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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-15 in the reply filed on 05/26/2026 is acknowledged.
Claims 16-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/26/2026.
Claims 1-15 are under current examination.
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 3-5 and 9-15 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 3 recites the limitation "at least one intercomponent anchor" in line 2. There is insufficient antecedent basis for this limitation in the claim. Amending the claim to introduce the intercomponent anchor and its structural relationship with the components of the system would obviate the rejection.
The antecedent basis of phrase “a laser linker component” in claim 4, line 1 is unclear because the term does not clearly refer back to the “at least one laser linker component laser welded to the at least one drug eluting component” of claim 1. As such it is unclear whether the claim further limits the laser linker of claim 1 or refers to a separate laser linker, newly introduced. Clarification is required.
The structure of the device claimed in claim 5 is unclear because the retention member of claim 1 contains both a drug eluting component and a laser linker. Claim 5 also requires a laser linker overmolded with the elastomeric component, possibly requiring a minimum of two laser linkers; however, the number of required laser linkers is not clear from the claim.
Claim 9 recites "...a difference between a melt flow index of the at least one laser linker component and a melt flow index of the at least one drug eluting component...". This language renders the claim indefinite because it suggests that there could be greater than one difference between the melt flow indices and more than one melt flow index for a specific substance. However, the specification indicates that the melt flow index is an inherent property of any substance (or mixture of substances). Amending the claim to recite the definite article “the” in place of each instance of the indefinite article “a” in the bolded sections noted above would obviate the rejection. This will not raise concerns over antecedent basis because melt flow indices are inherent properties and therefore necessarily present.
Claim 10 recites "...a difference between a melt flow index of the at least one laser linker component and a melt flow index of the at least one drug eluting component...". This language renders the claim indefinite because it suggests that there could be greater than one difference between the melt flow indices and more than one melt flow index for a specific substance. However, the specification indicates that the melt flow index is an inherent property of any substance (or mixture of substances). Amending the claim to recite the definite article “the” in place of each instance of the indefinite article “a” in the bolded sections noted above would obviate the rejection. This will not raise concerns over antecedent basis because melt flow indices are inherent properties and therefore necessarily present.
Claim 11 recites the limitation "a polycaprolactone content" in line 1. There is insufficient antecedent basis for this limitation in the claim. Amending the claim to introduce the polycaprolactone as present in the component prior to limiting its percentage would obviate the rejection.
Claim 12 recites the limitation "a polycaprolactone content" in line 1. There is insufficient antecedent basis for this limitation in the claim. Amending the claim to introduce the polycaprolactone as present in the component prior to limiting its percentage would obviate the rejection.
Claim 13 recites "...a melting temperature..." in both line 1 and line 2. In each instance, this language renders the claim indefinite because it suggests that there could be greater than one melting temperature for a specific substance. However, the melting temperature is an inherent property of any substance or mixture of substances. Amending the claim to recite the definite article “the” in place of each instance of the indefinite article “a” in both of the bolded sections noted above would obviate the rejection. This will not raise concerns over antecedent basis because melting temperatures are inherent properties and therefore necessarily present.
Claim 14 recites "...a width of a melt zone..." in line 1. This language renders the claim indefinite because it suggests that there could be greater than one width of a given melt zone. Amending the claim to recite the definite article “the” in place of each instance of the indefinite article “a” in the bolded section noted above would obviate the rejection. This will not raise concerns over antecedent basis because a melt zone is an inherent property of something that has been laser welded and therefore necessarily present. The examiner also recommends amending the claim to formally and expressly introduce the presence of a melt zone in the claim before limiting its properties.
Claim 15 recites "...a depth of a melt zone..." in line 1. This language renders the claim indefinite because it suggests that there could be greater than one depth of a given melt zone. Amending the claim to recite the definite article “the” in place of each instance of the indefinite article “a” in the bolded section noted above would obviate the rejection. This will not raise concerns over antecedent basis because a melt zone is an inherent property of something that has been laser welded and therefore necessarily present. The examiner also recommends amending the claim to formally and expressly introduce the presence of a melt zone in the claims before limiting its properties.
Claim Rejections - 35 USC § 102
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 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, 2, and 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kanasty et al. (WO2021092491; published 05/14/2021).
With regard to claims 1 and 2, Kanasty discloses a gastric residence system for administration of active agents such as drugs (title, abstract). The drugs or therapeutic agents elute from gastric residence systems in general (0004) and from Kanasty’s invention the drugs elute from segments referred to as “drug-eluting segments”. These correspond to the “at least one drug eluting component” of instant claim 1. The drug eluting segments are attached to a central elastomer. See Fig 7A: Multiple arms (only one such arm, 108, is labeled for clarity), are affixed to disk-shaped central elastomer 106 (0148).
With regard to claims 1 and 2, the arms formed from the segments and linkers and attached to the central elastomer are considered “retention members” as claimed in the instant application: II) use of arms with controlled stiffness; III) use of timed linkers and enteric linkers which permit higher precision in retention and passage of the gastric residence system (0007). As noted above, these are attached to the central elastomer.
