DETAILED ACTION
The receipt is acknowledged of applicant’s amendment and request for RCE filed 02/11/2026.
Claims 1-4 and 6-7 are pending and subject of this office 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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/11/2017 has been entered.
Double Patenting
It is noted that numerous patents and copending applications of Applicants encompass the same or similar subject matter of the instant application. Applicant should review all subject matter which are same or similar and amend the claims or submit terminal disclaimers for each and every one considered to contain similar subject matter.
Claim Rejections - 35 USC § 112
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.
Claim 4 is 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 4 recites the expression “botanical”, and the specification gives no guidance to one of ordinary skill in the art regarding “botanical”. The specification does not describe the expression, except for tetrahydrocannabinol (THC) and cannabidiol as botanical material. The expression is claimed without partial or complete description of any botanical, except for cannabidiol and THC. This does not convey to one of ordinary skill in the art that applicants were in possession of the claimed subject matter. The expression is recited without enumeration of reasonable number of botanicals, and therefore the expression does not meet the written description requirement for the broadly claimed expression. One of ordinary skill in the art could not recognize or understand the expression from its mere recitation. Limitations at the point of novelty, such as applicants’, neither provide those elements required to practice the inventions, nor “inform the public” during the life of the patent of the limits of the monopoly asserted. The expressions could encompass myriad botanical materials and their derivatives, known and unknown, and applicants claimed expression represent only an invitation to experiment regarding all possible botanical and all possible derivatives of botanicals that may comprise large molecules of any botanical material with polymers, etc.
To satisfy the Written description requirement, applicant must convey with reasonable clarity to one skilled in the art, as of the filing date that applicant were in possession of the claimed invention. Vas-Cath Inc. v Mahurkar, 19 USPQ 2d 1111. The invention is, for purpose of the “written description” inquiry, whatever is now claimed (see page 1117). The specification does not clearly allow person of ordinary skill in the art to recognize that [he or she] invented what is claimed (see Vas-Cath at page 116). One cannot describe what one has not conceived. See Fiddes v Baird, 30 USPQ2d 1481, 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class, the specification provided only bovine sequence.
Regarding the requirement for adequate written description of chemical entities, Applicants' attention is directed to MPEP § 2163. In particular, Regents of the University of California v. Eli Lilly & Co., 119 F. 3d 1559, 1568 (Fed. Cir. 1997), cert denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), holds that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, "not a mere wish list or plan for obtaining the claimed chemical invention." Eli Lilly, 119 F. 3d at 1566. The Federal Circuit has adopted the standard set forth in the Patent and Trademark Office ("PTO") Guidelines for Examination of Patent Applications under the U.S.C. 112.1 "Written Description" Requirement ("Guidelines"), 66 Fed. Reg. 1099 (Jan. 5, 2001), which state that the written description requirement can be met by "showing that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics," including inter alia, "functional characteristics when coupled with a known or disclosed correlation between function and structure..." Enzo Biochem Inc. v. Gen-Probe Inc., 296 F. 3d 316, 1324-25 (Fed. Cir. 2002) (quoting Guidelines, 66 Fed. Reg. At 1106 (emphasis added)). Moreover, although Eli Lilly and Enzo were decided within the factual context of DNA sequences, this does not preclude extending the reasoning of those cases to chemical structures in general. Univ. of Rochester v. G.D. Searle & Co., 249 Supp. 2d 216,225 (W.D.N.Y. 2003).
With the exception of the disclosed “botanicals”, the skilled artisan cannot envision the detailed botanicals encompassed by claim. Adequate written description requires more than a mere statement that it is part of the invention.
Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood , 107 F.3d at 1572, 41 USPQ2d at 1966.
As outlined in Univ. of Calf. V. Eli Lilly, 43 USPQ 2d 1398, 1406 (Fed. Cir. 1997), a description of a genus can comprise a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. This is analogous to enablement of a genus under Section 112, Para. 1, by showing the enablement of a representative number of species within the genus. Mere indistinct terms (here the words “botanical”), however, may not suffice to meet the written description requirement.
