Prosecution Insights
Last updated: May 29, 2026
Application No. 17/918,771

ORAL THIN FILM WITH SMOOTH FUSED FILM

Non-Final OA §103§DOUBLEPATENT
Filed
Oct 13, 2022
Priority
Apr 15, 2020 — EU 20169697.8 +1 more
Examiner
RZECZYCKI, PHILLIP MATTHEW
Art Unit
1625
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Lts Lohmann Therapie-Systeme Age
OA Round
2 (Non-Final)
57%
Grant Probability
Moderate
2-3
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 57% of resolved cases
57%
Career Allowance Rate
58 granted / 101 resolved
-2.6% vs TC avg
Strong +45% interview lift
Without
With
+45.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
35 currently pending
Career history
161
Total Applications
across all art units

Statute-Specific Performance

§101
0.8%
-39.2% vs TC avg
§103
44.1%
+4.1% vs TC avg
§102
5.0%
-35.0% vs TC avg
§112
19.5%
-20.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 101 resolved cases

Office Action

§103 §DOUBLEPATENT
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 . Claims 6-8, 16-17 and 20 have been cancelled. Claims 1, 15 and 22 have undergone amendments. Thus, Claims 1-5, 9-15, 18, 19, and 21-22, submitted on 9 October 2025, represent all claims currently under consideration. 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. Response to Arguments The 35 U.S.C § 112(b) rejection of Claim 6 is withdrawn. Applicant has cancelled claim 6, rendering the rejection moot. The 35 U.S.C. 102(a)(1) rejection of Claims 1, 2, 4-9 and 19-12 over Bruce is withdrawn. The rejection is withdrawn as Bruce does not explicitly disclose the use of a water-insoluble, particulate API dispersed in the polymer matrix, nor does Bruce disclose all limitations of newly amended Claim 1. Applicant’s arguments, filed 21 October 2025, with respect to the rejection(s) of claims 1-15 and 18-22 under 35 U.S.C. § 103 over Yang (2008) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. Applicant has amended the claims to specify that the amount of polyethylene oxide in the OTF is 55 to 85% by weight, and further specifies the weight ratio of the matrix polymer to the API as in the range of 1.6/1 to 2.8/1, which was not defined in the prior claim set, nor was it found in any dependent claim. However, upon further consideration, a new ground(s) of rejection is made over Yang (2008) in view of Parthare (International Journal of Pharmaceutical Sciences Review and Research, 21(1), July-August 2013, 29, 169-178). Applicant states that Yang does not recite a surface roughness Ra of instant Claim 14, and that Yang rather teaches that particles are preferably not completely enclosed or embedded within the film, but remain exposed on the surface of the film. The Examiner respectfully disagrees. As described in the prior office action, Yang states that “desirably, the particles are embedded entirely within the finished films. In other words, the dry films of the present invention desirably have a smooth surface free of exposed agents or particles that could impart grittiness or maldistribution of the active ingredient. Thus, in one aspect of the invention there is provided a film vehicle which contains a uniform distribution of actives, as defined herein, being suitably free of particles” (Paragraph 0022). Applicant also claims that the limitations of Claim 15 were not sufficiently addressed in the prior office action. The Examiner respectfully disagrees that the limitations of Claim 15 were not addressed. Yang teaches the claimed method, and is described in the office action as follows: “Some embodiments provide a method of preparing a thin film drug delivery vehicle including: providing a pharmaceutically active/taste masking agent complex; combining the complex with a water-soluble polymer and a solvent to form a mixture with uniform distribution of the complex therein; casting the mixture onto a planar carrier surface to form a thin film on the carrier surface; and controllably drying the thin film to form a distribution variance of the complex having less than about 10% variance throughout any given area of the thin film” (Paragraphs 0031-0035). Applicant’s arguments, filed 21 October 2025, with respect to the rejection(s) of claims 1-15 and 18-22 under 35 U.S.C. § 103 over Schobel in view Yang (2008) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. Applicant has amended the claims to specify that the amount of polyethylene oxide in the OTF is 55 to 85% by weight, and further specifies the weight ratio of the matrix polymer to the API as in the range of 1.6/1 to 2.8/1, which was not defined in the prior claim set, nor was it found in any dependent claim. However, upon further consideration, a new ground(s) of rejection is made over Schobel in view of Yang (2008) and Parthare (International Journal of Pharmaceutical Sciences Review and Research, 21(1), July-August 2013, 29, 169-178). The Examiner respectfully disagrees that the limitations for claim 15 were not addressed, as described previously The 35 U.S.C. § 103 rejection of Claims 1-15 and 18-22 over Yang (2006) is withdrawn. Applicant has amended the claims to specify that the amount of polyethylene oxide in the OTF is 55 to 85% by weight, and further specifies the weight ratio of the matrix