With regard to claim 1, the linkers are welded by IR or laser: FIG. 43 shows an exemplary method of bonding components together to form a gastric residence system. A pre-cut polymeric linker (such as an enteric linker or a time- dependent linker) is laser or IR welded to an elastomeric central member (0369). The examiner notes that the instant specification defines “laser linker components” as follows: “Linker components may be referred to as “laser linker components” when the linker components are attached to drug eluting components using the laser welding techniques described herein.” As such the phrase “laser linker component laser welded to the at least one drug eluting component” represents product by process language. According to MPEP 2113: product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. “The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art”.
The process of laser welding is described in the instant specification to impart the following characteristics:
As described above, the gastric residence systems described herein may be assembled using laser welding techniques. For instance, individual components of a retention member (e.g., one or more drug eluting components and/or laser linker components) may be laser welded together to form a retention member. Laser welding may also be used to attach retention members to an elastomeric component to form a larger gastric residence system (e.g., a stellate system). Using laser welding to join components of a gastric residence system may offer several improvements over conventional techniques. For example, laser welding may create strong bonds between components even if the components have different compositions, properties, and/or functions, while conventional techniques may require components to comprise similar polymers in order to adhere effectively. Laser welding also does not introduce any additional components into a gastric residence system, which minimizes the number of failure points in a gastric residence system and avoids introducing components which are incompatible with human consumption. Furthermore, laser welding may be applied in a manner that prevents damage to heat-sensitive components, such as drug eluting components containing active pharmaceutical ingredients.
The examiner considers the disclosure of Kanasty to anticipate instant claim 1 because the product formed by Kanasty’s method of either IR welding or laser welding appears to be identical to that claimed in the instant application.
With regard to claims 6 and 7, Example 4 is described as: each arm comprises two different inactive segments 1430 and 1440. A first inactive segment 1430 comprises about 39.9 wt% of Corbion PC17, about 59.5 wt% of TPU (PY-PT72AE), about 0.5 wt% of colloidal silicon dioxide and about 0.1 wt% of El 72. A second inactive segment 1440 located at the tip of each arm comprises about 30 wt% of Corbion PC17, about 64.9 wt% of HPMCAS-MG, about 2.5 wt% of stearic acid 50, about 2.5 wt% of prop. Glycol, about 0.025 wt% of E172, and about 0.075 wt% of a pigment. The pigment comprises about 14-16% of FD&C Red 40 A1 Lake (0554). Thus, example 4 contains a central elastomer linked to an inert segment and a enteric disintegrating matrix, the HPMCAS (i.e. hypromellose acetate succinate, see 0480 for definition of PDL).
With regard to claims 6 and 8, the device has inactive segments (0093). Example 1 is described as follows: [0512] The first drug-eluting segment comprises about 45.0 wt% of memantine HC1, about 41.9 wt% of Corbion PC17, about 10.0 wt% of PDL 20, about 2.0 wt% of P407, about 0.5 wt% of Vitamin E succinate, about 0.5 wt% of S1O2, and about 0.1 wt% of Sunset yellow. The second drug-eluting segment comprises about 40.0 wt% of donepezil HC1, about 44.0 wt% of Corbion PC 17, about 10.0 wt% of PDL 20, about 5.0 wt% of P407, about 0.5 wt% of Vitamin E succinate, and about 0.5 wt% of SiCE. Moreover, the first and second drug-eluting segments are separated from the rest of the drug arms by an inactive segment 1140, comprising about 66.495 wt% of Corbion PC17, about 32.0 wt% of VA 64, about 1.5 wt% of P407 and about 0.005 wt% of E172 (0512). Thus, example 1 contains a central elastomer linked to an inert segment and a time-dependent disintegrating matrix, the PDL (i.e. poly-D,L-lactide, see claim 1 for definition of PDL).
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 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Bellinger et al. (US20190262265; published 08/29/2019; cited in the IDS filed 05/26/2026) in view of Kanasty et al. (WO2021092491; published 05/14/2021).
With regard to claim 1, Bellinger discloses a gastric residence system (title, abstract) as depicted in fig 2, drawing sheet 2:
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The system depicted in fig 2 is described as follows in para 0169: An example of a stellate system 200 is shown schematically in FIG. 2. Multiple “arms” (only one such arm, 208, is labeled for clarity) are affixed to asterisk-shaped (disk-shaped) central elastomer 206. The arms depicted in FIG. 2 are comprised of segments 202 and 203, joined by a coupling polymer 204. This configuration permits the system to be folded or compacted in the manner shown for the system 290 in FIG. 2C. Only two arms are shown in FIG. 2C for clarity, and only one arm (298) is labeled for clarity. The central elastomer 296 is folded, such that the overall length of the system is reduced by approximately a factor of two, and the system can be conveniently placed in a container such as a capsule or other container suitable for oral administration.
When expanded, as depicted in fig 2 (left image), the size of device due to the expanded arms prevents entry into the pyloric sphincter and passage into the intestine. Thus, as a consequence of the arms, the system is retained in the stomach and the arms (208) attached to the central elastomer are therefore “retention members”, although Bellinger does not use this term per se. The arms noted in fig 2 are also called elongate members and the elongate members comprise carrier polymer agent components ((0062 - 0063) that contain the therapeutic agent substance to be eluted from the gastric residence system in the gastric environment (0217). Thus, Bellinger discloses a gastric residence system comprising one or more retention members comprising at least one drug eluting component attached to a central elastomer.
