloy, copper-zinc-aluminium (Cu-Zn-Al) alloy, copper-zinc-silicon (Cu-Zn-Sn) alloy, iron- manganese-silicon (Fe-Mn-Si) alloy, iron-platinum (Fe-Pt) alloy, manganese-copper (Mn-Cu) alloy, nickel-iron-gallium (Ni-Fe-Ga) alloy, (Ni-Ti-Hf) alloy, nickel-titanium-palladium (Ni- Ti-Pd) alloy, nickel-manganese-gallium (Ni-Mn-Ga) alloy, nickel-manganese-gallium-copper (Ni-Mn-Ga-Cu) alloy, nickel-manganese-gallium-cobalt (Ni-Mn-Ga-Co) alloy, titanium- niobium (Ti-Nb) alloy”, “wherein the foldable central component is made of a foldable central shape memory alloy component”, “wherein the foldable central shape memory alloy component comprises at least one selected from a group consisting of Ni-Ti, Ni- Ti-Hf, Ni-Ti-Pd, Ni-Fe-Ga, Ni-Mn-Ga, Ni-Mn-Ga-Cu, Ni-Mn-Ga-Co, Ag-Cd, Co-Ni-Al, Co- Ni-Ga, Cu-AI-Be-X(X:Zr, B, Cr, Gd), Cu-Al-Ni, Cu-Al-Ni-Hf, Cu-Sn, Cu-Zn, Cu-Zn-X (X = Si, Al, Sn), Fe-Mn-Si, Fe-Pt, Mn-Cu, Ti-Nb”, “wherein the expanded configuration of the gastric residence article has a folding force of at least 0.5 N”, “wherein at least 80% of the folding force is attributed to the foldable central superelastic alloy component”, etc.
Thus, the subject matter of the copending claims anticipates the subject matter of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY HAGOPIAN whose telephone number is (571)272-6097. The examiner can normally be reached on M-F 9:00 am - 5:00 pm.
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/CASEY S HAGOPIAN/Examiner, Art Unit 1617
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