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 .
Claims 73, 84, and 92 have been amended.
Claims 93-100 have been added.
Claims 1-72, 74, 77-78, 81-83, 85-86, 88-91 are cancelled.
Claims 73, 75, 76, 79, 80, 84, 87, and 92-100 are pending.
Claims 79-80 are withdrawn.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/20/2026 has been entered.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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 73, 75, 76, 84, 87, and 92-100 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. US 10912847 B2 in view of KUSUMA (Simple Design of Miniaturized Cabinet for Compounding Vitamin C Effervescent Tablet in Laboratory Scale. Innovare Academic Sciences. 2018.).
The patent teaches an effervescent MRI tablet for magnetic resonance imaging that comprises 0.5 g to 1.2 g manganese (II) tetrachloride, 0.25 g to 0.75 g of L-alanine, water soluble excipients, and an effervescent couple comprising a basic ingredient and an acidic ingredient wherein the effervescent tablet is for preparing an oral solution for use in MRI (claim 1). The composition further comprises polyethylene glycol 6000 (claim 6).
The patent does not specifically teach the step of compressing the mixture to provide a tablet or wherein the relative humidity is kept below 35%.
KUSUMA teaches a composition that is compressed into effervescent tablet form (Page 160, right column, paragraph 3). KUSUMA further teaches that effervescent tablets are widely used due to their fast onset of action, good stomach and intestinal tolerance, more portability, improved palatability, superior stability, more consistent response, incorporation of large amounts of active ingredients, accurate dosing, and improved therapeutic effect (Introduction, page 157, paragraph 2).
KUSIMA also teaches that relative humidity in the laboratory is important when manufacturing effervescent tablets. The prerequisite for the controlled environment is due to the hygroscopic nature of the raw materials used for its production and chances of initiation of an effervescent reaction due to the uptake of moisture by these materials. Low relative humidity (maximum of 25% or less) in the manufacturing areas is essential to prevent the granulations or tablets from sticking to the machinery and from picking up moisture from the air, which may cause product degradation (Page 157, right column, paragraph 1).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate compressing the composition into an effervescent tablet. The person of ordinary skill in the art would have been motivated to make those modifications, because effervescent tablets have many benefits as listed in KUSUMA including but not limited to fast onset of action, good stomach and intestinal tolerance, more portability, and reasonably would have expected success because effervescent tablets are widely used in the art.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate having a relative humidity that is kept below 25%. The person of ordinary skill in the art would have been motivated to make those modifications, because as KUSUMA teaches Low relative humidity in the manufacturing areas is essential to prevent the granulations or tablets from sticking to the machinery and from picking up moisture from the air, which may cause product degradation, and reasonably would have expected success because laboratory and storage conditions are routinely designed to prevent damage to the products created.
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 (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 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 73, 75, 76, 84, 87, 92-94, and 97-99 are rejected under 35 U.S.C. 103 as being unpatentable over JOHANSSON (P.N. WO 2010/099804 A1) in view of KUSUMA (Simple Design of Miniaturized Cabinet for Compounding Vitamin C Effervescent Tablet in Laboratory Scale. Innovare Academic Sciences. 2018.) and BORTZ (P.N. US 2019/0125828 A1).
Regarding claim 73, JOHANSSON teaches a method for examination of the liver by using a contrast agent and MRI. This composition uses a manganese (II) compound (abstract), specifically manganese chloride tetrahydrate (Page 8, lines 17-19) in an amount of 0.8 g (Page 8, paragraph 2) and alanine, such as L-alanine (page 6, paragraph 1) in an amount of 0.5 g alanine (Page 8, paragraph 2).
JOHANSSON teaches this composition can be given orally in a tablet (Page 7, lines 18-20). This composition is created by adding the contrast agent, which further comprises disintegrants and fillers, manganese (II), amino acid are dispersed in water (page 6, paragraph 3), which reads on mixing the ingredients to create a water soluble mixture. This is can be formed into various edible/drinkable forms such as a tablet or a solution (page 7, paragraph 4), which reads on compressing the water-soluble mixture to provide the compressed solid MRI composition.