The carrier polymer-agent segments (i.e. drug eluting components) are joined together by linkers: In some embodiments of the method, the method further comprises attaching a plurality of carrier polymer-agent components to the plurality of linkers, wherein each one of the carrier polymer-agent components can be attached to a corresponding one of the linkers, to form the gastric residence system (0039). Thus, Bellinger discloses a gastric residence system comprising one or more retention members comprising at least one drug eluting component attached to a central elastomer, wherein the drug eluting segments are linked to other segments by linkers.
Inter alia, Bellinger teaches that in any embodiment of the method described herein, the attaching of a first component to a second component can be performed by infrared welding (0044). However, Bellinger does not disclose laser welded “laser linker components”. The examiner notes that the instant specification defines “laser linker components” as follows: “Linker components may be referred to as “laser linker components” when the linker components are attached to drug eluting components using the laser welding techniques described herein.” As such the phrase “laser linker component laser welded to the at least one drug eluting component” represents product by process language. According to MPEP 2113: product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. “The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art”.
The process of laser welding is described in the instant specification to impart the following characteristics:
As described above, the gastric residence systems described herein may be assembled using laser welding techniques. For instance, individual components of a retention member (e.g., one or more drug eluting components and/or laser linker components) may be laser welded together to form a retention member. Laser welding may also be used to attach retention members to an elastomeric component to form a larger gastric residence system (e.g., a stellate system). Using laser welding to join components of a gastric residence system may offer several improvements over conventional techniques. For example, laser welding may create strong bonds between components even if the components have different compositions, properties, and/or functions, while conventional techniques may require components to comprise similar polymers in order to adhere effectively. Laser welding also does not introduce any additional components into a gastric residence system, which minimizes the number of failure points in a gastric residence system and avoids introducing components which are incompatible with human consumption. Furthermore, laser welding may be applied in a manner that prevents damage to heat-sensitive components, such as drug eluting components containing active pharmaceutical ingredients.
Kanasty, in the analogous art of multicomponent stellate gastroretentive drug delivery systems, discloses that laser welding is an alternative to infrared welding (0369).
It would have been prima facie obvious to laser weld the components of the gastric residence system disclosed by Bellinger because this method was disclosed as a comparably suitable method to the infrared welding taught by Bellinger (see MPEP 2143(D)).
With regard to claim 2, as noted above, Bellinger’s system contains an elastomeric central core that the retention members are connected to.
With regard to claims 3-5, Bellinger teaches overmolding the various components of the system over intercomponent anchors and this applies to any element of the system including elastomeric core, the linkers, or the other segments of the arms (0295).
With regard to claim 6, the instant specification indicates that inactive substances include radiopaque substances, and Bellinger discloses including radiopaque substances in the arms (0279).
With regard to claim 7, the linker can comprise HPMCAS, which is an enteric substance (see Bellinger claim 5).
With regard to claim 8, the linker can comprise PCL, which is a time-dependent disintegrating matrix (see Bellinger claim 5).
With regard to claims 9-10, Bellinger describes optimizing the melt flow indices of the various materials (0074 - 0075 and also the flow at welding temperature: 0374; see also 0607 for description of melt flow index).
With regard to claim 11, Bellinger teaches that any of the embodiments of the gastric residence systems described herein, the linkers can comprise hydroxypropyl methyl cellulose acetate succinate (HPMCAS) and polycaprolactone (PCL); that is, the linkers can be enteric linkers. The ratio of HPMCAS to polycaprolactone can be between about 80% HPMCAS:20% PCL to about 20% HPMCAS:80% PCL. These ranges in PCL overlap with the ranges required by the instant claims, see MPEP 2144.05.
With regard to claim 12, Bellinger discloses that carrier polymer [in the drug eluting segment, see description above] can comprise polycaprolactone (0054).
With regard to claim 13, Kanasty describes optimizing the welding temperature of the materials that need to be welded together by processes that rely on heat (0365). This would reflect the melting temperature of the polymers.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Bellinger et al. (US20190262265; published 08/29/2019; cited in the IDS filed 05/26/2026) in view of Kanasty et al. (WO2021092491; published 05/14/2021) as applied to claims 1-13 above and further in view of Juhl et al. (Polymers 54 (2013) 3891-3897).
The relevant disclosures of Bellinger and Kanasty are set forth above. Neither reference discusses the melt zone width or the depth of the melt zone relative to the depth of the interface between the two laser welded components.
Juhl teaches that:
Polymer laser welding has drawn a lot of attention over the last decade due to its relatively low cost, high quality, and flexibility towards mass customization [16]. The specific process of interest is the TTLW process, where the basic idea is that a laser transparent (not optical transparent) polymer is placed on top of a laser absorbing polymer. The incident laser beam heats up and melts the absorbing polymer, which wets, heats up, and melts the transparent polymer. When both polymers are molten and wetting has occurred, the polymers will inter-diffuse and entangle. The latter requires that the polymers are weld compatible.
One having ordinary skill in the art, e.g. an individual with a Ph.D. in biomedical engineering, would have understood in view of the foregoing that the extent to which the polymers intermingle upon liquifying due to heat imparted by the laser (i.e. the width of the melt zone) and the extent of interface that the melt zone covers would impact the strength of the connection. For this reason, the examiner does not consider the limitations on melt zone width or percentage of the melt zone depth that extends into the interface between components to patentably define over the cited prior art. Optimizing these two parameters to achieve a desired joint strength would have been a matter of routine testing for one of ordinary skill following e.g. the type of guidance provided by Juhl. See MPEP 2144.05.
