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 .
DETAILED ACTION
The preliminary amendment filed 07/24/2026, cancelled claims 1-16 and added claims 17-36.
Claims 17-36 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17/274432 and Foreign Priority Application IN201821034590 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
-In claim 30, the recitation “wherein the colloidal silica is present in an amount effective to suspend lenalidomide in the medium chain triglyceride” is not supported by Application No. 17/274432 or Foreign Priority Application IN201821034590.
While ‘432 and ‘590 teach a) the suspending agent comprising about 0.1-20% w/w of the composition ([0013], [0048] of ‘432; [12], [47] of ‘590), and b) the suspending agent comprising about 0.01%w/w to about 95% w/w of the composition ([0047]; [46] of ‘590), this does not provide implicit or explicit support for wherein the colloidal silica is present in an amount effect to suspend lenalidomide in the medium chain triglyceride”
As such, claims 30-31 and 33 are afforded an effective filing date of the instantly claimed invention, 01/17/2025.
-In claim 34, the following recitations are not supported by Application No. 17/274432 or Foreign Priority Application IN201821034590:
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While ‘432 and ‘590 teach suspending agents as components of their compositions and teach other components in their compositions, they do not provide explicit or implicit support for the broad recitations:
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As such, claims 34-36 are afforded an effective filing date of the instantly claimed invention, 01/17/2025.
Abstract
The abstract of the disclosure is objected to. A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains.
The instant claims are directed toward lenalidomide non-aqueous oral suspensions. However, the abstract describes a composition comprising temozolomide, which is not “a concise statement of the technical disclosure of the patent” and which does not “include that which is new in the art to which the invention pertains.”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 19 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
-Claim 19 contains the trademarks/trade names MIGLYOL and Kollisolv MCT 70. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name.
In the present case, the trademark/trade name is used to identify/describe medium chain triglycerides and fatty acid esters derived from coconut and palm kernel oils and medium chain triglycerides of decanoyl and octanoyl, respectively; accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 25 and 28 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
-Claim 25 recites “wherein the colloidal silica comprises colloidal silicon dioxide.” However, colloidal silica and colloidal silicon dioxide are synonyms. As such, claim 25 does not further limit claim 24, from which it depends.
-Claim 28 recites “wherein the suspension does not include water.” However, claim 17, from which claim 28 depends, recites the suspension as “non-aqueous,” which means that the suspension does not contain water. As such, claim 28 does not further limit claim 17.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 34-36 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO2020/053665 to Patel (published 03/19/2020, PTO-892).
Regarding claims 34-36, Patel teaches liquid oral suspensions and exemplifies the following suspension:
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(pgs. 18-19; pg. 21, claim 1; abstract).
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 17-36 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (Clin Pharmacokinet, published 2017, IDS of 01/17/2026) in view of US20130115294 to First (published 2013, IDS of 01/17/2025), and further in view of Song (Crystal Growth & Design, published 2014, IDS of 01/17/2025).
Chen teaches the clinical pharmacokinetics and pharmacodynamics of lenalidomide (title).
Chen teaches that gelatin capsules for oral administration of lenalidomide are known (pg. 140, Col. 1 “Formulations”). Chen teaches that patients with dysphagia, such as the elderly and children, have difficulty swallowing capsules. However, because lenalidomide is a teratogenic drug, opening the capsules to form a solution or suspension, is not recommended (pg. 140, paragraph spanning Cols. 1-2).
Chen teaches that lenalidomide suspension formulations for patients with dysphagia is currently in clinical studies (pg. 140, Col. 1 “Formulations”).
Regarding instant claim 17, while Chen teaches that suspension formulations of lenalidomide are known, it differs from that of the instantly claimed suspension in that it does not teach a non-aqueous formulation comprising a surfactant, a suspending agent, pharmaceutically acceptable excipient, and a medium chain fatty acid triglyceride, and does not teach the lenalidomide in an amount of about 5mg/mL.
First teaches stable liquid oily ready-to-use oral formulations comprising an active pharmaceutical ingredient, which has hydrophobic and/or lipophilic properties and/or which exhibits stability problems in aqueous environments (abstract, pgs. 13-14, claims 1, 15).
