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 .
Formal Matters
Applicant’s response to the election /restriction requirement mailed on 06 February 2026 filed on 02 April 2026 is acknowledged and has been fully considered. Claims 1-30 are pending. Claims 1-30 are under consideration in the instant office action.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The effective filing date of this application is determined to be 27 September 2023, which is the filing date of the foreign application PCTIB2023059640.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 21, 2024 are noted and the submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the examiner has considered the information disclosure statement. A signed copy is attached herein.
Election Restriction
Applicant’s election without traverse of subspecies III (claims 22-30) in the reply filed on 02 April 2026 is acknowledged. Upon further consideration by the Examiner claims 1-12 (subspecies I ) and 13-21 (subspecies II) are hereby rejoined for further examination on the merits given claims 1-21 recite in the body of the claims substantially similar subject matter except differences in concentrations and weight ratios, which are addressed by the rejections under 35 USC 103 set forth below. Election was made without traverse in the reply filed on 02 April 2026.
Objection to the title
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The title of the instant application is “PHARMACEUTICAL COMPOSITION”. The title should be brief but technically accurate and descriptive and should contain fewer than 500 characters. The title does not describe the inventive concept in a way highlighting what are the important components of the composition. The title “PHARMACEUTICAL COMPOSITIONS” can be applicable to any pharmaceutical composition. The essential components of the composition are crucial for the invention and applicant should consider amending the title reflecting those essential ingredients mainly the active agent. The title should to the minimum describe the generic content of the structures. Inasmuch as the words "new," "improved," "improvement of," and "improvement in" are not considered as part of the title of an invention, these words should not be included at the beginning of the title of the invention and will be deleted when the Office enters the title into the Office’s computer records, and when any patent issues. Similarly, the articles "a," "an," and "the" should not be included as the first words of the title of the invention and will be deleted when the Office enters the title into the Office’s computer records, and when any patent issues.
Objection to the claims
Claims 2-12, 14, 17-21, 23, and 26-30 are objected to because of the following informalities: Dependent claims 2-12, 14, 17-21, 23, and 26-30 recite “the formulation”. For clarity and consistency purposes, Applicant should amend the phrase to recite “the pharmaceutical formulation”. Appropriate correction is required.
Claims 3, 11, 20, and 29 are objected to because of the following informalities: claims 3, 11, 20, and 29 recite “40 deg C”. Applicant should amend the recitations to “40 ºC”. Appropriate correction is required.
Claims 19 and 28 are objected to because of the following informalities: claims 19 and 28 recite “30º C”. Applicant should amend the recitations to “30 ºC”. Appropriate correction is required.
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 1-30 are rejected under 35 U.S.C. 103 as being unpatentable over Shen et al. (US 2024/0180903, filed on March 20, 2023, IDS reference 09/25/2025) in view of Akhaven et al. (US2023/0045509, IDS reference 09/25/2025).
Applicants’ claims
Applicant claims a pharmaceutical formulation comprising cabotegravir and other ingredients.
Determination of the Scope and Content of the Prior Art
(MPEP 2141.01)
Shen et al. teach an injectable pharmaceutical composition, a preparation method therefor and use thereof are provided. The pharmaceutical composition contains an active ingredient and a pharmaceutically acceptable auxiliary material. The active ingredient comprises cabotegravir or a pharmaceutically acceptable salt thereof, and the auxiliary material comprises a surfactant and a suspending agent. The pharmaceutical composition and a formulation thereof are used for treating and preventing HIV infection, have good stability, and are suitable for industrial production (see abstract) Shen et al. teach on paragraph 0003 cabotegravir (formula I) is the 2nd generation integrase strand transfer inhibitor (INSTI) produced by ViiV Healthcare, the special pharmaceutical properties of which make it suitable for formulating into a long-acting sustained-release formulation.