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, 2, and 6-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-42 of U.S. Patent No. 10182985;
claims 1-13 of U.S. Patent No. 10532027;
claims 1-113 of U.S. Patent No. 10610482;
claims 1-74 of U.S. Patent No. 10517819;
claims 1-69 of U.S. Patent No. 10517820;
claims 1-45 of U.S. Patent No. 10596110;
claims 1-22 of U.S. Patent No. 10716752;
claims 1-40 of U.S. Patent No. 10716751;
claims 1-63 of U.S. Patent No. 11246829;
claims 1-47 of U.S. Patent No. 11077056;
claims 1-45 of U.S. Patent No. 11389399;
claims 1-42 of U.S. Patent No. 11357723;
claims 1-22 of U.S. Patent No. 11576859;
claims 1-22 of U.S. Patent No. 11576866;
claims 1-20 of U.S. Patent No. 11992552;
claims 1-57 of U.S. Patent No. 12023406;
and
claims 1-42 of U.S. Patent No. 12109305
in view of Kanasty et al. (WO2021092491; published 05/14/2021).
Inter alia, the claims of the cited patents embrace a gastric residence system having a central elastomer to which multiple arms/elongate members that may elute drug are attached in a stellate pattern. The stellate shape of the system when the arms are expanded retains the system in the stomach, therefore these arms/elongate members are “retention members” as recited in the instant claims. The components are joined together.
None of the cited patents claim components that have been joined together by “laser linker components laser welded to the at least one drug eluting component”, as required by instant claim 1. The examiner notes that the instant specification defines “laser linker components” as follows: “Linker components may be referred to as “laser linker components” when the linker components are attached to drug eluting components using the laser welding techniques described herein.” As such the phrase “laser linker component laser welded to the at least one drug eluting component” represents product by process language. According to MPEP 2113: product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. “The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art”.
The process of laser welding is described in the instant specification to impart the following characteristics:
As described above, the gastric residence systems described herein may be assembled using laser welding techniques. For instance, individual components of a retention member (e.g., one or more drug eluting components and/or laser linker components) may be laser welded together to form a retention member. Laser welding may also be used to attach retention members to an elastomeric component to form a larger gastric residence system (e.g., a stellate system). Using laser welding to join components of a gastric residence system may offer several improvements over conventional techniques. For example, laser welding may create strong bonds between components even if the components have different compositions, properties, and/or functions, while conventional techniques may require components to comprise similar polymers in order to adhere effectively. Laser welding also does not introduce any additional components into a gastric residence system, which minimizes the number of failure points in a gastric residence system and avoids introducing components which are incompatible with human consumption. Furthermore, laser welding may be applied in a manner that prevents damage to heat-sensitive components, such as drug eluting components containing active pharmaceutical ingredients.
Kanasty, in the analogous art of multicomponent stellate gastroretentive drug delivery systems, discloses that laser welding is an alternative to infrared welding (0369).
It would have been prima facie obvious to laser weld the components of the gastric residence system embraced by the cited patents because this method was disclosed as a suitable method to bind elements together in a nearly identical gastric residence system (see MPEP 2143(D)).
Claims 3-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-42 of U.S. Patent No. 10182985;
claims 1-13 of U.S. Patent No. 10532027;
claims 1-113 of U.S. Patent No. 10610482;
claims 1-74 of U.S. Patent No. 10517819;
claims 1-69 of U.S. Patent No. 10517820;
claims 1-45 of U.S. Patent No. 10596110;
claims 1-22 of U.S. Patent No. 10716752;
claims 1-40 of U.S. Patent No. 10716751;
claims 1-63 of U.S. Patent No. 11246829;
claims 1-47 of U.S. Patent No. 11077056;
claims 1-45 of U.S. Patent No. 11389399;
claims 1-42 of U.S. Patent No. 11357723;
claims 1-22 of U.S. Patent No. 11576859;
claims 1-22 of U.S. Patent No. 11576866;
claims 1-57 of U.S. Patent No. 12023406;
and
claims 1-42 of U.S. Patent No. 12109305
in view of Kanasty et al. (WO2021092491; published 05/14/2021) as applied to claims 1, 2, and 6-13 above, and further in view of Bellinger et al; (US20190262265; published 08/29/2019; cited in the IDS filed 05/26/2026).
The relevant limitations of the cited patents and disclosure of Kanasty are set forth above. None disclose elastomeric component or laser linker overmolded onto an intercomponent anchor.
Bellinger teaches overmolding the various components of the system over intercomponent anchors and this applies to any element of the system including elastomeric core, the linkers, or the other segments of the arms (0295).
It would have been prima facie obvious to overmold to anchors between the components of the gastric residence system embraced by the cited patents because this method was disclosed as a suitable method to bind elements together in a nearly identical gastric residence system (see MPEP 2143(D)).
