DETAILED ACTION
Status of the Claims
Claims 12-31 are pending in the instant application. Claim 18 has been withdrawn based upon Restriction/Election as discussed below. Claims 12-17 and 19-31 are being examined on the merits in the instant application.
Advisory Notice
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Restriction/Election
Applicant's election with traverse of Group I drawn to compositions of matter, currently claims 12-17 and 19-31 in the reply filed on 06/15/2023 is acknowledged. The traversal is “on the ground(s) that on the grounds that consideration of the full scope of the claims would pose no undue burden, as searching for the compositions of Group I will necessarily also search for methods of use of those compositions.” This is not found persuasive because searching the full scope would pose a search burden as evidenced by (a) the inventions have acquired a separate status in the art in view of their different classification; (b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or (c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries).
The requirement is still deemed proper and is therefore made FINAL.
Claim 18 has been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/15/2023.
Priority
The instant Application is a continuation of 17/048,773 filed 10/19/2020 (USPN 11,690,799), 17/048,773 is a 371 of PCT/EP2019/060396 filed 04/23/2019, and claims priority to GERMANY 10 2018 109 460.4 filed 04/19/2018 and GERMANY 10 2018 114 930.1 filed 06/21/2018.
The U.S. effective filing date has been determined to be 04/23/2019, the filing date of PCT/EP2019/060396. Applicant's claim for a priority dates of, 04/19/2018 and 06/21/2018, the filing date of document the above GERMAN Applications, is acknowledged, however no English translation of the foreign priority documents has/have been provided such that the examiner can confirm 112(a) support therein. Accordingly, foreign priority to GERMANY 10 2018 109 460.4 filed 04/19/2018 and/or GERMANY 10 2018 114 930.1 filed 06/21/2018 cannot be afforded at this time.
Information Disclosure Statement
The information disclosure statements submitted on 06/23/2023, 01/23/2024 and 06/06/2024 were filed before the mailing date of the first office action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: “adjuvants and additives” [emphasis added]. The examiner finds no disclosure of additives in the as-filed Specification.
Claim Rejections - 35 USC § 112(b)
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 12-17 and 19-31 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 pre-AIA the applicant regards as the invention.
Claim 12 is rejected as being indefinite because the claim recites “a completely soluble formulation” in lines 1-2 where it is unclear what exactly the solution the formulation should be completely soluble in, or if Applicant means completely soluble in the skin of the user. Appropriate clarification is required. Claims 13-17 and 19-31 inherit this limitation and are also unclear for the same reasoning.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 12-13, 16-17, 19, 21, 23 and 29 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Chen et al.1 (Dissolving microneedle-based intradermal delivery of interferon-α-2b”, 2015, Taylor & Francis; Drug Development and Industrial Pharmacy, Vol. 42, No. 6, pp. 890-896).
Applicant Claims
A microneedle array, comprising interferon and a completely soluble formulation including polyvinylpyrrolidone for use in the intradermal delivery of interferon, wherein polyvinylpyrrolidone is the major constituent of the formulation (instant claim 1).
Disclosure of the Prior Art
Chen et al. discloses a dissolving microneedle-based intradermal delivery of interferon-α-2b (title, see whole document). Chen et al. discloses that: “The PDMS mold was placed into a beaker of water containing 0.1% (w/v) tween 80 and treated by ultrasonic for 30 s to drive the air bubbles out of the MNs cavities of the mold. After that, clean up the water on the surface of the mold. Then, the two-solution system was utilized. In brief, 20 ml of the solution one containing 1% (w/v) Fluorescein sodium as the model drug and 5% (w/v) CS as the tip matrix was added onto the surface of the mold, and the drug and matrix would enter the MNs cavities of the mold as the water evaporates. Then, the solution two of 45% (w/v) PVP was added onto the surface of the mold, and dried under room temperature. Finally, MNs was peeled out of the mold and take pictures using a camera (Ricoh CaplioR7). Figure 2 illustrates the process of fabrication.” [emphasis added](p. 891, §Production of dissolving MNs). And further that: “The solution one was prepared by mixing 1ml IFN solution (1.05 mg/ml) and 0.05 g CS. According to the method mentioned above, 10, 20, 30 and 40 ml of the solution one were added to prepare IFN MNs with various doses, and then the solution two of 45% (w/v) PVP was added.” (p. 891, §Fabrication of IFN MNs)(instant claim 12, interferon and polyvinylpyrrolidone which is the major constituent; instant claim 19, “and further adjuvants and additives” which includes polysorbate (i.e. Tween 80), and Chondroitin sulfate (CS), instant claim 21 amount of polysorbate, and instant claim 29 a solvent which is water).
