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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/30/2025 has been entered.
Applicants' arguments, filed 09/30/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112 - New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 5-8, 10, 14, and 17, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “wherein a ratio of the at least one active substance and the at least one biodegradable organic polymer is 1:19 or more and 1:1.5 or less.” This limitation does not appear to be supported by the instant specification because there appears to be no mention of active substance to biodegradable organic polymer ratios anywhere in the specification or in the originally filed claims. The only ratios mentioned in the instant specification appear to be the ratio of polymer to lipid. While paragraphs [0086]-[0109] disclosed a range for the percent by weight of the active substance and polymer, no ratios are disclosed. Therefore the limitation appears to be New Matter. Accordingly, claims 3, 5-8, 10, 14, and 17 are also rejected for depending on claim 1.
Claim Rejections - 35 USC § 112(b) or pre-AIA 2nd ¶
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 5-8, 10, 14, and 17, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “wherein a ratio of the at least one active substance and the at least one biodegradable organic polymer is 1:19 or more and 1:1.5 or less.” The range is unclear as 1:19 or more suggests ratios that can be greater than 1:1.5, and 1:1.5 or less appears to suggest ratios that can be less than 1:19. The examiner notes that this limitation also appears to be new matter for the reasons discussed above, however, for purposes of examination, the limitation will be interpreted as “1:19 to 1:1.5.” Claims 3, 5-8, 10, 14, and 17 are also rejected from depending from claim 1.
Claim 8 recites “wherein the extruded depot comprises a homogenous core coating.” This limitation appears to lack antecedent basis where claim 8 depends from claim 1, and there is no recitation of a “core.” For purposes of examination, the claim will be interpreted as a homogenous coating on the extruded depot from of claim 1.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3, 5-7, 14, 17, are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Lyons et al (US 20150141484 A1).
Lyons et al disclose biocompatible implants for administering siRNA, with embodiments comprising 10-20 wt% siRNA, 2-5 wt% of cholesterol or PEG3350, and either single PLGA polymer or double PLGA polymer blends (abs, ex. 4, ¶ 146, claim 1). Particular embodiments, for example, comprise 10 wt% siRNA, 5 wt% PEG, and a polymer component comprised of 100% RG752 (poly(D,L-lactide-co-glycolide) (¶¶ 143, 151). The polymers used in other embodiments of ex. 4 were polymers and blends of polymers selected from poly(D,L-lactide-co-glycolide) polymers and poly(D,L-lactide) polymers (¶ 143, see ex. 4 working embodiments). The blends were hot melt extruded to implants (¶ 147). The implants were cut into 5-6 mm (0.5-0.6 cm) pieces (¶ 149). The polymer component is about 75-85 wt% (claim 1).
Regarding claims 1 and 3, Lyons et al discloses an extruded implant (i.e., extruded depot) comprising 10-20 wt% siRNA (nucleic acid), at least one biodegradable polymer selected from the group consisting of poly(D,L-lactide-co-glycolide) and poly(D,L-lactide) at about 75-85 wt%, wherein the ratio of active agent to biodegradable organic polymer ranges from about 1:8.5 to about 1:3.75 (calculated from the wt% of siRNA and polymer), and wherein the extruded depot has a length of 5-6 mm (0.5-0.6 cm).
While the reference does not disclose Applicants’ elected active substance of mRNA, the examiner notes that the reference will be used to its fullest extent as it applies to the instant claims. Accordingly, and without expanding the species, where Lyons et al discloses embodiments as instantly claimed comprising siRNA, claims 1 and 3 are met.
Regarding claim 5, Lyons et al discloses embodiments as instantly claimed further comprising cholesterol (lipid).
Regarding claim 6, Lyons et al discloses embodiments wherein the at least one active substance, the at least one biodegradable organic polymer, and the at least one lipid comprise at least about 50 wt% of the depot form.
Regarding claims 7 and 17, Lyons et al discloses embodiments as instantly claimed comprising polyethylene glycol, thereby reading on the excipient instantly claimed.
Regarding claim 14, where Lyons et al discloses extruded implants that are capable of being used for intraocular delivery of siRNA, the extruded depot form appears to read on a medical or veterinary composition.
Claim Rejections - 35 USC § 103
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lyons et al (US 20150141484 A1), as applied to claims 1, 3, 5-8, 10, 14, and 17 above, and further in view of Lyons et al (US 20150141484 A1).
