SUPPOSITORY CAPSULE

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 . Status of the Claims Claims 1-5, 10, 13-16, 18, 22-25, 41, 45-47, 51-53, and 55 are pending. Claims 47 and 51-53 are withdrawn from consideration as directed to non-elected inventions. Claims 1-5, 10, 13-16, 18, 22-25, 41, 45, 46, and 55 are rejected as set forth in greater detail below. Claim Interpretation Applicants claims are directed to compositions which comprise a “suppository base,” which applicants define as “a suppository delivery system material,” (Specification [0051]), having a horizontal dimension greater than a vertical dimension being provided in shapes provide as a Markush-type listing of alternative solid forms, with a proximal horizontal portion adapted for insertion into a body cavity, and a distal horizontal portion having two indentations, each being on the opposite side of the distal end from the other, with the indentations being concave and lateral relative to the horizontal axis, and wherein the proximal and distal portions of the composition are separated by a portion wider than the proximal and distal portions of the composition. Dependent claims require the inclusion of an active agent, and further specify where in the composition the active is to be found. Claim 9 recites a variety of alternative manifestations of the shape of the composition, with Claim 10 placing limitations on the shape of the indentation. Claims 13-15 require the composition be provided as a core-shell configuration with additional limitations on the location of the active or the base. Claims 16 and 18 limit the identity of the shell or base, respectively. Claims 22-24 place functional limitations on the composition in terms of the location of use, or of the therapeutic effect the active contained within the composition is to manifest. Claim 25 narrows the identity of the active to be included in the composition, and Claim 41 requires the inclusion of a plasticizer in the shell component. Claims 45 and 46 place concentration limitations on components of the shell portion of the composition. Claim 55 specify that the indentations are identical and on opposing lateral sides of the distal end. 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 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 1-5, 10, 13-15, 22-25, and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Beckett (U.S. PGPub. 2002/0048601) in view of Barnscheid (U.S. 10,080,721), and Haeri (U.S. PGPub. 2018/0338779). Beckett describes suppositories containing a suppository base provided with a horizontal length greater than a vertical length possessing an indentation at one end, shaped for insertion into the rectum or vagina, provided in the form of an indented bullet or torpedo. See Fig.1, 2, 5; [0278; 0283-84; 0305-14]. Beckett, in addition to describing the shapes of the suppositories and their use in rectal or vaginal application, describes additional embodiments of the suppositories of the disclosure. Incorporation of an active agent into these suppositories is described by Beckett. [0030]. Non-limiting examples of the active agent include analgesics and anti-inflammatory agents. [0110]. Beckett indicates these agents may be provided in controlled release forms, such as liposomes and nanoparticles encapsulating the agent which are suspended in the suppository, meaning that the areas of the distal end outside of the particulate carriers would necessarily not contain active agent, addressing the limitations of Claim 5. [0127]. Beckett indicates that these agents may be designed to provide either local or systemic effect, addressing the limitations of Claims 23 and 24. [0138]. Additional embodiments which possess a coating, representing the “core and shell” structure of Claim 13 are also described. [0081-82]. Beckett indicates that these core/shell embodiments may be represented by a central core containing a first composition and a surrounding part around the core comprising a second composition, where either the core or the shell may contain the active agent to be delivered, addressing the limitations of Claims 14 and 15. [0191-93]. The specific combination of features claimed is taught or suggested within the breadth of the disclosure of the reference, but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any motivation to select this specific configuration of a suppository in the shape of a bullet or torpedo possessing multiple concave indentations in the distal end and a configuration suited for insertion into the vagina or rectum having a base surrounded by a shell, with an active agent distributed throughout, or only in designated portions, of the base, to provide local or systemic therapeutic effect, anticipation cannot be found. That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. Consistent with this reasoning, it would have been prima facie obvious to have selected various combinations of a suppository in the shape of a bullet or torpedo possessing concave indentations in the distal end and a configuration suited for insertion into the vagina or rectum having a base surrounded by a shell, with an active agent distributed throughout, or only in designated portions, of the base, to provide local or systemic therapeutic effect from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.” Despite the breadth of teachings, Beckett does not describe the suppository as an indented bullet, oval, ovoid, or teardrop having two indentations on opposing sides of the distal end of the suppository, nor is a device having the proximal and distal portions separated by a boundary portion being wider than