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A pharmaceutical composition, wherein the pharmaceutical composition comprises an active ingredient and a pharmaceutically acceptable auxiliary material; the active ingredient comprises cabotegravir or a pharmaceutically acceptable salt thereof, and the auxiliary material comprises a surfactant and a suspending agent (see claim 1). The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition further comprises a lyophilization excipient (see claim 2). The pharmaceutical composition according to claim 2, wherein the suspending agent is a cellulose suspending agent, for example, selected from at least one of carboxymethylcellulose and a sodium salt thereof, hydroxypropylcellulose and a sodium salt thereof, hydroxypropyl methylcellulose and a sodium salt thereof, methylcellulose and a sodium salt thereof, hydroxyethylcellulose and a sodium salt thereof, sodium hyaluronate, and polyvinylpyrrolidone; and/or the surfactant is selected from at least one of polysorbate or a derivative thereof, and polyethylene glycol stearate or a derivative thereof; for example, the polyethylene glycol stearate or the derivative thereof is selected from polyethylene glycol 15-hydroxystearate, and the polysorbate or the derivative thereof is selected from polysorbate-80; and/or the lyophilization excipient is selected from at least one of mannitol, trehalose, and glucose; preferably, the auxiliary material further comprises an isoosmotic adjusting agent. The pharmaceutical composition according to claim 2, wherein the surfactant and cabotegravir or the pharmaceutically acceptable salt thereof are in a weight ratio selected from 1:(0.01-100); and/or the suspending agent and cabotegravir or the pharmaceutically acceptable salt thereof are in a weight ratio selected from 1:(0.01-100); and/or the lyophilization excipient and cabotegravir or the pharmaceutically acceptable salt thereof are in a weight ratio selected from 1:(0.01-100) (see claim 4). A pharmaceutical formulation, wherein the pharmaceutical formulation comprises the pharmaceutical composition according to claim 1; preferably, the pharmaceutical formulation comprises the pharmaceutical composition and a dispersing solvent; preferably, the pharmaceutical formulation is prepared by suspending the pharmaceutical composition in the dispersing solvent, preferably by suspending an injectable lyophilized powder in the dispersing solvent; preferably, the dispersing solvent is water; and preferably, cabotegravir or the pharmaceutically acceptable salt thereof has a concentration selected from 0.01-800 mg/mL (see claim 7).
With respect to the particle size distribution of the drug particles and storage stability recitations of claims 3, 7, 11, 20, and 29, Shen et al. teach the pharmaceutical formulation according to claim 7, wherein in the pharmaceutical formulation, particles of the pharmaceutical composition in the dispersing solvent have particle size distributions as follows: D10 is in the range of about 0.5 μm to about 10 μm, D50 is in the range of about 2 μm to about 25 μm, and a particle size D90 is in the range of about 5 μm to about 50 μm (see claim 8). In some embodiments, the D50 has a change range of less than about 2 μm, such as a change range of 0.1, 0.3, 0.5, 0.7, 1.0, 1.2, 1.5, or 1.8 μm, under a storage condition of room temperature or high temperature (50-70° C., such as 60 °C); the D90 has a change range of less than about 5 μm, such as a change range of 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, or 4.5 μm. In some embodiments, all of the D10, D50 and D90 have a change range of less than 1 μm, such as independently, a change range of 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, or 0.9 μm, under an accelerated experiment condition of room temperature or high temperature (50-70 °C, such as 60 °C) (paragraph 0028). Further, the storage time may be 1 month, 2 months, 3 months or more (paragraph 0029). In one embodiment, the D50 of the particles has a change range of less than about 2 μm, such as a change range of 0.1, 0.3, 0.5, 0.7, 1.0, 1.2, 1.5, or 1.8 μm during storage at room temperature for 2 months; the D90 has a change range of less than about 5 μm, such as a change range of 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, or 4.5 μm (paragraph 0030). According to an embodiment of the present disclosure, the particle size D50 of the particles is less than 30 μm, preferably less than 20 μm, and more preferably less than 5 μm. For example, the particle size D50 is 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, or 25 μm (paragraph 0031). The term “particularly stable” related to the particle size means that D10 is in the range of about 0.5 μm to about 10 μm, D50 is in the range of about 2 μm to about 25 μm, and D90 is in the range of about 5 μm to about 50 μm; meanwhile, all of the D10, D50 and D90 have a change range of less than 1 μm (paragraph 0054). The present disclosure provides an injectable pharmaceutical composition/lyophilized formulation containing cabotegravir, which can be stored at room temperature and has long storage period. After reconstituting the lyophilized powder formulation, the particle size of the obtained cabotegravir suspension injection always remains stable, even to a particularly stable degree (paragraph 0062). Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979) (Claims were directed to grooved carbon disc brakes wherein the grooves were provided to vent steam or vapor during a braking action. A prior art reference taught noncarbon disc brakes which were grooved for the purpose of cooling the faces of the braking members and eliminating dust. The court held the prior art references when combined would overcome the problems of dust and overheating solved by the prior art and would inherently overcome the steam or vapor cause of the problem relied upon for patentability by applicants. Granting a patent on the discovery of an unknown but inherent function (here venting steam or vapor) "would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art." 596 F.2d at 1022, 201 USPQ at 661.); In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991) (Appellant argued that the presence of DEHP as the plasticizer in a blood collection bag unexpectedly suppressed hemolysis and therefore rebutted any prima facie showing of obviousness. However, the closest prior art utilizing a DEHP plasticized blood collection bag inherently achieved same result, although this fact was unknown in the prior art.). "The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").
