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 Claims
Receipt is acknowledged of the claim amendments filed on 23 April 2026. Claims 1-24 are cancelled. Claims 44-48 have been amended. Claims 55-69 have been added.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 44-54 in the reply filed on 23 April 2026 is acknowledged.
Applicant further elected NDMA as the N-nitroso compound, metformin as the active pharmaceutical ingredient, polypropylene as the base polymer, and PEG as the channeling agent.
Claims 25, 34 and 55-69 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 23 April 2026.
Newly submitted claims 55-69 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: The method of claims 55-69 are directed towards a method comprising providing first compartment comprising an entrained polymer, providing a bag within the first compartment, the bag defining an enclosure that contains a liquid within it, opening the enclosure to dispense the liquid; while the method of claims 44-54 are directed towards a method comprising providing a package comprising an enclosure, one or more pharmaceutical dosage forms housed within the enclosure, wherein a headspace is formed within a volume of the enclosure that is not occupied by the one or more pharmaceutical dosage forms, and an entrained polymer in the headspace, opening the enclosure to dispense the one or more pharmaceutical dosage forms. Therefore, the method of claims 44-54 and the method of claims 55-69 are mutually exclusive species. Claims to different species are mutually exclusive if one claim recites limitations disclosed for a first species but not a second, while a second claim recites limitations disclosed only for the second species and not the first. In the instant case, the species of the method of claims 44-54 includes limitations including that the one or more pharmaceutical dosage forms are housed in the same enclosure that the entrained polymer is in (e.g., no structural barrier is required between the dosage form and the entrained polymer as long as they are in a separate space in the enclosure), while the species of the method of claims 55-69 includes limitations including a liquid in a bag (e.g., bag is a structural barrier required between a liquid form and the entrained polymer) that is in a first compartment that comprises entrained polymer.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 44-54 are examined herein to the extent that the NDMA is the N-nitroso compound, metformin is the active pharmaceutical ingredient, polypropylene is the base polymer, and PEG is the channeling agent, e.g., applicant's elected species.
Information Disclosure Statement
The information disclosure statement (IDS) filed 09/30/2025 and 11/18/2025 have been considered by the Examiner. A signed and initialed copy of the IDS is included with the instant Office Action.
Claim Rejections - 35 USC § 112
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 44-54 are 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 44 recites “the pharmaceutical dosage form within the package” (emphasis added) in line 16, which lacks antecedent basis because claim recites “one or more pharmaceutical dosage forms” in line 2. A claim is indefinite when it contains words or phrases whose meaning is unclear … [which] could arise wherein a claim refers to ‘said lever' or ‘the lever' , where … two different levers are earlier recited and it is uncertain as to which is being referenced. See MPEP 2173.05(e). In the instant case, it is unclear if the recitation of “the pharmaceutical dosage form” refers to just one, more than one or all pharmaceutical dosage forms. Claim 45-54 are indefinite as they depend directly or indirectly from rejected indefinite claim 44. The recitation of “the pharmaceutical dosage form” in claim 44 should be amended to recite “the one or more pharmaceutical dosage forms”.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 44-47, 49-51 and 53-54 rejected under 35 U.S.C. 103 as being unpatentable over MULYE (WO 2022/182778 A1, publication date of 01 September 2022, cited in IDS filed 09/30/2025) in view of HEKAL (US 6,194,079; patent date of 27 February 2001, cited in IDS filed 09/30/2025) and PATEL (US 2021/0380529 A1, publication date of 9 December 2021).
Mulye is primarily directed towards systems and methods for reducing formation of NDMA, using a package that includes a pharmaceutical solid dosage packaging container (abstract).