A genus such as “botanical” can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has substantial variance, the disclosure must describe a sufficient number of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not specifically define what constitutes a representative number of species, courts have indicated what does not constitute same. See, e.g., In re Gostelli, 10 USPQ 2d 1614, 1618 (Fed. Cir. 1989), holding that the disclosure of two compounds within a subgenus did not adequately describe such subgenus.
The instant specification does not describe specific botanicals. Accordingly, the claimed expression as used currently by instant claim 4 is deemed so indistinct that it fails to reasonably convey to one skilled in the art that applicant was in possession of a representative number of species within that genus.
To satisfy the written description requirement, the applicant does not have to utilize any particular form of disclosure to describe the subject matter claimed, but the description must clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed. Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541 F.3d 1115, 1122 (Fed.Cir.2008) (quoting In re Alton, 76 F.3d 1168, 1172 (Fed.Cir. 1996)). In other words, the applicant must `convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and demonstrate that by disclosure in the specification of the patent.
Written description requirement, serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed. Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). The requirement serves a teaching function, as a quid pro quo in which the public is given meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time. (Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 922 (Fed.Cir.2004) (quoting Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 970 (Fed.Cir.2002)). A patentee can lawfully claim only what he has invented and described, and if he claims more his patent is void; Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345-46 (Fed.Cir.2000). The purpose of the written description requirement] is to ensure that the scope of the right to exclude and does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.
Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods,"). Where the specification provides only constructive examples in lieu of working examples, it must still "describe the claimed subject matter in terms that establish that the applicant was in possession of the claimed invention, including all of the elements and limitations." Id. (citing Hyatt v. Boone, 146 F.3d 1348, 1353 (Fed. Cir. 1998)).
Federal Circuit decision in Ariad Pharmaceuticals, Inc v. Eli Lilly. 598 F. 3d 1336 - Court of Appeals, Federal Circuit, 2010 – It explains that the written description requirement applies to both original and amended claims. It had further explained that the test for written description is “possession as shown in the disclosure” and embraced past ways for judging the adequacy of the disclosure, including whether the specification discloses a representative number of species, sufficient structure, and/or a sufficient correlation of function to structure.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See, e.g., In re Wilder, 22 USPQ 369, 372-3 (Fed. Cir. 1984). (Holding that a claim was not adequately described because the specification did ‘little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.’)
The test for determining compliance with the written description requirement is whether the disclosure of the application as originally filed reasonably conveys to one skilled in the art that the inventor had the possession at the time of the later claimed subject matter, rather than the presence or absence of literal support in the specification for the claimed language. See In re Kaslow, 707 F 2d 1366, 1375 (Fed. Cir. 1983). See MPEP 2163.06.
The written description requirement prevents applications from using the amendment process to update the disclosure in their disclosures (claims or specification) during the pendency before the patent office. Otherwise applicants could add new matter to their disclosures and date them back to their original filing date, thus defeating an accurate accounting of the priority of the invention. See 35 USC 132. The function of description requirement is to ensure that the inventor had possession, as of filing date of the application relied on, the specific subject matter claimed by him. See Genetech, 108 F 3d 1361, 1365 (Fed. Cir. at 1366, 78, 1999).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4, 7 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 2005/0037055) in view of Myers et al. (US 2012/0076921), and optionally Bunick et al. (US 2009/0060983), all references are of record in the parent application.
Applicant Claims
Claim 1 is directed to an oral soluble film containing at least one active agent, the oral soluble film being made by a method comprising continuously stirring an emulsion of a film forming composition and at least one active agent in a tank; depositing the emulsion separately into each of a plurality of wells while continuously stirring the emulsion in the tank, the emulsion of the film forming composition and the at least one active agent forming a contact angle with the well of less than 90O, wherein the emulsion flows into a film in the well within 20 seconds; and drying the film using hot air currents to form the oral soluble film containing the at least one active agent.