Claims 14 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-42 of U.S. Patent No. 10182985;
claims 1-13 of U.S. Patent No. 10532027;
claims 1-113 of U.S. Patent No. 10610482;
claims 1-74 of U.S. Patent No. 10517819;
claims 1-69 of U.S. Patent No. 10517820;
claims 1-45 of U.S. Patent No. 10596110;
claims 1-22 of U.S. Patent No. 10716752;
claims 1-40 of U.S. Patent No. 10716751;
claims 1-63 of U.S. Patent No. 11246829;
claims 1-47 of U.S. Patent No. 11077056;
claims 1-45 of U.S. Patent No. 11389399;
claims 1-42 of U.S. Patent No. 11357723;
claims 1-22 of U.S. Patent No. 11576859;
claims 1-22 of U.S. Patent No. 11576866;
claims 1-57 of U.S. Patent No. 12023406;
and
claims 1-42 of U.S. Patent No. 12109305
in view of Kanasty et al. (WO2021092491; published 05/14/2021) as applied to claims 1, 2, and 6-13 above, and further in view of Juhl et al. (Polymers 54 (2013) 3891-3897).
The relevant limitations of the cited patents and disclosure of Kanasty are set forth above. None disclose the melt zone width or the depth of the melt zone relative to the depth of the interface between the two laser welded components.
Juhl teaches that:
Polymer laser welding has drawn a lot of attention over the last decade due to its relatively low cost, high quality, and flexibility towards mass customization [16]. The specific process of interest is the TTLW process, where the basic idea is that a laser transparent (not optical transparent) polymer is placed on top of a laser absorbing polymer. The incident laser beam heats up and melts the absorbing polymer, which wets, heats up, and melts the transparent polymer. When both polymers are molten and wetting has occurred, the polymers will inter-diffuse and entangle. The latter requires that the polymers are weld compatible.
One having ordinary skill in the art, e.g. an individual with a Ph.D. in biomedical engineering, would have understood in view of the foregoing that the extent to which the polymers intermingle upon liquifying due to heat imparted by the laser (i.e. the width of the melt zone) and the extent of interface that the melt zone covers would impact the strength of the connection. For this reason, the examiner does not consider the limitations on melt zone width or percentage of the melt zone depth that extends into the interface between components to patentably define over the cited issued patents and prior art. Optimizing these two parameters to achieve a desired joint strength would have been a matter of routine testing for one of ordinary skill following e.g. the type of guidance provided by Juhl. See MPEP 2144.05.
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-45 of U.S. Patent No. 11992552 (cited in the IDS filed 08/05/2024) in view of in view of Kanasty et al. (WO2021092491; published 05/14/2021).
Inter alia, the claims of the cited patent embrace a gastric residence system having a central elastomer to which multiple arms/elongate members that may elute drug are attached in a stellate pattern. The stellate shape of the system when the arms are expanded retains the system in the stomach, therefore these arms/elongate members are “retention members” as recited in the instant claims. The components are joined together.
The cited patent does not claim components that have been joined together by “laser linker components laser welded to the at least one drug eluting component”, as required by instant claim 1. The examiner notes that the instant specification defines “laser linker components” as follows: “Linker components may be referred to as “laser linker components” when the linker components are attached to drug eluting components using the laser welding techniques described herein.” As such the phrase “laser linker component laser welded to the at least one drug eluting component” represents product by process language. According to MPEP 2113: product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. “The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art”.
The process of laser welding is described in the instant specification to impart the following characteristics:
As described above, the gastric residence systems described herein may be assembled using laser welding techniques. For instance, individual components of a retention member (e.g., one or more drug eluting components and/or laser linker components) may be laser welded together to form a retention member. Laser welding may also be used to attach retention members to an elastomeric component to form a larger gastric residence system (e.g., a stellate system). Using laser welding to join components of a gastric residence system may offer several improvements over conventional techniques. For example, laser welding may create strong bonds between components even if the components have different compositions, properties, and/or functions, while conventional techniques may require components to comprise similar polymers in order to adhere effectively. Laser welding also does not introduce any additional components into a gastric residence system, which minimizes the number of failure points in a gastric residence system and avoids introducing components which are incompatible with human consumption. Furthermore, laser welding may be applied in a manner that prevents damage to heat-sensitive components, such as drug eluting components containing active pharmaceutical ingredients.
Kanasty, in the analogous art of multicomponent stellate gastroretentive drug delivery systems, discloses that laser welding is an alternative to infrared welding (0369).
It would have been prima facie obvious to laser weld the components of the gastric residence system embraced by the cited patents because this method was disclosed as a suitable method to bind elements together in a nearly identical gastric residence system (see MPEP 2143(D)).
Claims 14 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-45 of U.S. Patent No. 11992552 in view of in view of Kanasty et al. (WO2021092491; published 05/14/2021) as applied to claims 1-13 above, and further in view of Juhl et al. (Polymers 54 (2013) 3891-3897).
The relevant limitations of the cited patent and disclosure of Kanasty are set forth above. None disclose the melt zone width or the depth of the melt zone relative to the depth of the interface between the two laser welded components.
Juhl teaches that:
Polymer laser welding has drawn a lot of attention over the last decade due to its relatively low cost, high quality, and flexibility towards mass customization [16]. The specific process of interest is the TTLW process, where the basic idea is that a laser transparent (not optical transparent) polymer is placed on top of a laser absorbing polymer. The incident laser beam heats up and melts the absorbing polymer, which wets, heats up, and melts the transparent polymer. When both polymers are molten and wetting has occurred, the polymers will inter-diffuse and entangle. The latter requires that the polymers are weld compatible.