Regarding claims 44-47 and 53-54, Mulye discloses providing pharmaceutical package and method of reducing NDMA (e.g., Nitroso compound contaminant) in pharmaceutical products including Metformin (e.g., for treating a patient having a medical condition with one or more pharmaceutical dosage forms that can form an N-nitroso compound contaminant, having a propensity to form the N-nitroso compound contaminant) (paragraph [00008]). Mulye discloses that a package and method with a type and amount of desiccant for Metformin’s specific drug chemistry to reduce NDMA while also maintaining Metformin’s stability and efficacy (e.g., provide a therapeutically effective amount of drug to the patient for treating the medical condition with improved patient safety by reducing the potential adverse effect associated with the one or more pharmaceutical dosage forms on account of the decrease in the amount of the N-nitroso compound contaminant) (paragraphs [00008] and [00024]). Mulye discloses that N-nitrosdimethylamine (NDMA) is classified as probably carcinogenic to humans by World Health Organization’s (WHO’s) International Agency for Research on Cancer (IARC) (paragraph [00003]). Mulye discloses a pharmaceutical package comprising a pharmaceutical solid dosage packaging container (e.g., enclosure), wherein the pharmaceutical solid dosage packaging container includes one or more desiccants and pharmaceutical product comprising an active ingredient disposed in the container (paragraph [00009]). Mulye discloses that the desiccant includes silica gel and activated carbon (paragraph [00010]). Mulye discloses that forms of desiccant includes particles, grains and powders (paragraph [00047]).
Mulye does not specifically teach an entrained polymer in the headspace that comprises the activated carbon that is dispersed within a base polymer, the entrained polymer being separate and apart from the one or more pharmaceutical dosage forms, opening the enclosure to dispense the one or more pharmaceutical dosage forms and administering the one or more pharmaceutical dosage forms. The deficiencies are made up for by the teachings of Hekal and Patel.
Hekal is primarily directed towards a polymer composition having an absorbing material that is entrained within the polymer (see abstract and entire patent).
Regarding claims 44, 47, 49, Hekal teaches a monolithic composition comprising a water-insoluble polymer, a hydrophilic agent and an absorbing material (column 1, lines 15-17). Hekal teaches that application in which moisture absorbing containers are desired include for medications whose efficacy is compromised by moisture (column 1, lines 35-37). Hekal teaches that the initial placement of medicines into a sealed moisture free container is usually controllable but once the medicine is received by the customer, the container must be repeatedly opened and closed to access the medication. Hekal teaches that each time the container is opened and unsealed, moisture bearing air will most likely be introduced into the container and sealed therein upon closure, unless this moisture is removed from the atmosphere or head space of the container. Hekal teaches that it is well known practice to include a desiccating unit together with the medication in the container. (column 1, lines 38-52). Hekal teaches that it is important that the desiccant used not be of a “dusting” nature that may contaminate and compromise the performance of the components in a container. Hekal teaches that it has be recognized as advantageous to expose a desiccating agent to the interior space of containers, while at the same time shielding the components from actual contact with the desiccating material (e.g., being separate and apart from the one or more pharmaceutical dosage forms/ in headspace not occupied by the one or more pharmaceutical dosage forms) (paragraph bridging columns 1 and 2). Hekal teaches composition with interconnecting channels that communicate the entrained absorbing material to appropriate areas of the exterior of the composition in a manner that permits the desired property to migrate from outside the plastic structure to interior locations where the absorbing material is positioned. Hekal teaches that the interconnecting channels are occupied by hydrophilic agents (e.g., channeling agents) that control the transmission rate into the composition that control the transmission rate into the composition (column 2, lines 27-38). Hekal teaches that the composition (e.g., entrained polymer) is in the form of including a liner that is in the interior of a container (e.g., entrained polymer being separate and apart from the one or more pharmaceutical dosage forms/ entrained polymer in headspace not occupied by the one or more pharmaceutical dosage forms) (column 3, lines 1-5; Figure 6). Hekal teaches hydrophilic agents (e.g., channeling agents) combined with a water-insoluble polymer that is used in the formation of shaped articles, wherein the water-insoluble polymer base includes polypropylene (e.g., base polymer) (column 4, lines 4-10). Hekal teaches that suitable hydrophilic agents (e.g., channeling agent) include poly(ethylene glycol) (column 4, lines 54-56). Hekal teaches that the absorbing material includes desiccating compounds (column 5, lines 6-8). Hekal teaches absorbing materials including silica and carbon-based materials including activated charcoal (e.g., activated carbon)(column 5, lines 52-62). Hekal teaches that the “absorbing material” is defined as a particle (column 5, lines 66-67).