NOTE: The present claim is directed to product by process claims, and product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. 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), wherein the product-by-process claim was rejected because the end product, in both the prior art and the claimed product were the same. 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).
However, for completeness of record, every effort will be made to search and consider the claimed process.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Yang teaches non-self-aggregated uniform soluble film for oral drug delivery comprising drug suspension or emulsion in film forming polymer (abstract; ¶¶ 0014-0018, 0062, 0209-0211). The reference teaches process of making the film comprising the steps of forming a stable emulsion or suspension by mixing film forming agent and drug particulate just prior to casting the film, and drying the film (¶¶ 0079, 0080, 0082, 0111, 0112, 0148). The mixture of film forming polymers and drug has low viscosity so that it has very rapid structural recovery, and the film is formed during processing, so that particles settling and sedimentation are retarded (¶¶ 0075-0078). The reference teaches casting the film is predetermined individual wells (¶¶ 0189, 0226). The film is dried by heat, and the used temperature is controlled to prevent deleterious effect of heat on active component (¶ 0089). Drying using hot air flow is taught (¶ 0098). Film forming polymers include water soluble polymers including cellulose and cellulose derivatives, e.g. hydroxypropyl methyl cellulose Arabic gum, acacia gum, etc., (¶ 0105) that all used by applicants to practice the present invention and disclosed at paragraph [0313] of the published application. Yang prefers polymers of lower viscosities, as low as 400 cps (¶ 0111), and applicants desired to have viscosity of less than 600 cps, paragraph [0069] of the published application. The reference teaches plants and derivatives of plants as active agent to be included in the film (¶ 0144). The film comprising taste masking agent (¶¶ 0097, 0127, 0246, 0263, 0264, 0265, 0267).
Regarding “continuous stirring” claimed by claim 1, this is implied by the reference that teaches continuous stirring to eliminate air, ….the composition stirred till deposition…., and the film is formed during processing (¶¶ 0240, 0248).
Regarding the emulsion flows into film within 20 seconds as claimed by claim 1, Yang teaches the same film forming polymers used by applicants to practice the present invention, and teaches viscosity of the polymers as low as 400 cps, and applicants desired to have viscosity of less than 600 cps that falls within the viscosity range taught by Yang. Therefore, in the light of teaching of Yang, the claimed film forming suspension comprising the active agent is expected to flow into film within 20 seconds as claimed.
Regarding the claimed hot air drying claimed by claim 1, it is taught by Yang.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Yang teaches the claimed oral soluble film, and suggests the steps of making the film by method similar to the claimed method, the reference does not teach a step of forming a contact angle with the well of less than 90 degrees as claimed by claim 1.
Myers teaches method of making oral soluble film dosage for drug delivery. The drug is uniformly distributed throughout the film. The film comprises the film forming polymers used by applicants, and polymers have viscosity of 400 cps. In the process of making the film, during depositing the film, it is important to achieve a balance between adhesion and cohesion by achieving contact angle less than 90 degrees, since contact angles greater than 90 degrees indicate no or low "wetting" of deposition surface. To achieve the most optimal degree of wetting, the contact angle may be between 0 and 90 degrees. The reference teaches stirring of the ingredients and teaches plant derivatives as active agents in the film (¶¶ 0005, 0006, 0016-0018, 0051, 0054, 0059, 0100, 0134, 0147, 0151, 0155, 0161, 0163).