Shen et al. teach according to an embodiment of the present disclosure, the unit dosage form of the pharmaceutical formulation comprises 20-60 mg, such as 30 mg. 40 mg, or 50 mg of cabotegravir, and the content calculated by cabotegravir is a therapeutically effective amount (paragraph 0033). According to an embodiment of the present disclosure, cabotegravir or the pharmaceutically acceptable salt thereof has a concentration selected from 0.01-800 mg/mL, such as 10-400 mg/mL, preferably 20-400 mg/mL, and more preferably 150-200 mg/mL (paragraph 0026). Shen et al. teach Cabotegravir Suspension Injections (Lyophilized Powder) I and II and Preparation Thereof and in Examples 1 and 2 respectively as follows:
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Preparation method: cabotegravir was dissolved with NMP of 15 times the weight of cabotegravir at 60-70° C. The agent liquid was added to water of 10 times the volume of NMP at a uniform speed within 10 min under the stirring condition of 600 rpm to obtain cabotegravir by precipitation. The mixture solution was filtered. The precipitate was washed with water, and then homogeneously mixed with auxiliary materials in Table 1 and ultrapure water. The mixture was lyophilized to obtain the cabotegravir suspension injection (lyophilized powder) I. 2 mL of water for injection was added for reconstitution, then the particle sizes were detected to be D10 of 2.00 μm, D50 of 8.25 μm, and D90 of 18.99 μm (paragraph 0072).
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Preparation method: cabotegravir was dissolved with DMSO of 15 times the weight of cabotegravir at 60-70° ° C. The agent liquid was added to water of 10 times the volume of DMSO (ice water bath, controlling the crystallization temperature below 15° C.) within 10 min under the shearing condition of 5000 rpm to obtain cabotegravir by precipitation. The mixture solution was filtered. The precipitate was washed with water, and then homogeneously mixed with auxiliary materials in Table 2 and ultrapure water. The mixture was lyophilized to obtain the cabotegravir suspension injection (lyophilized powder) II. 2 mL of water for injection was added for reconstitution, then the particle sizes were detected to be D10 of 1.43 μm, D50 of 5.33 μm, and D90 of 12.89 μm (paragraph 0073). One of ordinary skill in the art for example, from Table 2 assuming the total volume is 2 mL can calculate 400/2 (200 mg/mL of cabotegravir), 6/2 (3 mg/mL of polysorbate 80), 16/2 (8 mg/mL of sodium carboxymethylcellulose), and 80/2 (40 mg/mL of mannitol). The concentrations of active agent, polysorbate 80, sodium carboxymethylcellulose, and mannitol; the X50 (D50) and the X90 (D90) particle size distributions; and the ratios of each of the ingredients to the active agent clearly overlap in scope with the claimed ranges, respectively. The concentrations of active agent, polysorbate 80, sodium carboxymethylcellulose, and mannitol; the X50 (D50) and the X90 (D90) particle size distributions; and the ratios of each of the ingredients to the active agent are result effective parameters and are within the purview of one of ordinary skill in the art to optimize. Furthermore, in the case where the amount of ingredients, particle sizes, concentrations of ingredients, weight ratios etc., "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) Furthermore, differences in concentration or size will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1955).
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP 2141.02)
Shen et al. do not specifically teach wherein the formulation has a pH of about 4 to about 8. These deficiencies are cured by the teachings of Akhaven et al.