One having ordinary skill in the art, e.g. an individual with a Ph.D. in biomedical engineering, would have understood in view of the foregoing that the extent to which the polymers intermingle upon liquifying due to heat imparted by the laser (i.e. the width of the melt zone) and the extent of interface that the melt zone covers would impact the strength of the connection. For this reason, the examiner does not consider the limitations on melt zone width or percentage of the melt zone depth that extends into the interface between components to patentably define over the cited issued patents and prior art. Optimizing these two parameters to achieve a desired joint strength would have been a matter of routine testing for one of ordinary skill following e.g. the type of guidance provided by Juhl. See MPEP 2144.05.
Claims 1, 2, and 6-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1, 2, 5, 7, 8, 10, 11, 13, 14, 17, 20, 22-24, 29, 31-33, 35, and 70 of copending Application No. 17774126
claims 1, 4, 14, 3, 34, ,41,52, 57, 65, 68, 72, 75, 87, 116, 137-139, 142, and 145 of copending Application No. 17774127
claims 1, 6, 26, 27, 60, 61, 82, 86, 87, 89, 155-160, 162, 163, and 169 of copending Application No. 17774128;
claims 1-3, 25, 40, 60, 127-129, 131, 132, 135, 136, 143-147, 218, and 224 of copending Application No. 17774132;
claims 80-86 and 88-105 of copending Application No. 17836972;
claims 1, 10, 31, 33-35, 37, 38, 40, 41, 46, 51, 52, 55, 57, 82, and 90 of copending Application No. 18272786;
claims 1, 5-19, 36, 40, 41, 63, 64, 68-74, 97, 101, and 102 of copending Application No. 18289331;
claims 1, 2, 10, 31, 33-35, 37, 38, 40, 41, 46-48, 51, 52, 55, 57, 70, 80, and 93 of copending Application No. 18729705;
claims 1-25 of copending Application No. 18825519;
claims 1-20 of copending Application No. 19068466; and
claims 1-104 of copending Application No. 19732053
in view of Kanasty et al. (WO2021092491; published 05/14/2021).
Inter alia, the claims of the cited applications embrace a gastric residence system having a central elastomer to which multiple arms/elongate members that may elute drug are attached in a stellate pattern. The stellate shape of the system when the arms are expanded retains the system in the stomach, therefore these arms/elongate members are “retention members” as recited in the instant claims. The components are joined together.
None of the cited applications claim components that have been joined together by “laser linker components laser welded to the at least one drug eluting component”, as required by instant claim 1. The examiner notes that the instant specification defines “laser linker components” as follows: “Linker components may be referred to as “laser linker components” when the linker components are attached to drug eluting components using the laser welding techniques described herein.” As such the phrase “laser linker component laser welded to the at least one drug eluting component” represents product by process language. According to MPEP 2113: product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. “The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art”.
The process of laser welding is described in the instant specification to impart the following characteristics:
As described above, the gastric residence systems described herein may be assembled using laser welding techniques. For instance, individual components of a retention member (e.g., one or more drug eluting components and/or laser linker components) may be laser welded together to form a retention member. Laser welding may also be used to attach retention members to an elastomeric component to form a larger gastric residence system (e.g., a stellate system). Using laser welding to join components of a gastric residence system may offer several improvements over conventional techniques. For example, laser welding may create strong bonds between components even if the components have different compositions, properties, and/or functions, while conventional techniques may require components to comprise similar polymers in order to adhere effectively. Laser welding also does not introduce any additional components into a gastric residence system, which minimizes the number of failure points in a gastric residence system and avoids introducing components which are incompatible with human consumption. Furthermore, laser welding may be applied in a manner that prevents damage to heat-sensitive components, such as drug eluting components containing active pharmaceutical ingredients.
Kanasty, in the analogous art of multicomponent stellate gastroretentive drug delivery systems, discloses that laser welding is an alternative to infrared welding (0369).
It would have been prima facie obvious to laser weld the components of the gastric residence system embraced by the cited applications because this method was disclosed as a suitable method to bind elements together in a nearly identical gastric residence system (see MPEP 2143(D)).
This is a provisional nonstatutory double patenting rejection.
Claims 3-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1, 2, 5, 7, 8, 10, 11, 13, 14, 17, 20, 22-24, 29, 31-33, 35, and 70 of copending Application No. 17774126
claims 1, 4, 14, 3, 34, ,41,52, 57, 65, 68, 72, 75, 87, 116, 137-139, 142, and 145 of copending Application No. 17774127
claims 1, 6, 26, 27, 60, 61, 82, 86, 87, 89, 155-160, 162, 163, and 169 of copending Application No. 17774128;
claims 1-3, 25, 40, 60, 127-129, 131, 132, 135, 136, 143-147, 218, and 224 of copending Application No. 17774132;
claims 80-86 and 88-105 of copending Application No. 17836972;
claims 1, 10, 31, 33-35, 37, 38, 40, 41, 46, 51, 52, 55, 57, 82, and 90 of copending Application No. 18272786;
claims 1, 5-19, 36, 40, 41, 63, 64, 68-74, 97, 101, and 102 of copending Application No. 18289331;
claims 1, 2, 10, 31, 33-35, 37, 38, 40, 41, 46-48, 51, 52, 55, 57, 70, 80, and 93 of copending Application No. 18729705;
claims 1-25 of copending Application No. 18825519;
claims 1-20 of copending Application No. 19068466; and
claims 1-104 of copending Application No. 19732053
in view of Kanasty et al. (WO2021092491; published 05/14/2021) as applied to claims 1, 2, and 6-13 above, and further in view of Bellinger et al; (US20190262265; published 08/29/2019; cited in the IDS filed 05/26/2026).