Bunick teaches method of making orally disintegrating dosage form to deliver active agents with no compression force. The dosage form is made by introducing a flowable material into recesses of a tray with an angle of repose (contact angle) between 20 to 44 degree (title, abstract; ¶¶ 0011, 0012, 0059).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide an oral soluble film comprising emulsion of film forming polymer and drug deposited into wells by the steps taught by Yang, and form a contact angle between the suspension and surface of the well of less than 90 degrees as taught by Myers. One would have been motivated to do so because Myers teaches to achieve the most optimal degree of wetting, the contact angle may be between 0 and 90 degrees to achieve a balance between adhesion and cohesion, and because contact angles greater than 90 degrees indicate no or low "wetting" of the surface on which the composition is deposited. One would reasonably expect formulation an orally soluble film by forming a emulsion or suspension comprising film forming polymer and drug particulate deposited into wells by the steps taught by Yang, and further form contact angle of less than 90 degree between the suspension and the surface of the wells wherein balance between adhesion and cohesion of the composition and the well is achieved.
Further, one having ordinary skill in the art would have been motivated to deposit the active agent emulsion or suspension in the wells as taught by the combination of Yang and Myers at a degree of 20-44 as taught by Bunick because Bunick teaches suitability of such angle to form orally disintegrating dosage form without use any compression force.
Since the claimed product appears to be substantially identical to that of the prior art, the burden is shifted to applicant to show an unobvious difference between the claimed product and the prior art product and to come forward with evidence establishing an unobvious difference. The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974); In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983); Ex parte Gray, 10 USPQ2d 1922 (Bd. Pat. App. & Inter. 1989). It has been held that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
All the limitations of claim 1 are suggested by combination of the cited references.
Regarding claim 2 that the film is formed in the well without mechanical intervention, the cited references do not teach any mechanical intervention after the mixture of the ingredients is deposited in the wells. Bunick further teaches depositing the orally disintegrating dosage form in a recess without any compression force.
Regarding botanical as claimed by claim 4, Yang teaches plants and plant derivatives as active agents.
Regarding bitter masking agent as claimed by claim 4, Yang teaches taste masking agent.
Regarding the three dimensional shape of the well that attributes to the bottom of the film as claimed by claim 7, it is obvious that a well is three dimensional structure, and applicants failed to show unexpected results obtained from the claimed three dimensional shape that attributes to the bottom of the film. It has been held by the court that aesthetic changes that have no mechanical function cannot be relied upon to patentability distinguish the claimed invention from the prior art. See In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947).
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. 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 invention.
Claims 3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Yang, Myers, and optionally Bunick as applied to claims 1-2, 4 and 7 above, and further in view of Nadal Rours (US 2016/0214920, of record).
Applicant Claims
Claim 3 recites the active agent is tetrahydrocannabinol (THC) and claim 6 recites the active agent is marijuana derivatives.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The combined teachings of Yang and Myers, and optionally Bunick, are previously discussed in this office action.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Yang teaches plants and their derivatives, the reference does not explicitly teach THC claimed by claim 3 or cannabidiol claimed by claim 6.
Nadal Rours teaches cannabis (marijuana) derivatives can be delivered orally from orally soluble film that are rapidly dissolving (abstract; ¶¶ 0083, 0086, 0097). Cannabis derivatives include cannabidiol and THC (¶¶ 0020, 0043, 0054, 0066, 0067).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide oral soluble film to deliver plant derivatives as taught by the combination of Yang and Myers, and optionally Bunick, and use the oral soluble film to deliver cannabidiol and THC as taught by Nadal Rours. One would have been motivated to do so because Nadal Rours teaches such oral soluble film is fast dissolving and suitable to deliver cannabidiol and THC. One would reasonably expect formulating oral soluble film comprising cannabidiol and THC that rapidly dissolve in the oral cavity and therefore provides rapid onset effect to the person in need thereof.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. 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 present invention.
Response to Arguments
Applicant's arguments filed 02/11/2026 have been fully considered but they are not persuasive.