JOHANSSON does not teach having the composition be an compressing the composition to an effervescent tablet, adding an effervescent couple, having a relative humidity (RH) that is kept below 25% or adding PEG 6000.
KUSUMA teaches a composition that is compressed into effervescent tablet form (Page 160, right column, paragraph 3). The effervescent tablet is made using various ingredients including sodium bicarbonate and tartaric acid (Page 158, paragraph 4), which reads on effervescent couple. Applicant’s specification states that an “effervescent couple” is a pair of pharmaceutically acceptable excipients, one of which is basic and the other is acidic (Applicant’s specification, page 19, paragraph 2). KUSUMA further teaches that effervescent tablets are widely used due to their fast onset of action, good stomach and intestinal tolerance, more portability, improved palatability, superior stability, more consistent response, incorporation of large amounts of active ingredients, accurate dosing, and improved therapeutic effect (Introduction, page 157, paragraph 2). KUSIMA also teaches that relative humidity in the laboratory is important when manufacturing effervescent tablets. The prerequisite for the controlled environment is due to the hygroscopic nature of the raw materials used for its production and chances of initiation of an effervescent reaction due to the uptake of moisture by these materials. Low relative humidity (maximum of 25% or less) in the manufacturing areas is essential to prevent the granulations or tablets from sticking to the machinery and from picking up moisture from the air, which may cause product degradation (Page 157, right column, paragraph 1). KUSUMA further defines an effervescent tablet as a tablet which is dissolved or dispersed in water before administration (Page 157 introduction paragraph 2).
BORTZ teaches a composition that can be created into various forms such as a tablet, solution, gel, and effervescent tablet (Page 4, paragraph 0032), which is defined as a solid composition that can be dissolved in water to become an oral solution. The composition can be made of various components including manganese (Page 9, paragraph 0056), PEG 6000, which is used as a lubricant to reduce friction (Page 9, paragraph 0064), which reads on non-hygroscopic lubricant and amino acids (BORTZ claim 26).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate compressing the composition into an effervescent tablet that is made from an effervescent couple. The person of ordinary skill in the art would have been motivated to make those modifications, because effervescent tablets have many benefits as listed in KUSUMA including but not limited to fast onset of action, good stomach and intestinal tolerance, more portability, and reasonably would have expected success because effervescent tablets are widely used in the art according to KUSUMA and JOHANSSON teaches that their composition can be used in various forms.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate having a relative humidity that is kept below 25%. The person of ordinary skill in the art would have been motivated to make those modifications, because as KUSUMA teaches Low relative humidity in the manufacturing areas is essential to prevent the granulations or tablets from sticking to the machinery and from picking up moisture from the air, which may cause product degradation, and reasonably would have expected success because laboratory and storage conditions are routinely designed to prevent damage to the products created.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate using PEG 6000. The person of ordinary skill in the art would have been motivated to make those modifications, such as to use as a lubricant to reduce friction as stated in BORTZ, and reasonably would have expected success because JOHANNSON states various conventional pharmaceutical formulation aids can be added to the composition and a lubricant falls under this category.
Regarding claim 75, KUSUMA teaches an effervescent tablet as a tablet which is dissolved or dispersed in water before administration (Page 157 introduction paragraph 2) and it would be obvious to combine as discussed above.
Regarding claim 76, KUSUMA teaches a relative humidity below 25% (Page 157, right column, paragraph 1) and it would be obvious to combine as discussed above.
Regarding claim 84, JOHANSSON further teaches adding vitamin D as an uptake promoter (page 7, paragraph 2)
Regarding claim 87, JOHANSSON teaches manganese chloride tetrahydrate (Page 8, lines 17-19) in an amount of 0.8 g (Page 8, paragraph 2).