polymer to the API as in the range of 1.6/1 to 2.8/1, which is not taught by Yang, nor does Yang teach the surface roughness of the thin films of the examined application. The non-statutory double patenting rejection of Claims 1-15 and 18-20 over co-pending application 17/918,780 is withdrawn as the claims of the co-pending application have been amended. However, a new grounds of rejection for Claims 1-5, 9-13, 18-19, and 21 over claims 1-4, 7, 9, 10, 21, and 24-25 (amended claims of 23 October 2025) is made. Claim Objections Claim 22 is objected to because of the following informalities: Claim 22 has undergone an amendment and this is not indicated in the presently submitted set of claims. It appears Claim 22 was amended from the claims of 27 March 2023 to read “wherein the surface roughness Ra on both sides of the oral thin film is less than 0.3 pm” when the original claim read “wherein the surface roughness Ra on both sides of the oral thin film is less than 0.3 µm”. Appropriate correction is required. Claim Rejections - 35 USC § 103- NEW GROUNDS OF REJECTION 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 1-5, 9-15, 18, 19, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Yang (US 2008/0044454; Publication Date: 21 February 2008) in view of Parthare (International Journal of Pharmaceutical Sciences Review and Research, 21(1), July-August 2013, 29, 169-178). Yang (See IDS, 13 October 2022) discloses a rapid dissolving thin film drug delivery composition for the oral administration of active components. The compositions may be formed by wet casting methods, where the film is cast and controllably dried, or alternatively by extrusion method (Abstract). In the wet casting method, the film product is formed by combining a polymer and a polar solvent, forming the combination into a film, and drying the film in a controlled manner (Paragraph 0015). The films may be formed with a polar solvent which may be water, a polar organic solvent, or a combination thereof. An active ingredient may be added to the polymer and water combination prior to the drying step. Moreover, the composition is desirably mixed in a manner to minimize the incorporation of air into the mixture and is desirably de-aerated, such as by conditioning at room temperature to allow trapped air to escape prior to the drying process (Paragraph 0016). Desirably, the particles are embedded entirely within the finished films. In other words, the dry films of the present invention desirably have a smooth surface free of exposed agents or particles that could impart grittiness or maldistribution of the active. Thus, in one aspect of the invention there is provided a film vehicle which contains a uniform distribution of actives, as defined herein, being suitably free of particles (Paragraph 0022). Some embodiments provide a method of preparing a thin film drug delivery vehicle including: providing a pharmaceutically active agent/taste-masking agent complex; combining the complex with a water-soluble polymer and a solvent to form a mixture with uniform distribution of the complex therein; casting the mixture onto a planar carrier surface to from a thin film on the carrier surface; and controllably drying the thin film to form a distribution variance of the complex having less than about 10% variance throughout any given area of the thin film (Paragraphs 0031-0035). Among the polymers recited in the specification, polyethylene oxide (PEO) when used alone or in combination with a hydrophilic cellulosic polymer is particular suited to hot extrusion process and achieves flexible strong films. Moreover, these films are sufficiently flexible when substantially free of organic solvents. As such, if there is no solvent present, then there is no plasticizer in the films (Paragraph 0105). To achieve the desired film properties, the level and/or molecular weight of the PEO in the polymer component may be varied. Modifying the PEO content affects properties such as tear resistance, dissolution rate, and adhesion tendencies. Thus one method for controlling film properties is to modify the PEO content. By modifying the content of the polymer component, the desired dissolution characteristics can be achieved (Paragraph 0106). In accordance with the present invention, PEO desirably ranges from about 20% to 100% by weight in the polymer component (Paragraph 0107). In some embodiments, it may be desirable to vary the PEO levels to promote certain film properties. To obtain films with high tear resistance and fast dissolution rates, levels of about 50% or greater of PEO in the polymer component are desirable. To achieve adhesion prevention, i.e., preventing the film from adhering to the roof of the mouth, PEO levels of about 20% to 75% are desirable. In some embodiments, adhesion to the roof of the mouth may be desired. In such cases higher levels of PEO may be employed (Paragraph 0109). The molecular weight of the PEO may also be varied. High molecular weight PEO such as about 4 million, may be desired to increase mucoadhesivity of the film. More desirably, the molecular weight may range from about 100,000 to 900,000, more desirably from about 100,000 to about 600,000, and most desirably from about 100,000 to 300,000 (Paragraph 0110). The active components that may be incorporated into the films of the present invention include without limitation pharmaceutical and cosmetic actives, drugs, medicaments, proteins, antigens or allergens, mouthwash components, flavors, fragrances, enzymes, preservatives, sweetening agents, colorants, spices, vitamins, and combinations thereof (Paragraph 0150). A wide variety of medicaments, bioactive substances and pharmaceutical compositions may be included in the dosage forms of the present invention. Examples of use drugs include… cholinesterase inhibitors…anti-inflammatory agents… dopamine receptor agonists…psychotherapeutic agents…anti-inflammatory substances…analgesics… (Paragraph 0151). Analgesics include opiates and opiate derivatives, such as oxycodone, ibuprofen, aspirin, acetaminophen, and combinations thereof that may optionally include caffeine (Paragraph 0153). Also contemplated for use herein are non-steroidal anti-inflammatories (NSAID’s) such as diclofenac and etodolac…(Paragraph 0154). The film products of the present invention are capable of accommodating a wide range of amounts of the active ingredient. The films are capable of providing an accurate dosage amount (determined by the size of the film and concentration of the active in the original polymer/water combination) regardless of whether the required dosage is extremely high or extremely low. Therefore, depending on the type of active or pharmaceutical composition that is incorporated into the film, the active amount may be as high as about 300 mg, desirably up to about 150 mg or as lows at the microgram range, or any amount in between (Paragraph 0163). The film products are generally formed by combining a properly selected polymer and polar solvent, as well as any active ingredient or filler as desired. Desirably, the solvent content of the combination is at least 30% by weight of the total combination. The matrix formed by this combination is formed into a film, and then dried. The resulting film will desirably contain less than about 10% by weight solvent, more desirably less than about 8% by weight solvent, even more desirably less than about 6% by weight solvent, and most desirably less than about 2%. The solvent may be water, a polar organic solvent including, but not limited to, ethanol, isopropanol, acetone, methylene chloride, or any combination thereof (Paragraph 0196). When the matrix is formed including the film forming polymer and polar solvent in addition to any additives and the active ingredient, this may be done in a number of steps. For example, the ingredients may all be added together or a premix may be prepared (Paragraph 0197). A number of techniques may be employed in the mixing stage to prevent bubble inclusions in the final film. To provide a composition mixture with substantially no air bubble formation in the final product, anti-foaming or surface tension reducing agents are employed. The speed of the mixture is desirably controlled to prevent cavitation of the mixture in a manner which pulls air into the mix (Paragraph 0207). Anti-foaming and/or de-foaming components may be used with the films of the present invention. These components aid in the removal of air from the film-forming compositions. Entrapped air may lead to non-uniform films. Simethiocone is one particularly useful anti-foaming and/or defoaming agent, but the present invention is not so limited and other agents that are suitable may be used (Paragraph 0213). The wet film may be dried using controlled bottom drying or controlled microwave, desirably in the absence of external air currents (Paragraph 0219). The films of the present invention are desirably dried for 10 minutes or less. Drying the films at 80°C for 10 minutes produces a temperature differential of about 5°C. In many cases, however, drying times of less than 10 minutes are sufficient. (Paragraph 0229). Further examples of additives are plasticizers which include polylalkene oxides, such as polyethylene glyocols, polypropylene glycols, organic plasticizers with low molecular weights such as glverol, glycerol monoacetate, diacetate or triacetate, triacetin, polysorbate, cetyl alcohol, propylene glycol, and the like, added in concentrations ranging from about 0.5% to about 30%, and desirably ranging from about 0.5% to about 20% based on the weight of the polymer (Paragraph 0250). Table 4 provides a formulation wherein 95% ethanol was used (Ethanol in a 95:5 mix with water) (Paragraph 0299). Table 6 provides a formulation which utilizes 60/40 ethanol:water (Table 6, Paragraph 0308). Table 11 (Paragraph 0333) provides a formulation wherein the plasticizer is propylene glycol. Yang does not disclose an oral thin film wherein the amount of PEO is between 55 to 85% by weight, and wherein the weight ratio of the matrix polymer to the API is in the range of 1.6/1 to 2.8/1. Parthare provides a review of polymers commonly used in fast disintegrating oral films. Fast dissolving films are prepared using hydrophilic polymers that rapidly dissolve on the tongue or buccal cavity, delivering the drug to the systemic circulation via dissolution when contact with liquid is made. Water-soluble polymers are used as film formers