Rejection under 35 U.S.C. §103 (a)
Applicants disagree with the examiner "Examples M-O of Yang clearly teach mixing the ingredients of the film forming agent then dividing them among individual wells, as applicants had done." Applicants argue that paragraph [0226] of the Yang publication does state: “An alternative method of preparing films which provides an accurate dosing may be used for any of inventive compositions A-I. The method begins with first combining the ingredients with mixing. The combination of ingredients is then divided among individual wells or molds. In such a method, aggregation of the components during drying is prevented by the individual wells.” While paragraph [0226] appears under the heading "Examples M-O," it actually describes a possible alternative to Examples A-I, not Examples M-O. Rather, the process steps for Examples M-O are described in paragraph [0227] as "…formed into a film by casting the combination of ingredients onto the glass surface and applying heat to the bottom side of the glass”.
In response to this argument, it is argued that regardless which example the reference teaches deposition of the composition into a well, the reference suggests casting the composition comprising the active agent into wells on paragraphs [0189] and [0226]. It is noted that the reference teaches more than one alternative embodiments, e.g. film composition casted on a glass surface, and wells filled with the composition. The disclosure of desirable alternatives does not necessarily negate a suggestion for modifying the prior art to arrive at the claimed invention. In In re Fulton, 391 F.3d 1195, 73 USPQ2d 1141 (Fed. Cir. 2004). In Ruiz v. A.B. Chance Co., 357 F.3d 1270, 69 USPQ2d 1686 (Fed. Cir. 2004), The court found motivation to combine the references to arrive at the claimed invention in the “nature of the problem to be solved” because each reference was directed “to precisely the same problem.” Id. at 1276, 69 USPQ2d at 1690. The court also rejected the notion that “an express written motivation to combine must appear in prior art references….” Id. at 1276, 69 USPQ2d at 1690. Further, Disclosed examples and preferred embodiments do not constitute a teaching away from broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). “A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994). Furthermore, “[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
Applicants argue that the claimed product by process is not disclosed in Yang. The final office action refers to paragraphs [0240] and [0248] of Yang for teaching continuous stirring. However, paragraph [0240] of Yang merely discloses "Composition T was stirred slowly for 45 min. to deaerate the mixture. The elimination of air from the film as a result of the slow stirring also contributed to the uniformity of the final film product and the faster drying time." Paragraph [0240] of Yang does not disclose depositing an emulsion separately into each of a plurality of wells while continuously stirring the emulsion in the tank. Paragraph [0248] of Yang discloses "[f]or Composition X, the Loratadine (80% drug) was added slowly to the mix with stirring. After 5 min. of stirring, the total mix was added to the pan of a three roll coater set (reverse roll coater) at 30 micron coating thickness." Thus the mix is transferred after stirring to the film forming equipment ("the pan of a three roll coater set"). No stirring within the pan is disclosed.
In response to this argument, the examiner maintains that Yang teaches and suggests continuous stirring, this is implied by the teaching of the reference that: continuous stirring,....the composition stirred till deposition...., and the film is formed during processing (¶¶ 0240, 0248). Even if stirring used by the reference to eliminate air, it is taught. The stirring as claimed is performed prior to dividing the mixture into the wells. In any event the ultimate result the prior art achieved is water soluble oral film as claimed and not materially different from the prior art. Combination of the cited references teaches the instantly claimed product produced by the claimed process. Patentability of the product in product by process claim is based on the product since the claimed product and the prior art product are identical.
Further, while the reference exemplify in one of the examples stirring for short period of time, the reference teaches stirring to eliminate air, that expected to be continuous. Applicant is not claiming specific ingredients of the film, and the prior art film comprises the same ingredients applicants used to practice the present invention. Continuous stirring limitation is related to the process of making the orally dissolvable film. The claims’ language does not exclude any steps, e.g., agitation taught by Yang. The ultimate result the prior art achieved is water soluble film as claimed and not materially different from the prior art. Patentability of the product in product by process claim is based on the product since the claimed product and the prior art product are identical. Further, the rejection is not based solely on the casting process taught by Yang, rather the casting process is replaced by depositing process using specific contact angle to achieve the orally soluble film in the wells. Flowing of the suspension into film within 20 seconds is achieved by the composition of the deposited film. Yang teaches film composition comprising the ingredients that applicants used to practice the present invention, and combination of Yang with Myers teaches the claimed contact angle. It is expected from the combination of the cited references to achieve composition having viscosity that flow into film within 20 seconds as claimed.