Regarding claim 92-93, JOHANSSON teaches a higher dose of the composition can be created with 1.6 g manganese chloride tetrahydrate and 1 g alanine and 1600 IE vitamin D3, which would add together to 2.6 g in the final composition (Page 8, Paragraph 2).
Regarding claim 94, JOHANSSON teaches alanine, such as L-alanine (page 6, paragraph 1) in an amount of 0.5 g alanine (Page 8, paragraph 2).
Regarding claim 97 ad 98, Note, the prior art’s method/composition would have the same chemical/physical properties of “wherein the effervescent MRI tablet provides a clear solution in 0.2 L water at room temperature within 5 minutes or less without stirring or agitation of the solution.” and “wherein the effervescent MRI tablet completely dissolves in water at room temperature within 5 minutes or less without stirring or agitation of the solution.” as claimed by Applicant, because the prior art has the same ingredients/steps as claimed by Applicant, unless proven otherwise.
Regarding claim 99, KUSUMA teaches a composition that is compressed into effervescent tablet form (Page 160, right column, paragraph 3) and it would be obvious to combine as discussed above.
Claims 73, 75, 76, 84, 87, and 92-100 are rejected under 35 U.S.C. 103 as being unpatentable over JOHANSSON (P.N. WO 2010/099804 A1), KUSUMA (Simple Design of Miniaturized Cabinet for Compounding Vitamin C Effervescent Tablet in Laboratory Scale. Innovare Academic Sciences. 2018.) and BORTZ (P.N. US 2019/0125828 A1) in view of PATEL (EMERGING TRENDS IN ORAL DISPERSIBLE TABLET. Journal of Drug Delivery & Therapeutics. 2013.).
JOHANSSON, KUSUMA and BORTZ teach Applicant’s invention as discussed above. JOHANSSON, KUSUMA and BORTZ further teach:
Regarding claim 95-in-part, KASUMA teaches the effervescent tablet is made using various ingredients including sodium bicarbonate and tartaric acid (Page 158, paragraph 4), which is used as an effervescent couple.
Regarding claim 100-in-part, JOHANSSON teaches a composition comprising manganese chloride tetrahydrate (Page 8, lines 17-19), alanine, such as L-alanine (page 6, paragraph 1) and vitamin D3 (page 6, paragraph 2). BORTZ teaches adding PEG 6000 (Page 9, paragraph 0064).
JOHANSSON, KUSUMA and BORTZ do not teach using citric acid, povidone or isomalt.
Regarding claims 95-in-part and 100-in-part, PATEL teaches that either citric acid or tartaric acid can be used in effervescent couples for effervescent tablets and can be combined with sodium bicarbonate (page 201, paragraph 10). Citric acid and sodium bicarbonate is an explicit example given (page 201, paragraph 6).
Regarding claim 96 and 100-in-part, PATEL teaches that povidone is added to compressed tablets as binders and also aids in disintegration and dissolution (page 205, paragraph 7) and isomalt can be added as a bulking agent and assists in taste masking properties and pleasing mouth feel (page 200, paragraph 7).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate citric acid. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because citric acid and tartaric acid are functional equivalents of organic acids commonly used in the pharmaceutical industry for effervescent tablets when using bicarbonate.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate povidone. The person of ordinary skill in the art would have been motivated to make those modifications, because it acts as a binder and also aids in disintegration and dissolution and reasonably would have expected success because the references are in the same field of endeavor, such as compressed tablets.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate isomalt. The person of ordinary skill in the art would have been motivated to make those modifications, because it is added as a bulking agent and assists in taste masking properties and pleasing mouth feel, and reasonably would have expected success because the references are in the same field of endeavor, such as compressed tablets.