either the proximal or distal portions. This is addressed by the teachings of Barnscheid, which describes oblong pharmaceutical compositions suitable for use as rectal or vaginal drug delivery devices. (Abs.; Col.23, L.1-6). Barnscheid indicates that these devices preferably are provided in the form of an oblong tablet having indentations (also referred to as “recesses,” “cavities,” and “bulges”) on opposing sides of the device, which serves to provide for improved release profiles of agents contained therein. (Col.10, L.36-43; Cool.12, L.25-28; Col.13, L.31-36; Col.14, L.13-15). Barnscheid describes embodiments where these ovoid bulges extend perpendicularly from the base of the tablet along the longitudinal axis of the device on two opposite sides of the device. (Col.13, L.13-17; 43-45; Col.14, L.6-12, 29-32, 47-55). Haeri also refers to devices for insertion into and retention within the vagina, where the cross section of the device varies along the length of the device, specifying that the middle section has a cross section larger than either the distal or proximal ends of the device. [0023], “Fig.6.” It therefore would have been prima facie obvious to one of ordinary skill in the art to have provided the suppository of Beckett with a shape such that the middle section has a cross section larger than either the distal or proximal ends of the device, possessing identical oval indentations on opposite sides of the distal end of the device as is suggested by the teachings of Barnscheid. This is not only because Barnscheid also teaches such symmetries are useful in providing tablet-shaped devices for rectal or vaginal use, implying a suppository as is taught by Beckett, but also because Barnscheid indicates that an advantage, namely the control of release profile, would be obtained by such an adoption. See In re Sernaker, 702 F.2d 989, 994-95 (Fed. Cir. 1983) (“The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination.”). Providing such a device with a middle section wider than either the proximal or distal ends taught by Haeri simply represents the use of a shape known to be useful in the manufacture of devices for insertion into and retention within these orifices. See KSR, supra. While perforated indentations are not specifically identified, applicants are reminded that such configurations are a matter of choice which a person of ordinary skill int eh art would have found obvious absent persuasive evidence that the particular configuration was significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Claims 1-5, 10, 13-16, 18, 22-25, 41, 45, 46, and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Beckett, Barnscheid, and Haeri as applied to Claims 1-5, 10, 13-15, 22-25, and 55, above, and further in view of Hanke (GB1431092), and Rhodehamel (U.S. 1,366,941). Beckett, Barnscheid, and Haeri, discussed in greater detail above, suggests a suppository in the shape of a bullet or torpedo possessing multiple concave indentations on opposite sides of the distal end and a configuration suited for insertion into the vagina or rectum having a base surrounded by a shell, with an active agent distributed throughout, or only in designated portions, of the base, to provide local or systemic therapeutic effect. Beckett and Barnscheid do not, however, specify that the core should contain any of the components of Claim 18, or the shell any of the components of Claims 16 or 45 or the plasticizer of Claims 41 or 46. However, Hanke indicates that suppositories have long been formulated using cocoa butter of Claim 18 as the suppository base. Pg.1, L.72-73. Rhodehamel adds to this knowledge by indicating that suppository bases containing fatty materials are made more suitable for handling and better able to retain medicinal substances within the suppository by providing the solid suppositories with a coating of gelatin, either alone or more favorably in combination with, for example, glycerin to make the coating tough and pliable. L.13-21; 41-50; 80-86. The examiner notes that not only does Rhodehamel indicate the components added to the gelatin shell coating impart pliability to the composition, suggesting a plasticizing effect, but Rhodehamel specifies that the glycerin which applicants exemplify as a representative plasticizer is recited as an exemplary additive. See Specification [00116]. While the concentrations of gelatin and plasticizer are not specified by Rhodehamel, applicants are reminded that Rhodehamel describes each of the gelatin and glycerin as providing encapsulating and plasticizing properties to the compositions into which they are incorporated. On this basis, a person of ordinary skill in the art would reasonably conclude that the amounts of each are result-effective variables that achieve the results each of the components referred to provide. As such, it would have been routine to optimize the amounts of these components within the total composition suggested by Rhodehamel. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.). It would have been prima facie obvious to have used cocoa butter suggested by Hanke as the suppository base to include the active agents and the physical parameters of the suppositories of Beckett and Barnscheid, then coated such a suppository with a combination of gelatin and glycerin to provide a fatty containing suppository configured to be more easily handled and used per the teachings of Rhodehamel. One of ordinary skill in the art would be motivated to do so owing to the art-known utility of each of cocoa butter as a suppository base, and the combination of gelatin and glycerin as fatty suppository base coatings. The claimed arrangement of art-known elements appears little more than the predictable use of prior art elements according to their established functions, and obvious thereby. See KSR, supra. Response to Arguments Applicant's arguments filed 12 August 2026 have been fully considered but they are not persuasive. Applicants again argue that the claims as amended require that “the distal end [of the suppository] has two indentations, each indentation being on opposing sides of the distal end,” that the concave indentations of the Barnscheid example relied on are not localized on one end, but rather extend from the distal end along the vertical axis of the suppository towards the proximal end to provide an “H-shaped” configuration, and that the newly added limitations concerning the configuration of proximal and distal portions separated by a wider boundary area are not taught by the Barnscheid examples. Concerning the latter of these arguments, this newly added limitation has been addressed by the Examiner’s new reliance on the teachings of Haeri as set forth in greater detail above. Applicants arguments concerning the configuration of one of the Barnscheid examples, and in fact one which the Examiner has not specifically relied on in setting forth the prima facie case of obviousness, of incorporating opposing indentations into rectal or vaginal suppositories is unpersuasive. Applicants are reminded that art is art, not only for what it expressly teaches, but also for what it would reasonably suggest to the skilled artisan, including alternative or non-preferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). Barnscheid explicitly establishes that the size and shape of the indentations impacts the rate of release of active agents incorporated into the device (Col.4, L.57-64), and advises that the length of the indentation along the longitudinal length of the device is preferably no longer than one third the length of the dosage form. (Col.14, L.6-12). Choosing to locate such indentations at the distal end of the device from within the teachings of Barnscheid amounts to little more than a particular design choice and would be obvious thereby. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.). Applicants discussion of particular embodiments described by Barnscheid, and in fact attempting to asset that whatever the description of the indentations, these are not disposed “laterally,” is unpersuasive because Barnscheid explicitly establishes that the designation of either the “front” or the “back” of the device “is rather arbitrary.” (Col.14, L.29-36). Indeed, Barnscheid indicates that the “indentations are regularly positioned in the base area of the front and/or the back side of the dosage form,” establishing the intent to, as applicants recite in their claims, have these indentations positions opposite each other near the base, or distal, end of the device. (Col.14,L.54-55). Applicants repeatedly point to what Barnscheid explicitly indicates are optional, preferred, or alternative embodiments as representing absolute requirements the devices described must possess. This is in opposition to the proper flexible and expansive approach to the question of obviousness, not only in terms of articulating a rationale for combining art, but also explicitly as to the consideration of what the prior art, considered as a whole, conveys to the skilled artisan. KSR v. Teleflex, 127 S.Ct. 1727, 1741-42 (2007)( the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ…“[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.”). Applicants are reminded that the reason or motivation to modify a prior art reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention). As such, though the rationale for modifying the shape and placement of concavities along a medical device such as a suppository differs from applicants own justification for having done so, the configuration claimed is nevertheless suggested by the art. Applicants position that there is no reason provided by Barnscheid to place the indentations near the end of the dosage form is contradicted by the teachings of Barnscheid itself, which indicates that the base, or distal per the instant claims, is to bear the indentations recited. This is also bolstered by the teachings of the newly-relied on Haeri reference, which in Fig.6 describes a suppository from not only nearing a wider boundary area between the proximal and distal ends of the device, but also possessing indentations adjacent to the base of the device. As the language concerning the “boundary” region of the device was not previously presented as a claim limitation, the Haeri reference is newly relied upon to augment the teachings of Barnscheid and address this new dimensional limitation. The indentations described by Barnscheid, which are taught as being includable near the base of the device as is required by the claims, augmented by the teachings of Haeri concerning the suppository shape being wider in the boundary region between the proximal and distal ends of the device and which also possesses indentations distal to the boundary region and before a wider base, indeed appears to suggest exactly what applicants claim was well-known as features of suppositories in the prior art. For at least these reasons, applicants arguments are unpersuasive. Conclusion No Claims are allowable. 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 SEAN M BASQUILL whose telephone number is (571)270-5862. 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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. /SEAN M BASQUILL/Primary Examiner, Art Unit 1614