Lyons et al is discussed above but does not teach a particular working embodiment disclosing the ratio of diameter to length of instant claim 10.
Lyons et al further teach the implants have lengths, for example, from 1 to 10 mm, and may have a length of 2 mm with a diameter of 0.75 mm, or having a length from about 7 mm to about 10 mm and a diameter of about 0.75 mm to about 1.5 mm (¶ 84).
It would have been obvious to formulate the extruded depot of Lyons et al with a length and diameter taught to be suitable by Lyons et al, such as a length from about 7 mm to about 10 mm and a diameter of about 0.75 mm to about 1.5 mm, resulting in a calculated ratio of length to diameter of about 1:13.33 to about 1:4.67, falling within the claimed range.
Claims 1, 3, 5-8, 10, 14, and 17, are rejected under 35 U.S.C. 103 as being unpatentable over Lyons et al (US 20150141484 A1), in view of Partenhauser (WO 2018172494 A1, cited on IDS dated 03/08/2022).
Lyons et al is discussed above but do not teach wherein the active agent is mRNA, nor does the reference disclose a particular working embodiment disclosing a homogenous core coating of claim 8.
Lyons et al further teach the implant may be coextruded so that a coating is formed over a core region during the manufacture of the implant (¶ 110).
Partenhauser is discussed below.
Regarding the selection of mRNA as the active substance, it would have been obvious to modify the extruded depots of Lyons et al by substituting mRNA for siRNA, as taught by Partenhauser, where both are directed to extruded depot forms for prolonged release of an active substance.
Regarding claim 8, where Lyons et al teach core coating were suitable, it would have been obvious to further include a homogenous core coating comprising at least one active substance and the biodegradable polymer, as taught by Partenhauser, where the homogenous core coatings limit the initial burst release of active ingredient from the depot form and ensures therapeutic concentrations of the at least one active ingredient over a sustained period of time.
Claims 1, 3, 5-8, 10, 14, and 17, stand rejected under 35 U.S.C. 103 as being unpatentable over Canal et al (US 5536508 A), in view of Partenhauser (WO 2018172494 A1, cited on IDS dated 03/08/2022).
Canal et al disclose pharmaceutical compositions in the form of extruded particles for delayed and controlled release of an active (abs, col 3 lines 6-8), comprising: an active agent, co-poly(lactic-glycolic) acid (PLGA, biodegradable polymer), lecithin (lipid), polyethylene glycol (excipient) (ex. 17, 18). The extruded depots may comprise a great deal of different active agents both synthetic and natural, with provided examples being non-limiting (col 4 lines 12-23). The amount of active agents in the particles is comprised between 0.01-99.9 wt%, and preferably between 1-50 wt% (col 4 lines 62-64). In examples, the active substance is included at 77 g, PLGA at 250 g, polyethylene glycol at 250 g, and lecithin at 15 g (ex. 18), resulting in a ratio of active substance to biodegradable polymer of 77:250 (simplified to about 1:3.25). The compositions of the present invention may be employed in manufacturing different pharmaceutical formulations, including implants, oral formulations, etc. (col 5 lines 41-54).
Canal et al do not specifically teach mRNA as an active, that the co-poly(lactic-glycolic) acid is poly(D,L-lactide-co-glycolide) specifically, the homogenous core coating of claim 8, nor the diameter length parameters of claims 9 and 10.
Partenhauser is discussed below.
Regarding the extruded depot form of claim 1, the pharmaceutical composition in the form of extruded particles reads on extruded depot form as instantly claimed, where “depot form” is defined by Applicants in the instant specification at pg. 2 lines 26-28 to mean any medicinal product with the release of active substance occurs in a delayed manner over a long period of time (i.e., delayed controlled release).
Regarding nucleic acids of claims 1 and 3, it would have been obvious to include other active agents known to be suitable for controlled release extruded depots, such as mRNA, as taught by Partenhauser.
Regarding the amount of mRNA of claim 1, it would have been obvious to include mRNA in amounts that were known to be suitable for active agents, such as the preferred range of 1-50 wt%, as taught by Canal et al, overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). Further, the skilled artisan would reasonably be expected to determine the optimal working ranges of mRNA active for desired therapeutic properties.