Chen et al. discloses that: “The experiments were divided into four groups: one group for intramuscular injection (IM), others for MNs with low (2.43±0.32 mg, MNsL), middle (5.50±1.06 mg, MNsM) and high (11.70±1.22 mg, MNsH) dose.” (p. 892, col. 2, lines 1-5)(instant claim 13).
Chen et al. discloses that “Then IFN MNs was put onto the surface of porcine skin and applied by an applicator for 150 s.” (p. 892, col. 1, §In vitro release and safety studies of IFN MNs; and p. 894, Figure 5A)(instant claims 16-17, for use in intradermal delivery of interferon, instant claim 23 “an applicator).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 12-17, 19-22 and 25-29 are rejected under 35 U.S.C. 103 as being unpatentable over MOORE (US 2014/0188041 A1; published July, 2014) in view of DEKKER (US 2005/0181033 A1; published August, 2005) and Dillon et al. (“Formulation and characterisation of dissolving microneedles for the transdermal delivery of therapeutic peptides,” 2017, ELSEVIER; International Journal of Pharmaceutics, Vol. 526, pp. 125-136).
Applicants Claims
Applicant claims a microneedle array, comprising interferon and a completely soluble formulation including polyvinylpyrrolidone for use in the intradermal delivery of interferon, wherein polyvinylpyrrolidone is the major constituent of the formulation (instant claim 1).
Determination of the scope
and content of the prior art (MPEP 2141.01)
MOORE teaches “A method is provided for fabricating a microneedle or a
microneedle array using a mould (2) having at least a needle-forming cavity which comprises the step (A) of prefilling the needle-forming cavity with a solvent (1) before applying a microneedle-forming composition (3). The solvent (1) and microneedle-forming composition (3) are allowed to mix (step E) as a result of diffusion. The solvent is removed (step F), a flexible adhesive tape (4) can be applied on top of the mould (2), (step G), lifted (step H) so as to pull the microneedles out of the mould, giving an array of drug-filled dissolvable microneedles ready for application (step I).” (abstract, see whole document).
MOORE teaches that: “In connection with this embodiment, the microneedle-forming composition may comprise an active substance, such that when the microneedle dissolves upon application to the skin, the active substance is delivered into the underlying tissue of the subject.” ([0022]). And that: “The dissolvable material may be or comprise of one or a combination of materials selected from the following group: polymers, carbohydrates, cellulosics, sugars, polyols or alginic acid or a derivative thereof.” ([0023]). And further that: “The dissolvable material may comprise one or a combination of materials selected from the following: polyvinyl alcohol (PVA), polyvinyl pyrrolidone (PVP), raffinose, sucrose, trehalose, dextran, glycerine, CMC and sodium alginate.” ([0024])(instant claims 14-15, polyalcohol and glycerin). And further that: “The solvent used for dispersing the dissolvable material may, for example, be water, C2-C8 alcohol, or an organic solvent, or a mixture of solvents” ([0025])(instant claim 29).
MOORE teaches that: “Surface tension of the formulation may be altered by the addition of surfactants such as polysorbate, glycerol oleate and sodium dodecyl sulfate.” ([0087])(instant claims 14-15, non-ionic surfactant & polysorbate).
MOORE teaches that: “The volume occupied by the dried formulation may be for example in the range of 5-95% of the microneedle body volume. The remaining of the needle body (if any) and supporting disk are generally made of the different material(s) than those used for making the needle tip. The material used to make the rest of the needle body and the supporting disk may be chosen so that it is soluble in at least one solvent in which the first materials(s) exhibit poor solubility. For example, if the needle tip is made from formulation consisting of trehalose the rest of the needle body may be made of PVP dissolved in ethanol in which trehalose is insoluble.” ([0090])(instant claim 1, “polyvinylpyrrolidone […] wherein polyvinylpyrrolidone is the major constituent of the formulation”, and instant claims 14-15, disaccharide & trehalose). And that: “Suitable formulations may contain only one component or they can be mixtures of more than one component blended in any suitable ratio. Examples include the use of sugars such as trehalose or sucrose, and polymers such as polyvinyl alcohol (PVA) or PVP, alone or in combination.” ([0099]). And further that: “In addition to main components, suitable formulations for manufacturing of microneedles may optionally include one or more surfactants and/or stabilizing agents, such as amorphous glass-forming sugars.” ([0100]).