The relevant limitations of the cited applications and disclosure of Kanasty are set forth above. None disclose elastomeric component or laser linker overmolded onto an intercomponent anchor.
Bellinger teaches overmolding the various components of the system over intercomponent anchors and this applies to any element of the system including elastomeric core, the linkers, or the other segments of the arms (0295).
It would have been prima facie obvious to overmold to anchors between the components of the gastric residence system embraced by the cited applications because this method was disclosed as a suitable method to bind elements together in a nearly identical gastric residence system (see MPEP 2143(D)).
This is a provisional nonstatutory double patenting rejection.
Claims 14 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1, 2, 5, 7, 8, 10, 11, 13, 14, 17, 20, 22-24, 29, 31-33, 35, and 70 of copending Application No. 17774126
claims 1, 4, 14, 3, 34, ,41,52, 57, 65, 68, 72, 75, 87, 116, 137-139, 142, and 145 of copending Application No. 17774127
claims 1, 6, 26, 27, 60, 61, 82, 86, 87, 89, 155-160, 162, 163, and 169 of copending Application No. 17774128;
claims 1-3, 25, 40, 60, 127-129, 131, 132, 135, 136, 143-147, 218, and 224 of copending Application No. 17774132;
claims 80-86 and 88-105 of copending Application No. 17836972;
claims 1, 10, 31, 33-35, 37, 38, 40, 41, 46, 51, 52, 55, 57, 82, and 90 of copending Application No. 18272786;
claims 1, 5-19, 36, 40, 41, 63, 64, 68-74, 97, 101, and 102 of copending Application No. 18289331;
claims 1, 2, 10, 31, 33-35, 37, 38, 40, 41, 46-48, 51, 52, 55, 57, 70, 80, and 93 of copending Application No. 18729705;
claims 1-25 of copending Application No. 18825519;
claims 1-20 of copending Application No. 19068466; and
claims 1-104 of copending Application No. 19732053
in view of Kanasty et al. (WO2021092491; published 05/14/2021) as applied to claims 1, 2, and 6-13 above, and further in view of Juhl et al. (Polymers 54 (2013) 3891-3897).
The relevant limitations of the cited applications and disclosure of Kanasty are set forth above. None disclose the melt zone width or the depth of the melt zone relative to the depth of the interface between the two laser welded components.
Juhl teaches that:
Polymer laser welding has drawn a lot of attention over the last decade due to its relatively low cost, high quality, and flexibility towards mass customization [16]. The specific process of interest is the TTLW process, where the basic idea is that a laser transparent (not optical transparent) polymer is placed on top of a laser absorbing polymer. The incident laser beam heats up and melts the absorbing polymer, which wets, heats up, and melts the transparent polymer. When both polymers are molten and wetting has occurred, the polymers will inter-diffuse and entangle. The latter requires that the polymers are weld compatible.
One having ordinary skill in the art, e.g. an individual with a Ph.D. in biomedical engineering, would have understood in view of the foregoing that the extent to which the polymers intermingle upon liquifying due to heat imparted by the laser (i.e. the width of the melt zone) and the extent of interface that the melt zone covers would impact the strength of the connection. For this reason, the examiner does not consider the limitations on melt zone width or percentage of the melt zone depth that extends into the interface between components to patentably define over the cited issued patents and prior art. Optimizing these two parameters to achieve a desired joint strength would have been a matter of routine testing for one of ordinary skill following e.g. the type of guidance provided by Juhl. See MPEP 2144.05.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 2, and 6-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 and 25-30 of copending Application No. 19082659 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims.
Inter alia, the claims of the cited applications embrace a gastric residence system having a central elastomer to which multiple arms/elongate members that may elute drug are attached in a stellate pattern. The stellate shape of the system when the arms are expanded retains the system in the stomach, therefore these arms/elongate members are “retention members” as recited in the instant claims. The components are joined together by laser linkers.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 3-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 and 25-30 of copending Application No. 19082659 (reference application) as applied to claims 1, 2, and 6-13 above, and further in view of Bellinger et al; (US20190262265; published 08/29/2019; cited in the IDS filed 05/26/2026).
The relevant limitations of the cited are set forth above. None disclose elastomeric component or laser linker overmolded onto an intercomponent anchor.
Bellinger teaches overmolding the various components of the system over intercomponent anchors and this applies to any element of the system including elastomeric core, the linkers, or the other segments of the arms (0295).
It would have been prima facie obvious to overmold to anchors between the components of the gastric residence system embraced by the cited application because this method was disclosed as a suitable method to bind elements together in a nearly identical gastric residence system (see MPEP 2143(D)).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 14 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 and 25-30 of copending Application No. 19082659 (reference application) as applied to claims 1, 2, and 6-13 above, and further in view of Juhl et al. (Polymers 54 (2013) 3891-3897).