Patel is high purity metformin hydrochloride with no detectable amount of N-Nitrosodimethylamine (NDMA) (abstract).
Regarding claim 44, Patel teaches metformin hydrochloride for the treatment of diabetes (paragraph [0002]). Patel teaches administering a therapeutically effective amount of a pharmaceutical composition comprising metformin hydrochloride (paragraph [0038]).
Regarding claims 50 and 51, Hekal teaches a composition with about 68% polypropylene (e.g., base polymer) and 20% of a desiccant (e.g., activated carbon) (column 15, lines 34-39; claim 1).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to perform a method that comprises providing effective amount of metformin in a solid dosage form that is a part of a package that contains a sealed container that the solid dosage of metformin is contained in, an entrained polymer that is including a liner in an interior of the container (e.g., being separate and apart from the one or more pharmaceutical dosage forms/ in headspace not occupied by the one or more pharmaceutical dosage forms) and comprises a water-insoluble polymer, a hydrophilic agent and a desiccant comprising silica gel and activated carbon; opening and unsealing the container to dispense a solid dosage of metformin; and administering the solid dosage form of metformin to a patient for treating diabetes; wherein the desiccant is in the form of particles, grains and powders; wherein the water-insoluble polymer includes polypropylene (e.g., base polymer); wherein the hydrophilic agent includes poly(ethylene glycol) (e.g., channeling agent); and wherein the desiccant comprising silica gel and activated carbon reduce NDMA while also maintaining Metformin’s stability and efficacy (e.g., for treating a patient having a medical condition with one or more pharmaceutical dosage forms that can form an N-nitroso compound contaminant, having a propensity to form the N-nitroso compound contaminant, provide a therapeutically effective amount of drug to the patient for treating the medical condition with improved patient safety by reducing the potential adverse effect associated with the one or more pharmaceutical dosage forms on account of the decrease in the amount of the N-nitroso compound contaminant). The person of ordinary skill in the art would have been motivated to make those modifications to: 1) allow the desiccating agent to be exposed to the interior space of containers while also shield the desiccant from being in contact with the drug dosage form, by entraining the desiccant of Mulye in the entrained polymer of Hekal; and administered the solid dosage form of Metformin to a patient in order to treat diabetes in the patient as taught by Patel. The person of ordinary skill in the art would have reasonably expected success because Mulye discloses providing pharmaceutical package and method of reducing NDMA (e.g., Nitroso compound contaminant) in pharmaceutical products including Metformin (e.g., for treating a patient having a medical condition with one or more pharmaceutical dosage forms that can form an N-nitroso compound contaminant, having a propensity to form the N-nitroso compound contaminant) (paragraph [00008]). Mulye discloses that a package and method with a type and amount of desiccant for Metformin’s specific drug chemistry to reduce NDMA while also maintaining Metformin’s stability and efficacy (e.g., provide a therapeutically effective amount of drug to the patient for treating the medical condition with improved patient safety by reducing the potential adverse effect associated with the one or more pharmaceutical dosage forms on account of the decrease in the amount of the N-nitroso compound contaminant) (paragraphs [00008] and [00024]). Mulye discloses that the desiccant includes silica gel and activated carbon (paragraph [00010]). Mulye discloses that forms of desiccant includes particles, grains and powders (paragraph [00047]). Hekal teaches a monolithic composition comprising a water-insoluble polymer, a hydrophilic agent and an absorbing material (column 1, lines 15-17). Hekal teaches that application in which moisture absorbing containers are desired include for medications whose efficacy is compromised by moisture (column 1, lines 35-37). Hekal teaches that the initial placement of medicines into a sealed moisture free container is usually controllable but once the medicine is received by the customer, the container must be repeatedly opened and closed to access the medication. Hekal teaches that each time the container is opened and unsealed, moisture bearing air will most likely be introduced into the container and sealed therein upon closure, unless this moisture is removed from the atmosphere or head space of the container. Hekal teaches that it is well known practice to include a desiccating unit together with the medication in the container. (column 1, lines 38-52). Hekal teaches that it is important that the desiccant used not be of a “dusting” nature that may contaminate and compromise the performance of the components in a container. Hekal teaches that it has be recognized as advantageous to expose a desiccating agent to the interior space of containers, while at the same time shielding the components from actual contact with the desiccating material (e.g., being separate and apart from the one or more pharmaceutical dosage forms/ in headspace not occupied by the one or more pharmaceutical dosage forms) (paragraph bridging columns 1 and 2). Patel teaches metformin hydrochloride for the treatment of diabetes (paragraph [0002]). Patel teaches administering a therapeutically effective amount of a pharmaceutical composition comprising metformin hydrochloride (paragraph [0038]).