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of MOORE is that MOORE does not expressly teach (1) the inclusion of interferon for delivery to the skin; or (2) the amounts of ingredients included.
DEKKER teaches “The present invention relates to methods and devices for intradermal delivery of substances, preferably therapeutic substances by targeting the substance to the intradermal compartment of a subject's skin.” (abstract, see whole document, [0025], [0026]). DEKER teaches that: “By the use of "direct intradermal (ID) administration" means hereafter referred to as "dermal-access means", for example, using microneedle based injection and infusion systems […].” ([0011]). And that: “In some embodiments, the present invention encompasses delivering a substance into the intradermal compartment of a subject's skin using a device that comprises at least one needle, preferably a microneedle.” ([0022]).
DEKKER teaches that: “The methods of the invention are particularly useful for chronic administration of substances, e.g., therapeutic proteins which often result in an unwanted immune response upon chronic administration by other routes. Preferred substances for use in the methods of the invention are, cytokines (e.g., interferons, including interferon alpha and beta)” ([0064]). DEKKER particularly teaches delivery of interferons (p. 23, §5.3.2 Interferons) including specific beta interferons ([0169]). And that: “a unit dose of at least 10 µg, at least 20 µg, at least 30 µg, at least 50 µg, at least 100 µg, or at least 500 µg.” ([0172])(instant claims 12, 13, interferon amount of interferon, instant claim 31 beta interferon; instant claims 16-17 microneedle array for delivery of inteferon).
Dillon et al. teaches a Formulation and characterisation of dissolving microneedles for the transdermal delivery of therapeutic peptides (title, see whole document), and particularly that: “This study presents a dissolving MN system composed of polyvinylpyrrolidone (PVP) and trehalose to encapsulate active pharmaceutical peptides within the MN matrix.” (abstract).
Dillon et al. teaches that: “Peptides, proteins and antigens are all sensitive to temperature and require benign formulation conditions to avoid damaging their pharmaceutical activity ([…]). As such, encapsulation and solidification of MNs incorporating these drugs must be carried out at lower temperatures and in many cases, avoiding harsh environments such as high or low pH, high pressure and organic solvents ([…]). This study presents a dissolving MN system composed of biocompatible polymers and stabilising sugars to encapsulate active pharmaceutical peptides within the MN matrix. Rapid and systemic delivery is then achieved once the needles have penetrated the SC and dissolved in the interstitial fluid of the skin.” (p. 126, col. 1, last paragraph of §Introduction).
Dillon et al. teaches that: “Taking into account the experimental and statistical data obtained from this study, in addition to the data obtained from literature, it was determined that the optimum formulation would consist of a 3:1 formulation of PVP: trehalose, incorporating 2% w/w glycerol.” (p. 132, col. 1, 3rd paragraph)(instant claims 12, 14-22, 26-29, amounts of PVP, trehalose, and glycerin). And further that: “As such, the 3:1 PVP/trehalose MNs would be expected to successfully penetrate the skin without bucking or breaking given that the lowest fracture force measured was almost double the calculated upper insertion force required […].” (p. 132, col. 2, 2nd paragraph).
Regarding the specific amounts of ingredients composing the microneedle arrays, MOORE teaches the same constituent ingredients for the same use such that it would have been prima facie obvious to optimize the amounts of ingredients to form an efficacious microneedle array. Even so, MOORE teaches trehalose in amounts ranging from 25% to 50%, PVP at 50%, and Tween 80 (polysorbate) at 0.05 % (w/v) in Table 1. Additionally, Dillon et al. teaches microneedle formulations composed of PVP:Trehalose 3:1 incorporating 2% w/w glycerol as a plasticizer as an optimum formulation. To the extent that the amounts overlap with those claimed – “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.” (MPEP §2144.05-I), and to the extent that the ranges do not overlap – “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. "[W]here 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."” (MPEP §2144.05-II).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
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 produce a microneedle array for delivery of an interferon such as interferon beta, as suggested by DEKKER, the microneedle arrays including known constituent ingredients such as polyvinyl pyrrolidone (PVP), trehalose, polysorbate, and glycerin, to form the same as suggested by MOORE, to form an efficacious microneedle array for delivery of the interferon, in optimal amounts as suggested by Dillon et al. such as PVP:Trehalose 3:1 with 2% glycerol as a plasticizer, and polysorbate as a surfactant. Additionally, it would have been prima facie obvious to utilize a microneedle array for delivery of interferon as at alternative to conventional injections for better patient compliance.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention because it would have required no more than an ordinary level of skill to combine known ingredients to produce microneedle arrays for delivery to the user skin. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over MOORE in view of DEKKER and Dillon et al. as applied to claims 12-17, 19-22 and 25-29 above, and further in view of FREDRICKSON (US 2010/0222743 A1; published September, 2010).