for fast dissolving films. The water-soluble polymers achieve rapid disintegration, good mouth feel, and mechanical properties to the films (Abstract). Oral thin films (OTFs) offer fast, accurate dosing in a safe, efficacious format that is convenient and portable, without the need for water or measuring devices. OTFs are typically the size of a postage stamp and disintegrate on a patient’s tongue in a matter of seconds for rapid release of one or more APIs. The most essential ingredient which helps in film formation is the polymer. A variety of polymers are available for the preparation of a fast dissolving film. As the strip forming polymer is the most essential and major component of the FDF, at least 45% w/w of polymer should generally be present based on the total weight of dry film but typically 60 to 65% w/w of polymer is preferred to obtain desired properties (Introduction). One commonly used polymer is polyethylene oxide (PEO). Molecular weights range from 100,000 to about 8,000,000. They exhibit many properties that are typical of other classes of water-soluble polymers-lubricity, binding, water retention, thickening, and film formation. PEO water-soluble resins can be formed into flexible films by both thermoplastic processing and casting techniques. Such films may be made of PEO water-soluble resins alone or blended with a wide variety of other polymers, such as polyethylene, polystyrene, polycaprolactone, ethylene vinyl acetate, and nylon (Page 174). Yang and Parthare are considered analogous to the claimed invention as all are involved in the development of oral thin films containing active pharmaceutical ingredients. Therefore, it would have been prima facie obvious to one of ordinary skill in the art the time of the effective filing date of the instant application to modify the oral thin film of Yang which contains an insoluble API such as ibuprofen by adjusting the amount of PEO to between 55 and 85% by weight, and the ratio of PEO/API to the claimed ranges as Parthare demonstrates that typically 60 to 65% w/w of polymer is preferred to obtain desired properties. The alteration of the amount of PEO and ratio to API is prima facie obvious routine optimization within prior art conditions or through routine experimentation (See MPEP § 2144 II (A)). The artisan would be motivated to alter this amount of PEO in order to obtain optimal properties of the thin oral film, such as tear resistance, dissolution rate, and adhesive properties, as Yang states that the amount of PEO can alter these properties of the thin oral film. With respect to the melting point of the polyethylene oxide, the molecular weight of the polyethylene oxide controls its melting point, and as such, the melting point would be an inherent property of the polyethylene oxide that possesses those molecular weights. With respect to the specific ratio of drug to polymer, Yang teaches that these formulations can contain a broad range of amounts of therapeutic compound; therefore, the specific ratio of the drug:polymer could be arrived at through the teachings of Yang through routine experimentation and optimization. With respect to the inclusion of plasticizers, Yang teaches that when no solvents are used in the formation of the film, plasticizers are not necessary. However, for the development of the films utilizing compounds which are poorly soluble in water, organic solvents will be necessary, and in view of the teachings of Yang, plasticizers will be required in the formulation. Regarding the surface roughness, Yang states that the particles are embedded entirely within the finished films, and that the films of the invention desirably have a smooth surface free of exposed agents or particles that could impart grittiness or maldistribution of the active pharmaceutical ingredient. Claims 1, 4, 9-15, and 18, 19, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Schobel (US 2020/0101009; Publication Date: 2 April 2020) in view of Yang (US 2008/0044454; Publication Date: 21 February 2008) and Parthare (International Journal of Pharmaceutical Sciences Review and Research, 21(1), July-August 2013, 29, 169-178). Schobel discloses an oral film in an individual unit dose for delivery of one or more actives is disclosed, the film having a precisely calculated and controlled active dissolution profile (Abstract). One embodiment is found in Table 1 (Page 37) of an oral film containing the drug clobazam and 53.80 weight % of polyethylene oxide. This formulation contains 12.5 weight % of the active pharmaceutical ingredient, and is found in a ratio of 1:4.3 with respect to the PEO. This formulation also contains the plasticizer cellulose ether. Schobel fails to disclose an oral thin film wherein the amount of PEO is between 55 to 85% by weight, and wherein the weight ratio of the matrix polymer to the API is in the range of 1.6/1 to 2.8/1. The teachings of Yang and Parthare are fully described and are fully incorporated into this rejection. Schobel, Yang and Parthare are considered analogous to the claimed invention as all are involved the development of smooth oral film formulations for the delivery of drugs. Therefore, it would have been prima facie obvious to one of ordinary skill in the art