Regarding the ratio of active substance to biodegradable polymer of claim 1, the newly amended claim limitation appears to be new matter for the reasons discussed above. Nevertheless, it would have been obvious for the skilled artisan to start with known ratios of active agent to biodegradable polymer that are taught to be suitable by Canal et al, such as about 1:3.25, and adjust from there in order to achieve desired optimal therapeutic activity and device properties, where the amount of mRNA made obvious above can vary. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions. See MPEP 2144.05(II)(A).
Regarding the length of claim 1, it would have been obvious to formulate the extruded depot of Canal et al with a length in the range of 0.1-5 cm, as taught by Partenhauser, wehre both are drawn to extruded depot forms for controlled release of an active.
Regarding the biodegradable polymer of claim 1, where Canal et al teaches PLGA as the biodegradable polymer, it would have been obvious to select from known forms of PLGA that are suitable for extruded depot forms for controlled release of an active, including mRNA, such as poly(D,L-lactide-co-glycolide), as taught by Partenhauser.
Regarding claim 5, the depot form made obvious above comprises lecithin, a lipid.
Regarding claim 6, it would have been obvious to formulate the extruded depot made obvious above wherein the active substance, the biodegradable organic polymer, and lipid comprises at least 50 wt% of the depot form, as used in ex. 18 of Canal et al, which appears to make up greater than 50 wt%.
Regarding claims 7 and 17, the depot form made obvious above comprises polyethylene glycol (excipient).
Regarding claim 8, it would have been obvious to further include a homogenous coating comprising at least one active substance and the biodegradable polymer, as taught by Partenhauser, where homogenous core coatings were known to limit the initial burst release of active ingredient from extruded depot forms and ensure therapeutic concentrations of the at least one active ingredient over a sustained period of time, as taught by Partenhauser.
Regarding claim 10, it would have been obvious to formulate the extruded depot of Canal et al with a known diameter to length ratio suitable for biodegradable depot forms for controlled release of an active, such as from about 1:30 to about 10:1, as taught by Partenhauser.
Regarding claim 14, the uses are intended uses as being medical, veterinary or cosmetic composition, and they are satisfied where Canal et al teaches a pharmaceutical composition.
Response to Arguments
First, Applicants assert Canal et al teach particle diameters from 0.1-150 micron, which are smaller than the extruded depot of claim 1, which is from 0.1-5 cm (1,000-50,000 micron). Thus, Applicants assert the structural composition described by Canal et al is not the same as the extruded depot of claim 1. Applicants assert it would not have been obvious to modify Canal et al to arrive at the claimed size of extruded depot, where Canal teaches particles of micron size, wherein Canal et al teach making an extruded product that is then further micronized. Second, Applicants assert the affidavit demonstrates superiority of the biodegradable polymer selected from poly(D,L-lactide-co-glycolide) and poly(D,L-lactide). Applicants assert these organic polymers result in depot forms with superior properties in terms of processing temperatures, degradation, mechanical and dimensional stability after processing, and resistance to non-enzymatic hydrolysis. Applicants assert these properties would not have been expected based on the teachings of Canal et al and Winter et al.
First, respectfully, this argument is not persuasive. While Canal et al teach extruded depots that may have been later processed for desired use, with particle diameters from 0.1-150 microns, the particles are still an extruded depot; and where extruded biodegradable depots are known in the prior art with sizes overlapping or falling within the claimed depot sizes, such as in Partenhauser, it would have been obvious for the skilled artisan to adjust the size of the extruded particles to other known extruded depot sizes known for controlled release of an active, in order to optimize the extruded depot forms for desired uses. Still, where Applicants are arguing the product by process of Canal et al, the instant claims can be read broadly to include an extruded depot comprising the particles of Canal et al. As such, where Canal et al teaches the extruded product may be employed in implants, for example, it would have been obvious to use the particles of Canal et al in the extruded depot forms of Partenhauser.