First exemplifies the following suspension (Example 16 “Formulation 1,” [0164]):
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wherein Tween 80 is polyethoxylated sorbitan ester (surfactant), wherein Aerosil is colloidal silica (suspending agent), and wherein glyceryl distearate, Span 60, propyl gallate, sweetener and flavor are pharmaceutically acceptable excipients.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to select the non-aqueous liquid suspension of First as a suspension formulation for lenalidomide, to arrive at a non-aqueous liquid suspension comprising lenalidomide, polyethoxylated sorbitan ester, colloidal silica, pharmaceutically acceptable excipients, and medium chain fatty acid triglyceride. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Chen teaches that there is a need for liquid suspension formulations of lenalidomide and further teaches that such suspensions are already in clinical trial,
-First teaches its formulations for active pharmaceutical ingredients which exhibit stability problems in aqueous environments, and
-Song teaches lenalidomide as having poor solubility in water and consequently low oral bioavailability (Introduction, Col. 2).
As such, an ordinary artisan would be motivated to make such a selection, to predictably arrive at a formulation wherein lenalidomide is solubilized and thus has increased bioavailability, and is useful for administration to patients with dysphagia.
First further teaches its active pharmaceutical ingredients as comprising 1%, 2%, 0.4-8% or 10% of its formulation and teaches that the ratio of the active pharmaceutical ingredients and the oily vehicle ranges from 0.1-20%, preferably 0.5-10% and more preferably 1-10% ([0044]-[0045]).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to select a concentration of 5mg/mL lenalidomide as the concentration of lenalidomide in the combination of Chen, First and Song, to arrive at 5ng/mL lenalidomide. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-First exemplifies its active ingredients as comprising 0.4-10% of its formulations, and
-the optimization of known concentrations for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980); "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." MPEP 2144.05(II)
As such, an ordinary artisan be motivated to select 5mg/mL as concentration of lenalidomide in the combination of Chen, First and Song, to predictability arrive at a lenalidomide formulation that is therapeutically effective to treat hematologic malignancies (Chen, pg. 139, Col. 2 “Introduction”).
Regarding the phrase “wherein the medium chain triglyceride stabilizes lenalidomide against hydrolysis,” since the combination of Chen, First, and Song teach the instantly claimed composition, the medium chain triglyceride would reasonably be necessarily be expected to stabilize lenalidomide against hydrolysis. See MPEP 2141.02(V).
Regarding claims 18-19, First teaches caproic acid (C6), caprylic acid (C8), capric acid (C10) and lauric acid (C12) triglycerides as MCT’s ([0036]).
Regarding claims 20-22, First teaches 0.97-2.45% polyethoxylated sorbitan ester, i.e., Tween 80; in the case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art” a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding claims 23-25, First teaches colloidal silica, i.e., colloidal silicon dioxide or Aerosil.
Regarding claim 26, First teaches sweetener and flavoring.
Regarding claim 27, First exemplifies sucralose as the sweetener ([0123]-[0124], [0137], [0191]).
Regarding claim 28, First does not teach its suspension as comprising water.
Claim 29 is directed toward the intended use of the instant composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. In the instant case, since the prior art suspension is capable of performing the intended use, it meets the claim.
Regarding claim 30, the combination of Chen, First, and Song, as discussed above, teaches the instantly claimed suspension.
Regarding the phrase “wherein the colloidal silica is present in an amount effective to suspend lenalidomide in the medium chain triglyceride,” since the combination of Chen, First, and Song teach the instantly claimed composition and teaches an amount of colloidal silica within the range of the instantly claimed amount, the colloidal silica would reasonably be expected to be present in an amount effective to suspend lenalidomide in the medium chain triglyceride. See MPEP 2141.02(V).