Applicant claims
Applicant claims a microneedle array, comprising interferon and a completely soluble formulation including polyvinylpyrrolidone for use in the intradermal delivery of interferon, wherein polyvinylpyrrolidone is the major constituent of the formulation (instant claim 1). Applicant further claims the microneedle array comprising an applicator (instant claim 23), and wherein the applicator comprises a trigger device (instant claim 24).
Determination of the scope
and content of the prior art (MPEP 2141.01)
MOORE teaches methods for fabricating a microneedle or a microneedle array using a mould, as discussed above and incorporated herein by reference.
DEKKER teaches delivery of interferons via microneedle arrays, as discussed above and incorporated herein by reference.
Dillon et al. teaches a Formulation and characterisation of dissolving microneedles for the transdermal delivery of therapeutic peptides, as discussed above and incorporated herein by reference.
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings MOORE/DERREK is that MOORE/DERREK do not expressly teach an applicator device including a trigger for application of microneedle arrays.
FREDRICKSON teaches a microneedle array applicator (title, abstract, see whole document), and particularly that: “The applicator device 20 is also positioned against an application surface, and the opening 32 is positioned relative to a target site for patch delivery. Suitable sites for microneedle patch application on a patient's skin will vary, and the operator must select a suitable position and orientation of the applicator device 20. When the patch accelerating assembly 38 is energized, the patch 72 is fully mounted to the applicator device 20, and the device 20 is positioned relative to the target location, the operator then actuates the impactor 62 by releasing the energy stored in the torsion spring 68, which moves the impactor 62 toward the patch 72 along an arcuate path, which can correspond to the arcuate path defined by the slot 48 in the housing 22.” ([0045], Figures 5A & 5B). And that: “Release of the patch from its attachment to the holding mechanism and release of the leaf spring from its cocked position may then occur simultaneously by activating the trigger.” ([047]). FREDRICKSON further teaches that: “FIG. 6B shows the applicator device after the peelable seals 131, 132 have been removed. A trigger 137 is integrally formed in the top surface of the housing 122. The trigger is connected to the top surface of the housing at a single attachment point 139, thus allowing the trigger to be deflected downward by thumb or finger pressure as shown in FIG. 6D.” ([0049])(instant claims 23-24).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
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 produce a microneedle array for delivery of an interferon such as interferon beta, as discussed above, and further to utilize an applicator with trigger for delivery of the same as suggested by FREDRICKSON, for simplified placement (delivery) of the microneedle arrays.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention because it would have required no more than an ordinary level of skill to combine known ingredients to produce microneedle arrays for delivery to the user skin using a known application with a trigger. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
Claims 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over MOORE in view of DEKKER and Dillon et al. as applied to claims 12-17, 19-22 and 25-29 above, and further in view of DETERMAN (US 2013/0123707 A1; published May, 2013).
Applicant claims
Applicant claims a microneedle array, comprising interferon and a completely soluble formulation including polyvinylpyrrolidone for use in the intradermal delivery of interferon, wherein polyvinylpyrrolidone is the major constituent of the formulation (instant claim 1). Applicant further claims the microneedle array comprising an applicator (instant claim 23), and wherein the applicator comprises a trigger device (instant claim 24).
Determination of the scope
and content of the prior art (MPEP 2141.01)
MOORE teaches methods for fabricating a microneedle or a microneedle array using a mould, as discussed above and incorporated herein by reference.
DEKKER teaches delivery of interferons via microneedle arrays, as discussed above and incorporated herein by reference.