Applicants disagree with the examiner’s position regarding "the present claim is directed to product by process claims, and product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps", and argue that, as evidenced by the Declaration of Dr. Yang Under 37 C.F.R. $1.132 submitted April 20, 2023, in U.S. application SN 16/703,992, the structure implied by the recited method steps is not obvious from the proposed combination of the cited references. While the Yang Declaration was submitted in connection with another application having different claims, the opinions and reasoning of Dr. Yang relating to the cited references apply to the present rejections. As Dr. Yang notes in the Declaration describes the possibility of dividing the compositions of A-I into individual wells. The suitability of compositions of A-I for casting requires a high viscosity formulation; otherwise, the film formulation will flow too readily, making it impossible to control the thickness of the wet film web prior to drying. Such high viscosity formulations will not be suitable for flowing into a film in a well as set forth in claim 1. Rather such film compositions require a mechanical spreading process like casting to form a film. Dr. Yang opines: “It is my professional opinion that one of ordinary skill would be able to distinguish a film cast in a well by Yang (Examples M-O), from a film made by the Fuisz Claim 2 method. The difference in film formation will be manifest even after the film is dry. In the case of the Fuisz Claim 2 film, you will see the interaction of the liquid film forming composition with the sides of well in the dried film (such films will tend to have edges that curve up with the well). In contrast, a Yang film of Examples M-O cast in a well will show the uniform upper topography of the film that is the signature of the coating apparatus.”
In response to this argument and to Dr. Yang opinion in the declaration, applicant’s attention is directed to the present claims that recite depositing an emulsion of active agent and film forming agent in wells, as instantly claimed. Further, applicants do not claim any specific viscosity of the deposited emulsion to compare with the prior art. Yang clearly teach mixing the ingredients of the film forming agent then dividing them among individual wells, as applicants had done. Yang teaches and suggests continuous stirring, this is implied by the reference that teaches continuous stirring to eliminate air, ....the composition stirred till deposition...., and the film is formed during processing (¶¶ 0240, 0248). The stirring as claimed is performed prior to dividing the mixture into the wells. Myers teaches in the process of making the film and during depositing the film, it is important to achieve a balance between adhesion and cohesion by achieving contact angle less than 90 degrees, since contact angles greater than 90 degrees indicate no or low "wetting" of deposition surface. In any event the ultimate result the prior art achieved is water soluble oral film as claimed and not materially different from the prior art. Combination of he cited references teaches the instantly claimed product produced by the claimed process. Although patentability of the product in product by process claim is based on the product since the claimed product and the prior art product are identical, however, the claimed steps of the claimed product by process are taught and suggested by combination of the cited references. The rationale to modify the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art and the reason to modify the reference may often suggest what the applicant has done.
Applicants argue that Dr. Yang explains the process described in paragraph [0248] of Yang., "[a]fter 5 min. of stirring, the total mix was added to the pan of a three roll coater set (reverse roll coater) at 30 micron coating thickness." As noted by Dr. Yang, "Yang does not teach or suggest that the coating solution in the pan is agitated." Dr. Yang goes on to explain the differences between the present invention and the process of Yang et al., and explains why one of ordinary skill in the art would not understand Yang et al. to teach or suggest continuous stirring as set forth in applicant's claim 2. Dr. Yang explains why "Myers does not disclose wells, flowing compositions, and teaches away from a contact angle with the well of less than 90 degrees." Dr. Yang opines: “With respect to contact angle, Myers teaches that "optimal wetting between the liquid and the substrate" at "about a 90 degree contact angle" (Myers para 136). One of ordinary skill in the art would understand that Fuisz Claim 2 requires a contact angle of less than 90 degrees for a composition that flows in a film in the well. In contrast, Myers does not see flow as desirable at all, rather Myers simply wants to mimic the films with flat edges achieved by coating a continuous web and cutting it into individual pieces. Myers wants his film to stay the shape when he extrudes it onto the substrate.”