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Mulye in view of Hekal and Patel as applied to claims 44-47, 49-51 and 53-54 above, and further in view of REZUKE (US 2017/0113203 A1, publication date of 27 April 2017).
Regarding claim 48, the method of claim 44 is described above in section 10.
Mulye, Hekal and Patel do not specifically teach that the activated carbon is a derivative of activated carbon and specifically is tris-activated carbon. The deficiency is made up for by the teachings of Rezuke.
Rezuke is primarily directed towards a filter composition effective in reacting with airborne or gaseous organic impurities that has longer lasting capability of adsorbing organic airborne impurities for a much longer period of time than untreated (abstract).
Regarding claim 48, Rezuke teaches activated carbon impregnated with tris-(hydroxymethyl) aminomethane or TRIS as a means for removing organic and inorganic airborne impurities (paragraph [0019]). Rezuke teaches that activated carbon impregnated with TRIS gives the advantage of using lower basis weight of the composite to achieve removal efficiency equal to or greater than the efficiency of other available products which use a heavier basis weight of activated carbon (paragraph [0043]).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to perform a method that comprises providing effective amount of metformin in a solid dosage form that is a part of a package that contains a sealed container that the solid dosage of metformin is contained in, an entrained polymer that is including a liner in an interior of the container (e.g., entrained polymer being separate and apart from the one or more pharmaceutical dosage forms/ entrained polymer in headspace not occupied by the one or more pharmaceutical dosage forms) and comprises a water-insoluble polymer, a hydrophilic agent and a desiccant comprising silica gel and activated carbon; opening and unsealing the container to dispense a solid dosage of metformin; and administering the solid dosage form of metformin to a patient for treating diabetes; wherein the desiccant is in the form of particles, grains and powders; wherein the water-insoluble polymer includes polypropylene (e.g., base polymer); wherein the hydrophilic agent includes poly(ethylene glycol) (e.g., channeling agent); and wherein the desiccant comprising silica gel and activated carbon reduce NDMA while also maintaining Metformin’s stability and efficacy (e.g., for treating a patient having a medical condition with one or more pharmaceutical dosage forms that can form an N-nitroso compound contaminant, having a propensity to form the N-nitroso compound contaminant, provide a therapeutically effective amount of drug to the patient for treating the medical condition with improved patient safety by reducing the potential adverse effect associated with the one or more pharmaceutical dosage forms on account of the decrease in the amount of the N-nitroso compound contaminant); and wherein the activated carbon is activated carbon impregnated with tris-(hydroxymethyl) aminomethane (TRIS). The person of ordinary skill in the art would have been motivated to make those modifications to obtain a method with increased efficacy in reducing NDMA (e.g., organic impurity) by substituting activated carbon impregnated with tris-(hydroxymethyl) aminomethane (TRIS) that is taught by Rezuke. The person of ordinary skill in the art would have reasonably expected success because Rezuke is a filter composition effective in reacting with airborne or gaseous organic impurities that has longer lasting capability of adsorbing organic airborne impurities for a much longer period of time than untreated (abstract). Rezuke teaches that activated carbon impregnated with TRIS gives the advantage of using lower basis weight of the composite to achieve removal efficiency equal to or greater than the efficiency of other available products which use a heavier basis weight of activated carbon (paragraph [0043]).
Claim 52 is rejected under 35 U.S.C. 103 as being unpatentable over Mulye in view of Hekal and Patel as applied to claims 44-47, 49-51 and 53-54 above, and further in view of VOELLMICKE (WO 2020/214632 A1, publication date of 22 October 2020, cited in IDS filed 09/30/2025).