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Regarding claim 31, First teaches 0.97-2.45% polyethoxylated sorbitan ester, i.e., Tween 80; in the case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art” a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding claims 32, First teaches 0-2% colloidal silica, i.e., colloidal silicon dioxide or Aerosil; in the case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art” a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding claim 33, though the combination of Chen, First, and Song does not teach the medium chain triglyceride present q.s. to 1mL, First teaches its formulations as “MCT q.s.” (pg. 7, Example 14) and teaches the oily vehicle as comprising 0.1-20% of the formulation (pg. 14, claims 13, 27) and teaches completing the volume with the oily vehicle to the desired amount (pg. 14, claim 17; [0057]).
As such, an ordinary artisan would have been motivated to modify the amount of medium chain triglyceride in Example 16 to present q.s. to 1mL, with a reasonable expectation of success, because:
-First teaches its formulations as MCT q.s.,
-teaches its formulations as completing the volume with the oily vehicle to the desired amount, and
-the optimization of known amounts/concentrations for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences. It has been held that the selection of optimal parameters, such as amounts/concentrations of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Regarding claims 34-36, the combination of Chen, First, and Song, as discussed above, teaches the instantly claimed suspension.
Claims 30-33 are rejected under 35 U.S.C. 103 as being unpatentable over WO2020/053665 to Patel (published 03/19/2020, PTO-892).
Patel teaches liquid oral suspensions and exemplifies the following suspension:
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(pgs. 18-19; pg. 21, claim 1; abstract).
Regarding claims 30 and 31, Patel differs in that it does not teach polyethoxylated sorbitan ester as the surfactant or the %w/w of polyethoxylated sorbitan ester.
Patel teaches either caprylocaproyl macrogol-8 glyceride or polyethoxylated sorbitan esters as surfactants (pgs. 21-22, claim 6).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to substitute the 5% caprylocaproyl macrogol-8 glyceride with 5% polyethoxylated sorbitan ester, to arrive at instant claim 30. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because Patel teaches caprylocaproyl macrogol-8 glyceride or polyethoxylated sorbitan esters as surfactants in its suspensions and substituting equivalents known for the same purpose is prima facie obvious, see MPEP 2144.06.
Since Patel teaches the instantly claimed suspensions in instantly claimed preferred amounts, the medium chain triglycine would reasonably be expected to stabilize lenalidomide against hydrolysis, and the colloidal silica would reasonably be expected to be in an amount effective to suspend lenalidomide in the medium chain triglyceride. See MPEP 2141.02(V).
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Further, Patel teaches “it is believed that medium chain triglycerides exhibit excellent stabilization capability for alkylating agents which are sensitive to hydrolysis (e.g. temozolomide or lenalidomide)” ([0039]).
For the limitations of claims 32-33, see above Table 5 of Patel.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 17, 20-26, and 28-36 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,303,504 (PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.,
Regarding claims 17, 20-26, 28, 30-32, 34-36, ‘504 claims a non-aqueous liquid pharmaceutical suspension comprising about 5mg/mL lenalidomide, about 1-2% w/w polyethoxylated sorbitan ester, about 1-1.25% w/w colloidal silica, one or more pharmaceutically acceptable excipients, and a medium chain fatty acid triglyceride as a vehicle (claims 1, 11).
Regarding claim 26, ‘504 claims a sweetener, a flavoring agent, and a preservative as the one or more pharmaceutically acceptable excipients (claim 4).
In claims 17 and 30, regarding the phrase “wherein the medium chain triglyceride stabilizes lenalidomide against hydrolysis,” since ‘504 claims the instantly claimed composition, the medium chain triglyceride would reasonably be expected to stabilize lenalidomide against hydrolysis. See MPEP 2141.02(V).
In claim 30, regarding the phrase “wherein the colloidal silica is present in an amount effective to suspend lenalidomide in the medium chain triglyceride,” since ‘504 claims the instantly claimed composition and teaches an amount of colloidal silica within the range of the instantly claimed amount, the colloidal silica would reasonably be expected to be present in an amount effective to suspend lenalidomide in the medium chain triglyceride. See MPEP 2141.02(V).
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Claim 29 is directed toward the intended use of the instant composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. In the instant case, since the prior art suspension is capable of performing the intended use, it meets the claim.