Akhaven et al. teach a pharmaceutical composition comprising cabotegravir or a pharmaceutically acceptable salt thereof, polyethylene glycol and poloxamer useful as a long acting HIV treatment (see abstract). In an embodiment the composition of the invention further comprises a tonicity adjuster. The tonicity adjuster may be selected from any suitable tonicity adjuster. In an embodiment of the invention, the tonicity adjuster adjusts tonicity to be within 250 to 350 mOsmol/kg. In another embodiment the tonicity adjuster adjusts tonicity to be within 285 to 310 mOsmol/kg. In an embodiment mannitol is used as the tonicity adjuster. In an embodiment of the invention, the mannitol adjusts tonicity to be within 250 to 350 mOsmol/kg. In another embodiment the mannitol adjusts tonicity to be within 285 to 310 mOsmol/kg. In an embodiment of the invention mannitol is present in the pharmaceutical composition at a concentration of 15 to 30 mg/mL (paragraph 0046). The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises a cabotegravir concentration of 350 to 600 mg/mL (see claim 10). In an embodiment the composition of the invention has a pH of about 4 or greater. A pH of about 4 or more reduces pain to the patient if the composition is administered via injection (paragraph 0047).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP 2142-2143)
It would have been prima facie obvious to a person of ordinary skill in the art at the time the present invention was filed to modify the teachings of Shen et al. formulating the composition wherein the formulation has a pH of about 4 to about 8 because Akhaven et al. teach a pharmaceutical composition comprising cabotegravir or a pharmaceutically acceptable salt thereof, polyethylene glycol and poloxamer useful as a long acting HIV treatment (see abstract). In an embodiment the composition of the invention further comprises a tonicity adjuster. The tonicity adjuster may be selected from any suitable tonicity adjuster. In an embodiment of the invention, the tonicity adjuster adjusts tonicity to be within 250 to 350 mOsmol/kg. In another embodiment the tonicity adjuster adjusts tonicity to be within 285 to 310 mOsmol/kg. In an embodiment mannitol is used as the tonicity adjuster. In an embodiment of the invention, the mannitol adjusts tonicity to be within 250 to 350 mOsmol/kg. In another embodiment the mannitol adjusts tonicity to be within 285 to 310 mOsmol/kg. In an embodiment of the invention mannitol is present in the pharmaceutical composition at a concentration of 15 to 30 mg/mL (paragraph 0046). The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises a cabotegravir concentration of 350 to 600 mg/mL (see claim 10). One of ordinary skill in the art would have been motivated to do so because Akhaven et al. teach that in an embodiment the composition of the invention has a pH of about 4 or greater. A pH of about 4 or more reduces pain to the patient if the composition is administered via injection (paragraph 0047). Furthermore, in the case where the pH of the composition "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) Furthermore, differences in concentration or pH will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1955). One of ordinary skill in the art would have had a reasonable chance of success in combining the teachings of Shen et al. and Akhaven et al. because both references teach injectable compositions containing cabotegravir.
With respect to the particle size distribution of the drug particles and storage stability recitations of claims 3, 7, 11, 20, and 29, Shen et al. teach the pharmaceutical formulation according to claim 7, wherein in the pharmaceutical formulation, particles of the pharmaceutical composition in the dispersing solvent have particle size distributions as follows: D10 is in the range of about 0.5 μm to about 10 μm, D50 is in the range of about 2 μm to about 25 μm, and a particle size D90 is in the range of about 5 μm to about 50 μm (see claim 8). In some embodiments, the D50 has a change range of less than about 2 μm, such as a change range of 0.1, 0.3, 0.5, 0.7, 1.0, 1.2, 1.5, or 1.8 μm, under a storage condition of room temperature or high temperature (50-70° C., such as 60 °C); the D90 has a change range of less than about 5 μm, such as a change range of 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, or 4.5 μm. In some embodiments, all of the D10, D50 and D90 have a change range of less than 1 μm, such as independently, a change range of 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, or 0.9 μm, under an accelerated experiment condition of room temperature or high temperature (50-70 °C, such as 60 °C) (paragraph 0028). Further, the storage time may be 1 month, 2 months, 3 months or more (paragraph 0029). In one embodiment, the D50 of the particles has a change range of less than about 2 μm, such as a change range of 0.1, 0.3, 0.5, 0.7, 1.0, 1.2, 1.5, or 1.8 μm during storage at room temperature for 2 months; the D90 has a change range of less than about 5 μm, such as a change range of 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, or 4.5 μm (paragraph 0030). According to an embodiment of the present disclosure, the particle size D50 of the particles is less than 30 μm, preferably less than 20 μm, and more preferably less than 5 μm. For example, the particle size D50 is 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, or 25 μm (paragraph 0031). The term “particularly stable” related to the particle size means that D10 is in the range of about 0.5 μm to about 10 μm, D50 is in the range of about 2 μm to about 25 μm, and D90 is in the range of about 5 μm to about 50 μm; meanwhile, all of the D10, D50 and D90 have a change range of less than 1 μm (paragraph 0054). The present disclosure provides an injectable pharmaceutical composition/lyophilized formulation containing cabotegravir, which can be stored at room temperature and has long storage period. After reconstituting the lyophilized powder formulation, the particle size of the obtained cabotegravir suspension injection always remains stable, even to a particularly stable degree (paragraph 0062). Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979) (Claims were directed to grooved carbon disc brakes wherein the grooves were provided to vent steam or vapor during a braking action. A prior art reference taught noncarbon disc brakes which were grooved for the purpose of cooling the faces of the braking members and eliminating dust. The court held the prior art references when combined would overcome the problems of dust and overheating solved by the prior art and would inherently overcome the steam or vapor cause of the problem relied upon for patentability by applicants. Granting a patent on the discovery of an unknown but inherent function (here venting steam or vapor) "would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art." 596 F.2d at 1022, 201 USPQ at 661.); In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991) (Appellant argued that the presence of DEHP as the plasticizer in a blood collection bag unexpectedly suppressed hemolysis and therefore rebutted any prima facie showing of obviousness. However, the closest prior art utilizing a DEHP plasticized blood collection bag inherently achieved same result, although this fact was unknown in the prior art.). "The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").