Regarding claim 52, the method of claim 44 is described above in section 10.
Regarding claim 52, Hekal teaches that the entrained polymer composition is in the form of including films made by a thermal extrusion process (abstract; paragraph bridging columns 6 and 7; claim 13).
Mulye, Hekal and Patel do not specifically teach that the entrained polymer as a film has a thickness of from 0.1 to 1.2 mm. The deficiency is made up for by the teachings of Voellmicke.
Voellmicke is primarily directed towards a polymer composition comprising activated carbon that is used for sorption of formaldehyde from air, gas or liquids (abstract).
Regarding claim 52, Voellmicke teaches polymer composition comprising a base polymer, activated carbon and channeling agent (paragraph [0011]). Voellmicke teaches polymer composition formed by including extrusion to form including a film and the polymer composition is incorporated into a packaging material (paragraph [0012]). Voellmicke teaches that the polymer comprises polypropylene as the base polymer (paragraph [0013]). Voellmicke teaches the polymer composition is an entrained polymer composition comprising activated carbon uniformly distributed within the base polymer (paragraph [0042]). Voellmicke teaches that the entrained polymer as a film has a thickness of from 0.1 mm to 1.0 mm (paragraph [0059]).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to perform a method that comprises providing effective amount of metformin in a solid dosage form that is a part of a package that contains a sealed container that the solid dosage of metformin is contained in, an entrained polymer that is including a film in an interior of the container (e.g., entrained polymer being separate and apart from the one or more pharmaceutical dosage forms/ entrained polymer in headspace not occupied by the one or more pharmaceutical dosage forms) and comprises a water-insoluble polymer, a hydrophilic agent and a desiccant comprising silica gel and activated carbon; opening and unsealing the container to dispense a solid dosage of metformin; and administering the solid dosage form of metformin to a patient for treating diabetes; wherein the desiccant is in the form of particles, grains and powders; wherein the water-insoluble polymer includes polypropylene (e.g., base polymer); wherein the hydrophilic agent includes poly(ethylene glycol) (e.g., channeling agent); wherein the desiccant comprising silica gel and activated carbon reduce NDMA while also maintaining Metformin’s stability and efficacy (e.g., for treating a patient having a medical condition with one or more pharmaceutical dosage forms that can form an N-nitroso compound contaminant, having a propensity to form the N-nitroso compound contaminant, provide a therapeutically effective amount of drug to the patient for treating the medical condition with improved patient safety by reducing the potential adverse effect associated with the one or more pharmaceutical dosage forms on account of the decrease in the amount of the N-nitroso compound contaminant); and wherein the film has a thickness of from 0.1 mm to 1.0 mm. The person of ordinary skill in the art would have been motivated to make those modifications because Hekal teaches forms of entrain polymer including a film, and Voellmicke teaches substantially the same entrained polymer that can be in the form of films that have a thickness of from 0.1 mm to 1.0 mm, which a person of ordinary skill in the art would expect can be substituted as a suitable entrained polymer form, especially in the absence of evidence to the contrary. The person of ordinary skill in the art would have reasonably expected success because Hekal teaches that the entrained polymer composition is in the form of including films made by a thermal extrusion process (abstract; paragraph bridging columns 6 and 7; claim 13). Voellmicke teaches polymer composition comprising a base polymer, activated carbon and channeling agent (paragraph [0011]). Voellmicke teaches polymer composition formed by including extrusion to form including a film and the polymer composition is incorporated into a packaging material (paragraph [0012]). Voellmicke teaches that the polymer comprises polypropylene as the base polymer (paragraph [0013]). Voellmicke teaches the polymer composition is an entrained polymer composition comprising activated carbon uniformly distributed within the base polymer (paragraph [0042]). Voellmicke teaches that the entrained polymer as a film has a thickness of from 0.1 mm to 1.0 mm (paragraph [0059]).
Thus, the claimed invention as a whole is clearly prima facie obvious over the teachings of the prior art.
Conclusion and Correspondence
No claims are found allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN P NGUYEN whose telephone number is (571)270-5877. The examiner can normally be reached Monday-Friday 10am-6pm EST.
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/John P Nguyen/
Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
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