Second, respectfully, this argument is not persuasive. Applicants assert the claimed polymers are superior to other polymers in terms of processing temperatures, degradation, mechanical and dimensional stability after processing, and resistance to non-enzymatic hydrolysis in their response and in the affidavit dated 09/30/2025, however, Applicants have not provided any evidence to support their assertion of improved properties. On pg. 1 of the affidavit, Applicants assert that other polymers may lead to depot forms with inferior characteristics, which is not objective evidence, but instead is merely attorney argument. Objective evidence must be factually supported by an appropriate affidavit or declaration to be of probative value includes evidence of unexpected results. Arguments presented by the applicant cannot take the place of evidence in the record, including statements regarding unexpected results. See MPEP 716.01(c) and 2145(I). Therefore, Applicants assertion of improved properties, which appear to just be known physical properties of the polymers, and the assertion that other polymers may result in inferior characteristic, constitute mere argument.
Claims 1, 3, 5-8, 10, 14, and 17, are rejected under 35 U.S.C. 103 as being unpatentable over Partenhauser (WO 2018172494 A1, cited on IDS dated 03/08/2022).
Partenhauser teaches extruded depot forms for prolonged active substance release (abs). Example 3 discloses a preparation comprising 10 wt% exenatide (active agent), 20 wt% poly(D,L-lactide-co-glycolide (PLGA), 35 wt% high-melting triglyceride (lipid), and 35 wt% of a low melting hard fat (lipid) (example 3). Other suitable active agents include one or more of mRNA, siRNA, etc. (¶ 46). The melting compounds and adjuvant for modulating active release is about 60 wt% of the dry weight of the depot form (¶ 35). The amount of active substance can vary within a wide range, such as about 0.3 wt% to about 50 wt% (¶ 54). Pore forming agents may be included such as polyethylene glycol, trehalose, dextrins, etc., wherein the pore forming agents can improve the delivery of the active substance and modulates drug release (¶ 55, claim 5). The extruded depot forms have a homogenous core coating having a homogenous composition comprising the active substance, the melting compounds, and/or the at least one adjuvant (i.e., PLGA), which limits the initial burst release of active ingredient from the depot form and ensures therapeutic concentrations of the at least one active ingredient over a sustained period of time (¶¶ 34, 87). The extruded depot forms have an appropriate shape and size with a length in the range of 0.1-5 cm (claim 9). The extruded depot forms have a diameter to length ratio from about 1:30 to about 10:1 (¶ 93, claim 10). The extruded depot forms are related to medical, veterinary, and cosmetic use (¶ 26).
Regarding the active agent of claims 1 and 3, it would have been obvious to substitute mRNA for exenatide, where both are taught as suitable active agents for the extruded depot forms, as taught by Partenhauser.
Regarding the amount of mRNA of claim 1, it would have been obvious to include mRNA, within the ranges taught to be suitable for active agents, such as from about 0.3 to about 50 wt%, as taught by Partenhauser, overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding the biodegradable organic polymer of claim 1, example 3 of Partenhauser comprises poly(D,L-lactide-co-glycolide).
Regarding the ratio of the active substance to the biodegradable organic polymer of claim 1, the newly amended claim limitation appears to be new matter for the reasons discussed above. Nevertheless, where the mRNA made obvious above can vary in the range from 0.3-50 wt%, based on the weight of the extruded depot form, it would have been obvious for the skilled artisan to start with known ratios of active agent to biodegradable polymer that are taught to be suitable by Partenhauser, such as the 1:2 ratio of ex. 3 (10 wt% active substance and 20 wt% PLGA), and adjust from there in order to achieve desired optimal therapeutic activity and properties. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions. See MPEP 2144.05(II)(A).
Regarding the length of claim 1, it would have been obvious to formulate the extruded depot forms with a length in the range of 0.1-5 cm, as taught by Partenhauser.
Regarding claim 5, example 3 of Partenhauser comprises at least one lipid.
Regarding claim 6, the total amount of active substance, biodegradable organic polymer, and lipid in example 3 of Partenhauser is greater than 50 wt% of the dry weight of the depot form.
Regarding claims 7 and 17, it would have been obvious to further include excipients, such as polyethylene glycol, trehalose, dextrins, etc., where these excipients were known to improve the delivery of the active substance and modulates drug release, as taught by Partenhauser.
Regarding claim 8, it would have been obvious to further include a homogenous core coating comprising at least one active substance and the biodegradable polymer, as taught by Partenhauser, where the homogenous core coatings limit the initial burst release of active ingredient from the depot form and ensures therapeutic concentrations of the at least one active ingredient over a sustained period of time, as taught by Partenhauser.