The combination teaching of Shen et al. and Akhaven et al. as described above clearly teach a substantially identical or similar product. Therefore, any functional or structural properties that are recited in claims 3-4, 7-8, 11-12, 15, 19-20, 24, and 28-29 would necessarily be present. "In relying upon the theory of inherency, the examiner must provide a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art." Ex parte Levy, 17 USPQ2d 1461, 1464 (Bd. Pat. App. & Inter. 1990) (emphasis in original). In PAR Pharmaceutical, Inc. v. TWI Pharmaceuticals, Inc., 773 F.3d 1186, 112 USPQ2d 1945 (Fed. Cir. 2014), the Federal Circuit remanded a decision to the district court because the record did not present sufficient evidence to prove inherency in the context of obviousness. The district court concluded the pharmacokinetic parameters of a claim are inherent properties of the obvious formulation. The Federal Circuit stated that while "inherency may support a missing claim limitation in an obviousness analysis", "the use of inherency, a doctrine originally rooted in anticipation, must be carefully circumscribed in the context of obviousness." Id. at 1194-95, 112 USPQ2d at 1952. "[I]n order to rely on inherency to establish the existence of a claim limitation in the prior art in an obviousness analysis – the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art." Id. at 1195-96, 112 USPQ2d at 1952. But see, Persion Pharms. LLC v. Alvogen Malta Operations LTD., 945 F.3d 1184, 1191, 2019 USPQ2d 494084 (Fed. Cir. 2019), where the court stated that a proper finding of inherency does not require that all limitations are taught in a single reference, and that inherency may meet a missing claim limitation when the limitation is "the natural result of the combination of prior art elements." (emphasis in original). The court found that pharmacokinetic limitations of the asserted claims were inherently met by combining prior art references because the limitations were necessarily present in the prior art combination. Id. See also Hospira, Inc. v. Fresenius Kabi USA, LLC, 946 F.3d 1322, 1329-32, 2020 USPQ2d 6227 (Fed. Cir. 2020).
The examiner also carefully reviewed Applicant’s disclosure for any comparison data demonstrating unexpected or surprising results based on types of ingredients, concentrations of ingredients, particle size distributions of the active agent etc. No comparison data was found in the original disclosure. All data is drawn to Applicant’s own compositions. The examiner reminds Applicant that PTO does not conduct laboratory based experiments. Once a prima facie case is made against the claims, it is Applicant’s burden to come on the record and show through comparison experimental data or persuasive arguments how their invention is different. The examiner further reminds Applicant if in the future such comparative experimental data is provided, Applicant relying upon comparative showing to rebut prima facie case must compare his claimed invention with closest prior art In re Holladay, 584 F.2d 384, 199 USPQ 516 (CCPA 1978); Ex parte Humber, 217 USPQ 265 (Bd. App. 1961). Furthermore, whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). If applicant provides unexpected results with a comparison data the claims must be commensurate in scope with the data in terms of types and amounts of ingredients and specific steps.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that "just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel." Id. See also MPEP § 2112.01 with regard to inherency and product-by-process claims and MPEP § 2141.02 with regard to inherency and rejections under 35 U.S.C. 103.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIGABU KASSA whose telephone number is (571)270-5867. The examiner can normally be reached 8 AM-5 PM.
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/TIGABU KASSA/Primary Examiner, Art Unit 1619
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