the time of the effective filing date of the instant application to apply the specific PEO, plasticizers, and solvents of Yang to the formulations of Schobel, and further optimize the exact amounts and ratios of each ingredient in view of the teachings of Parthare to arrive at the claimed formulations of the examined application. The use of the methods and specific PEO, plasticizers, and solvents of Yang to produce the formulations of Schobel, arriving at the formulations of the claimed invention, is prima facie obvious combination of prior art elements according to known methods to yield predictable results (See MPEP § 2143 I (A)); Schobel teaches smooth oral film formulations, and Yang teaches that by altering the PEO, oral films with properties that lead to enhanced delivery of the drug can be developed. The artisan would recognize this, and would be motivated to combine these teachings in order to develop a formulation that has optimal dissolution, adhesion or tear properties, allowing for improved delivery of the drug to the patient. The alteration of the amount of PEO and ratio to API is prima facie obvious routine optimization within prior art conditions or through routine experimentation (See MPEP § 2144 II (A)). The artisan would be motivated to alter this amount of PEO in order to obtain optimal properties of the thin oral film, such as tear resistance, dissolution rate, and adhesive properties, as Yang states that the amount of PEO can alter these properties of the thin oral film. With respect to the melting point of the polyethylene oxide, the molecular weight of the polyethylene oxide controls its melting point, and as such, the melting point would be an inherent property of the polyethylene oxide that possesses those molecular weights. 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 1-5, 9-13, 18-19, and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7, 9, 10, 21, and 24-25 of copending Application No. 17/918,780 (amended claims of 23 October 2025). Claim 1 of ‘780 is directed to an oral thin film, comprising a polymer matrix and ulipristal acetate as an active agent, wherein the ulipristal acetate is dispersed in the polymer matrix and the polymer matrix is a matrix of a water-soluble polymer selected from a group which includes poly(ethylene oxide), wherein in the case where the water-soluble polymer is selected from the group which includes PEO, the amount of water-soluble polymer is 40 to 70% by weight, based on the total weight of the oral thin film. Claim 2 of ‘780 is directed to the oral thin film of claim 1 wherein the ulipristal acetate is micronized ulipristal acetate. Claim 3 of ‘780 is directed to the oral thin film according to claim 1 wherein the amount of ulipristal acetate is 10 to 60% by weight based on the total weight of the film. Claim 4 of ‘780 is directed to the oral thin film according to claim 1, wherein when the water-soluble polymer is PEO, the amount of ulipristal acetate is 10 to 60% by weight based on the total weight of the oral thin film. Claim 7 of ‘780 is directed to the oral thin film according to claim 1, wherein the PEO has a molecular weight in the range of 50,000 to 200,000 Dalton. Claim 9 of ‘780 is directed towards the oral thin film according to claim 1 further comprising one or more plasticizers comprising glycerol. Claim 10 of ‘708 is directed to the oral thin film according to claim 1 wherein the oral thin film is a non-foamed film or a foamed film. Claim 21 of ‘780 is directed to the oral thin film of claim 1, wherein the water-soluble polymer is PEO. Claim 24 of ‘780 is directed to the oral thin film of claim 21 wherein the PEO has a molecular weight of 50,000 to 200,000 Dalton. Claim 25 of ‘780 is directed to the oral thin film of claim 21 wherein the PEO has a molecular weight of 75,000 to 150,000 Dalton. The claims at issue are not identical, but are not patentably distinct because the formulations of the examined application can be arrived upon using the limitations set forth in the claims. Claims 1-5, 9-13, 18-19, and 21 of the examined application are product by process claims. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979) (See MPEP § 2113 I). This is a provisional nonstatutory double patenting rejection. Conclusion Claims 1-5, 9-15, 18, 19, and 21-22 are rejected. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP MATTHEW RZECZYCKI whose telephone number is (703)756-5326. The examiner can normally be reached Monday Thru Friday 730AM-5PM EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /P.M.R./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
Read full office action

Prosecution Timeline

Oct 13, 2022
Application Filed
Jul 10, 2025
Non-Final Rejection mailed — §103, §DOUBLEPATENT
Oct 09, 2025
Response Filed
Nov 18, 2025
Final Rejection mailed — §103, §DOUBLEPATENT
Feb 18, 2026
Response after Non-Final Action

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Prosecution Projections

2-3
Expected OA Rounds
57%
Grant Probability
99%
With Interview (+45.0%)
3y 5m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 101 resolved cases by this examiner. Grant probability derived from career allowance rate.

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