Regarding claim 33, though ‘504 does not claim the medium chain triglyceride present q.s. to 1mL, ‘504 claims the medium chain fatty triglyceride as a vehicle present in an amount from about 70% w/w/ to about 99% w/w (claims 6-7).
As such, an ordinary artisan would have been motivated to modify the amount of medium chain triglyceride in ‘504 as present q.s. to 1mL because ‘504 claims its suspensions as comprising about 70-99% w/w of the suspensions, and the optimization of known amounts/concentrations for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts/concentrations of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Claims 18-19 and 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,303,504 (PTO-892), as applied to claims 17, 20-26, and 28-36, above, and further in view of US20130115294 to First (published 2013, IDS of 01/17/2025).
‘504 is applied as discussed above and incorporated herein.
Regarding claims 18-19, ‘504 differs in that it does not claim specific MCTs.
First is applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select the caproic acid (C6), caprylic acid (C8), capric acid (C10) and lauric acid (C12) triglycerides taught by First as the MCT’s of ‘504, to arrive at instant claims 18-19. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-First and ‘504 are directed toward similar oral, liquid suspensions comprising MCTs and lipophilic active ingredients, and
-First teaches caproic acid (C6), caprylic acid (C8), capric acid (C10) and lauric acid (C12) triglycerides as acceptable medium chain triglycerides for use in such suspensions.
Regarding claim 27, ‘504 differs in that it does not claim sucralose as the sweetener.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select the sucralose taught by First as the sweetener in ‘504, to arrive at instant claim 27. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-First and ‘504 are directed toward similar oral, liquid suspensions comprising sweeteners, and
-First teaches sucralose as an acceptable sweetener for use in such suspensions.
Claims 17 and 20-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of copending Application No. 19/757,346 (claim set dated 07/29/2026 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 17, 20-22, 28, 30-31, and 34, ‘346 claims:
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In claims 17 and 30 regarding the phrase “wherein the medium chain triglyceride stabilizes lenalidomide against hydrolysis,” since ‘346 claims the instantly claimed composition, the medium chain triglyceride would reasonably be expected to stabilize lenalidomide against hydrolysis. See MPEP 2141.02(V).
In claim 30 regarding the phrase “wherein the colloidal silica is present in an amount effective to suspend lenalidomide in the medium chain triglyceride,” since ‘346 claims the instantly claimed composition and teaches an amount of colloidal silica within the range of the instantly claimed amount, the colloidal silica would reasonably be expected to be present in an amount effective to suspend lenalidomide in the medium chain triglyceride. See MPEP 2141.02(V).
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Regarding claims 23-25, 32, and 35-36, ‘346 claims the suspending agent as colloidal silica/colloidal silicon dioxide (claims 3-4).
Regarding claims 26-27, ‘346 claims peppermint flavor as a flavoring agent (claims 6-8).
Claim 29 is directed toward the intended use of the instant composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. In the instant case, since the prior art suspension is capable of performing the intended use, it meets the claim.
Regarding claim 33, ‘346 claims the medium chain triglyceride is present q.s. to 1 mL (claim 5).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 18-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of copending Application No. 19/757,346 (claim set dated 07/29/2026 (reference application), as applied to claims 17 and 20-36, and further in view of US20130115294 to First (published 2013, IDS of 01/17/2025).
‘346 is applied as discussed above and incorporated herein.
Regarding claims 18-19, ‘346 differs in that it does not claim specific MCTs.
First is applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select the caproic acid (C6), caprylic acid (C8), capric acid (C10) and lauric acid (C12) triglycerides taught by First as the MCT’s of ‘346, to arrive at instant claims 18-19. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-First and ‘346 are directed toward similar oral, liquid suspensions comprising MCTs and lipophilic active ingredients, and
-First teaches caproic acid (C6), caprylic acid (C8), capric acid (C10) and lauric acid (C12) triglycerides as acceptable medium chain triglycerides for use in such suspensions.
Conclusion
No claims are allowed.
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/LAUREN WELLS/Primary Examiner, Art Unit 1622
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