In response to this argument, it is argued that while the reference exemplify in
one of the examples stirring for short period of time, the reference teaches stirring to
eliminate air, that expected to be continuous. Applicant is not claiming specific ingredients of the film nor describe the film in terms of its edges and other characteristic. The prior art film comprises the same ingredients applicants used to practice the present invention. The ultimate result the prior art achieved is water soluble film as claimed and not materially different from the prior art. Furter, the rejection is not based solely on the casting process taught by Yang, rather the casting process is replaced by depositing process using specific contact angle to achieve the orally soluble film in the wells. Flowing of the suspension into film within 20 seconds is achieved by the composition of the deposited film. Yang teaches film composition comprising the ingredients that applicants used to practice the present invention, and combination of Yang with Myers teaches the claimed contact angle. It is expected from the combination of the cited references to achieve composition having viscosity that flow into film within 20 seconds as claimed.
Applicants argue that the premise in the office action allegedly supporting the conclusion of obviousness, i.e., regarding Yang disclosing the method steps recited in claim 1 is incorrect. For these reasons, the proposed combination of Yang and Meyers does not render obvious the claimed an oral soluble film.
In response to this argument, it is argued that Myers is relied upon for solely
showing that in the process of making the film and during depositing the film, it is
important to achieve a balance between adhesion and cohesion by achieving contact
angle less than 90 degrees, since contact angles greater than 90 degrees indicate no or
low "wetting" of deposition surface. In any event the ultimate result the prior art achieved is water soluble film as claimed and not materially different from the prior art. Myers reference satisfies the purpose for which it was applied. Again the process of making the claimed oral soluble film and the conditions of the claimed process do not impart patentability to the instant product claims. In response to this argument, applicants attention is directed to the scope of the present claims that are directed to a product, and all the elements of the claimed product are taught by the combination of Yang and Myers as set forth in this office action. The process of making the product does not impart patentability to the claims. In any event, the claimed method is suggested by the combination of the cited references, as set forth in this office action.
The obviousness does not require absolute predictability of success all that is required is a reasonable expectation of success. See In re Kubin, 561 F.3d at 1360. The Court has held that "the test of obviousness is not express suggestion of the claimed invention in any or all of the references but rather what the references taken collectively would suggest to those of ordinary skill in the art presumed to be familiar with them." See In re Rosselet, 146 USPQ 183, 186 (CCPA 1965). "There is no requirement (under 35 USC 103(a)) that the prior art contain an express suggestion to combine known elements to achieve the claimed invention. Rather, the suggestion to combine may come from the prior art, as filtered through the knowledge of one skilled in the art." Motorola, Inc. v. Interdigital Tech. Corp., 43 USPQ2d 1481, 1489 (Fed. Cir.1997). An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of a case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. See KSR Int'l Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) ("The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.").
Applicants argue that Bunick is directed to the manufacture of orally disintegrating tablets, not films. Moreover, Bunick is not using film forming compositions, but rather, using powder compositions (paragraph [0011]). The absence of mechanical intervention (see page 19 of the office action) in the powder compositions of Bunick has no relevance in the context of the formation of a film. Therefore, Bunick does not remedy any of the deficiencies of the proposed combination of Yang and Meyers.
In response to applicant’s argument, it is argued that Bunick is relied upon for teaching suitability of the contact angle to form orally disintegrating dosage form without use any compression force. It should be noted that the motivation to combine references can be different from the ones set forth by Applicant. That is, as long as motivation exists to combine the elements, the problem to be solved does not have to involve the same reason. The examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so
found either in the references themselves or in the knowledge generally available to one
of ordinary skill in the art. See /n re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir.
1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR
International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./
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