Response to Arguments
Applicant argues, The Applicant respectfully submits that, despite the Office's assertions to the contrary, there is no reasonable expectation of success in the proposed combination of references. In particular, the Office asserts that there would be an expectation of success because effervescent tablets are widely used in the art, and because Johansson teaching their composition can be used in various administration forms. Johansson is completely silent to the uses of effervescent tablets. This, in combination with the teachings on p. 6, 1. 28-29 to keep the actives separate during storage amounts to a logically founded (albeit implicit) disclosure in Johansson to the expected incompatibility of effervescent tablets and the specified actives of the Johansson composition.
Examiner does not find the argument persuasive becaus it would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate compressing the composition into an effervescent tablet. The person of ordinary skill in the art would have been motivated to make those modifications, because effervescent tablets have many benefits as listed in KUSUMA including, but not limited to, fast onset of action, good stomach and intestinal tolerance, more portability, and reasonably would have expected success because effervescent tablets are widely used in the art according to KUSUMA and JOHANSSON teaches that their composition can be used in various forms.
Furthermore, aII references deaI with pharmaceutical compositions, so they are considered analogous art. It is common in the art to choose a composition form that will have the desired characteristics. Obviousness does not require complete predictability and less preferred embodiments do not constitute a teaching away.
Applicant argues, The statement in Kusuma related to 'fast onset of action' is, firstly, a relative term (by virtue of 'fast') made in relation to conventional tablets, not non-compressed powder formulations, but secondly-and importantly -'onset of action' is a term used in medicine for the time it takes for a drug to assert its therapeutic effect after administration. Onset of action for effervescent tablets (in Kusuma or elsewhere) can only logically refer to an effect observed following dissolution and oral consumption/administration and should/could not hold any relation to the dissolution rate of an effervescent tablet which is an action in isolation of the downstream onset of action. Effervescent tablets are specifically designed for being dissolved prior to administration and any discussion and/or evaluation of technical effects taking offset in consumption/administration of a non-dissolved effervescent formulation is not technically sound (Kusuma p. 157, left column 3rd- last sentence of second paragraph). In contrast, the compressed solid effervescent MRI composition prepared according to the presently claimed method demonstrates a significantly faster dissolution characteristic compared to the non-compressed powder formulation that is dissolved in water as disclosed in Johansson. This is further evidence that a person having ordinary skill in the art would not have had a reasonable expectation of success in the proposed combination. A rationale to support a conclusion of obviousness is that "the combination [ of prior art elements] would have yielded nothing more than predictable results to one of ordinary skill in the art." MPEP § 2143.02 (emphasis added). By the nature of being non-compressed, a powder generally dissolves faster than a tablet, as the initial step of disintegration is bypassed. Conventionally, it is believed that powders will dissolve faster compared to compressed tablets due to the greater surface area of the powder formulations. However, the opposite effect is demonstrated in at least examples 19 and 20 of the instant application, showing the how the effervescent tablet formulation compares to a non-compressed powder formulation with the same active ingredients. Example 19 concludes that the effervescent tablet of the present disclosure disintegrates faster than 5 minutes in 0.2 L of water at a temperature between 5° C and 20° C, with a faster disintegration at the higher temperatures. Example 19 also demonstrates that the amount of time to dissolve the effervescent tablet is significantly shorter than the time to dissolve the powder formulation.
Examiner does not find the argument persuasive because although the reference is silent about a dissolution rate faster than a powder formulation, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories, 58 USPQ2d 1508 (CAFC 2001). "It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable." In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir.1990). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. /n re BaxterTravenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145. On this record, it is reasonable to conclude that the same composition made in the same way would have the same properties. The fact that Applicant may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method. Thus, the references teaches, either expressly or inherently, each and every limitation of the instant claims. Most importantly, this limitation of the dissolution rate is not specifically claimed. Further, if applicant is alleging unexpected results, the data presented is clearly not commensurate in scope with the instant claims, that are broad to the excipients and amounts thereof used in the claims, which is not reflected in the data presented showing a wide variety of excipients.
Furthermore, as taught by KASUMA effervescent tablets are known to have a fast onset of action, which suggests the data shown is not necessarily unexpected.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
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/S.L.M./ Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618
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