Regarding claim 10, it would have been obvious to formulate the extruded depot forms with a diameter to length ratio from about 1:30 to about 10:1, as taught by Partenhauser.
Regarding claim 14, the intended use limitations of a medical, veterinary or cosmetic composition are met where Partenhauser teaches the extruded depot forms are suitable for medical, veterinary and cosmetic use.
Response to Arguments
Applicants assert Partenhauser teaches poly(D,L-lactide-co-glycolide) from a long list of substances, and Partenhauser does not disclose an extruded depot form wherein the ratio of the active compound to the polymer is at least 1:19 and at most 1:1.5. Applicants assert paragraphs [0062]-[0082] of Partenhauser merely include amounts of individual ingredients, but does not compare these amounts to any other ingredients. As such, Applicants assert there is no indication in these paragraphs that any other ingredients exist in the composition, much less the specific ratio of active substance to the polymer as recited in claim 1.
Respectfully, this argument is not persuasive. While claim 5 of Partenhauser includes poly(D,L-lactide-co-glycolide) in a list, the working embodiment of Partenhauser cited above specifically uses poly(D,L-lactide-co-glycolide) (see ex. 3). Applicants also assert that Partenhauser does not disclose the ratios as instantly claimed, however, this limitation appears to be new matter for the reasons discussed above. Nevertheless, cited ex. 3 comprises 10 wt% active substance and 20 wt% PLGA, which equates to a 1:2 ratio, falling within the range. As such, when formulating the extruded depots comprising mRNA made obvious above, it would have been obvious for the skilled artisan to start with known ratios of active agent to biodegradable polymer that are taught to be suitable by Partenhauser, such as the 1:2 ratio from the working examples of Partenhauser, and adjust from there in order to achieve desired optimal therapeutic activity and device properties. See MPEP 2144.05(II)(A). Further, a skilled artisan would reasonably be expected to determine the optimal working ranges for the ratio of mRNA to polymer for desired therapeutic properties.
Double Patenting
Claims 1, 3, 5-8, 10, 14, and 17, stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 17/753,588 (reference application), hereinafter referred to as ‘588, in view of Partenhauser (WO 2018172494 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘588 disclose an extruded depot form comprising at least one active substance at 20-50 wt%; at least one biodegradable organic polymer selected from poly(D,L-lactide-co-glycolide) and poly(D,L-lactide); and at least one lipid, wherein the at least one biodegradable organic polymer and the at least one lipid preferable comprise at least 50% by weight of the dry weight of the depot form (claim 1). The extruded depot further comprises one or more excipients selected from the group consisting of an enzyme, polyethylene oxide, etc. (all of the same excipients of instant claim 7) (claim 6). The active substance is selected from mRNA, etc. (claim 8). The depot form comprises a homogeneous core coating comprising the at least one active substance and the at least one biodegradable organic polymer, and the at least one lipid (claim 9). The extruded depot has a length of 0.1 cm to 5 cm (claim 10), with a ratio of diameter to length of 1:30 to 10:1 (claim 11). A medical, veterinary or cosmetic composition comprising the extruded depot (claim 15). The one or more excipients is selected from the group consisting of a lipase, polyethylene glycol, calcium chloride, trehalose, a cyclodextrin, and cellulose (claim 17).
The claims of ‘588 do not specifically disclose the ratio of active substance to biodegradable organic polymer of instant claim 1.
Partenhauser is discussed above.
Regarding the ratio, the newly amended claim limitation appears to be new matter for the reasons discussed above. Nevertheless, it would have been obvious to include mRNA and organic polymer in ratios that were known to be suitable for active agents in extruded depot forms, such as 1:2, as taught by Partenhauser, and adjust from there in order to achieve desired therapeutic activity, for the same reasons discussed above and of record. Further, a skilled artisan would reasonably be expected to determine the optimal working ranges for the ratio of mRNA to polymer for desired therapeutic properties.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants assert that as claim 1 has been amended to include limitations not recited in ‘588, the double patenting rejection is now moot.
Respectfully, this argument is not persuasive. The double patenting rejection over the claims of ‘588 has been modified to make obvious Applicants’ newly added amendments to instant claim 1. Accordingly, the claims stand rejected for the same reasons above and of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/MARIANNE C SEIDEL/Primary Examiner, Art Unit 1600