The relevant limitations of the cited application are set forth above. None disclose the melt zone width or the depth of the melt zone relative to the depth of the interface between the two laser welded components.
Juhl teaches that:
Polymer laser welding has drawn a lot of attention over the last decade due to its relatively low cost, high quality, and flexibility towards mass customization [16]. The specific process of interest is the TTLW process, where the basic idea is that a laser transparent (not optical transparent) polymer is placed on top of a laser absorbing polymer. The incident laser beam heats up and melts the absorbing polymer, which wets, heats up, and melts the transparent polymer. When both polymers are molten and wetting has occurred, the polymers will inter-diffuse and entangle. The latter requires that the polymers are weld compatible.
One having ordinary skill in the art, e.g. an individual with a Ph.D. in biomedical engineering, would have understood in view of the foregoing that the extent to which the polymers intermingle upon liquifying due to heat imparted by the laser (i.e. the width of the melt zone) and the extent of interface that the melt zone covers would impact the strength of the connection. For this reason, the examiner does not consider the limitations on melt zone width or percentage of the melt zone depth that extends into the interface between components to patentably define over the cited issued patents and prior art. Optimizing these two parameters to achieve a desired joint strength would have been a matter of routine testing for one of ordinary skill following e.g. the type of guidance provided by Juhl. See MPEP 2144.05.
This is a provisional nonstatutory double patenting rejection.
Claims 1-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 43-45, 47-55, 57, 60-63, 65, 68, and 69 of copending Application No. 18637281 in view of Kanasty et al. (WO2021092491; published 05/14/2021).
Inter alia, the claims of the cited application embrace a gastric residence system having a central elastomer to which multiple arms/elongate members that may elute drug are attached in a stellate pattern. The stellate shape of the system when the arms are expanded retains the system in the stomach, therefore these arms/elongate members are “retention members” as recited in the instant claims. The components are joined together.
The cited application does not claim components that have been joined together by “laser linker components laser welded to the at least one drug eluting component”, as required by instant claim 1. The examiner notes that the instant specification defines “laser linker components” as follows: “Linker components may be referred to as “laser linker components” when the linker components are attached to drug eluting components using the laser welding techniques described herein.” As such the phrase “laser linker component laser welded to the at least one drug eluting component” represents product by process language. According to MPEP 2113: product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. “The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art”.
The process of laser welding is described in the instant specification to impart the following characteristics:
As described above, the gastric residence systems described herein may be assembled using laser welding techniques. For instance, individual components of a retention member (e.g., one or more drug eluting components and/or laser linker components) may be laser welded together to form a retention member. Laser welding may also be used to attach retention members to an elastomeric component to form a larger gastric residence system (e.g., a stellate system). Using laser welding to join components of a gastric residence system may offer several improvements over conventional techniques. For example, laser welding may create strong bonds between components even if the components have different compositions, properties, and/or functions, while conventional techniques may require components to comprise similar polymers in order to adhere effectively. Laser welding also does not introduce any additional components into a gastric residence system, which minimizes the number of failure points in a gastric residence system and avoids introducing components which are incompatible with human consumption. Furthermore, laser welding may be applied in a manner that prevents damage to heat-sensitive components, such as drug eluting components containing active pharmaceutical ingredients.
Kanasty, in the analogous art of multicomponent stellate gastroretentive drug delivery systems, discloses that laser welding is an alternative to infrared welding (0369).
It would have been prima facie obvious to laser weld the components of the gastric residence system embraced by the cited application because this method was disclosed as a suitable method to bind elements together in a nearly identical gastric residence system (see MPEP 2143(D)).
This is a provisional nonstatutory double patenting rejection.
Claims 14 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 43-45, 47-55, 57, 60-63, 65, 68, and 69 of copending Application No. 18637281 in view of Kanasty et al. (WO2021092491; published 05/14/2021) as applied to claims 1-13 and further in view of Juhl et al. (Polymers 54 (2013) 3891-3897).
The relevant limitations of the cited application and disclosure of Kanasty are set forth above. None disclose the melt zone width or the depth of the melt zone relative to the depth of the interface between the two laser welded components.
Juhl teaches that:
Polymer laser welding has drawn a lot of attention over the last decade due to its relatively low cost, high quality, and flexibility towards mass customization [16]. The specific process of interest is the TTLW process, where the basic idea is that a laser transparent (not optical transparent) polymer is placed on top of a laser absorbing polymer. The incident laser beam heats up and melts the absorbing polymer, which wets, heats up, and melts the transparent polymer. When both polymers are molten and wetting has occurred, the polymers will inter-diffuse and entangle. The latter requires that the polymers are weld compatible.
One having ordinary skill in the art, e.g. an individual with a Ph.D. in biomedical engineering, would have understood in view of the foregoing that the extent to which the polymers intermingle upon liquifying due to heat imparted by the laser (i.e. the width of the melt zone) and the extent of interface that the melt zone covers would impact the strength of the connection. For this reason, the examiner does not consider the limitations on melt zone width or percentage of the melt zone depth that extends into the interface between components to patentably define over the cited issued patents and prior art. Optimizing these two parameters to achieve a desired joint strength would have been a matter of routine testing for one of ordinary skill following e.g. the type of guidance provided by Juhl. See MPEP 2144.05.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE PEEBLES/ Primary Examiner, Art Unit 1617
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