Dillon et al. teaches a Formulation and characterisation of dissolving microneedles for the transdermal delivery of therapeutic peptides, and that: “Peptides, proteins and antigens are all sensitive to temperature and require benign formulation conditions to avoid damaging their pharmaceutical activity ([…]). As such, encapsulation and solidification of MNs incorporating these drugs must be carried out at lower temperatures and in many cases, avoiding harsh environments such as high or low pH, high pressure and organic solvents ([…]).” [emphasis added](p. 126, col. 1, last paragraph of §Introduction), as discussed above and incorporated herein by reference.
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of MOORE/DERREK is that MOORE/DERREK does not expressly including a buffer solution.
DETERMAN teaches aqueous formulations for coating microneedle arrays (title, see whole document). DETERMAN teaches that: “In embodiments, the at least one API can be a composition of matter or mixture containing a component that is pharmacologically effective when administered in an amount of less than about 5 mg, and in some embodiments less than about 0.25 mg. Examples of such high potency APIs include, for example, […] interferon alpha, interferon beta, interferon gamma […].” ([0225]). And that: “In embodiments, disclosed aqueous formulations can include at least one buffer as an excipient. A buffer can generally function to stabilize the pH of the aqueous formulation. The particular buffer to be utilized can depend at least in part on the particular API (or APIs) that are included in the aqueous formulation. The pH of the aqueous formulation can be important, for example, to maintain the solubility of the API at a desired level. Generally, any commonly utilized buffers can be used in disclosed aqueous formulations. Exemplary buffers can include for example, […] acetate buffer […].” ([0228])(instant claim 30, the buffer is an acetate buffer).
DETERMAN further teaches the inclusion of trehalose ([0029], [0230]), polyvinyl pyrrolidone (PVP)([0233]), as well as polysorbate and glycerol (glycerin)([0236]).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
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 produce a microneedle array for delivery of an interferon, as discussed above, and further to include a buffer such as an acetate buffer as suggested by DETERMAN to stabilize the pH of the formulation.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention because it would have required no more than an ordinary level of skill to combine known ingredients to produce microneedle arrays for delivery to the user skin. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
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 §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 12-17 and 19-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,690,799 (hereafter ‘799). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are directed to a microneedle array comprising all of the same constituents now claim (polyvinyl pyrrolidone, interferon (beta), trehalose, glycerin, and polysorbate)
Instant claim 1 is discussed above.
‘799 claim 1 recites a microneedle array comprising interferon and a completely soluble formulation and the formulation comprises more than 35 wt % of polyvinylpyrrolidone with polyvinyl pyrrolidone being present in the formulation in the greatest amount compared to the other ingredients, more than 25 wt% of disaccharide, non-ionic surfactants, and polyalcohol. ‘799 claim 2 recites the polyalcohol is glycerin, the disaccharide is trehalose, and the surfactant is polysorbate.
The difference between the instantly rejected claims and the claims of ‘799 is that the instant claims are broader in terms of ingredient amounts.
It would have been prima facie obvious before the effective filing date of the claimed invention that the instantly rejected claims are an obvious variant of the claims of ‘799 because the claims are directed to microneedle arrays including the same constituent ingredients. The skilled artisan would have been motivated to modify the claims of ‘799 and produce the instantly rejected claim because for broader scope of patent claim coverage. Furthermore, the skilled artisan would have had a reasonable expectation of success in producing the invention of the instantly rejected claims because it would have required no more than an ordinary level of skill in producing the microneedle arrays including known ingredients such as polyvinyl pyrrolidone, interferon (beta), trehalose, glycerin, and polysorbate in amounts effective for delivery to the users skin.
Conclusion
Claims 12-17 and 19-31 are pending and have been examined on the merits.
The specification is objected to. Claims 12-17 and 19-31 are rejected under 35 U.S.C. 112(b); claims 12-13, 16-17, 19, 21, 23 and 29 are rejected under 35 U.S.C. 102(a)(1); claims 12-17 and 19-31 are rejected under 35 U.S.C. 103; and claims are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11,690,799. No claims allowed at this time.
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/IVAN A GREENE/Examiner, Art Unit 1619
/TIGABU KASSA/Primary Examiner, Art Unit 1619
1 Of record as cited on Applicant’s IDS dated 06/23/2023, NPL citation No. 1, copy provided in parent case 17/048,773 – 7-page NPL submitted 10/19/2020.
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