DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 15 December 2025 has been entered, and the arguments presented therein have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Withdrawn Prior Art Rejections
Previously in the office action, the examiner rejected the instant claims as obvious over the combination of Yiling et al. (CN 102085194 A1) in view of Venkatesh et al. (US 2009/0169620 A1), also in combination with other references to reject dependent claims. These obviousness rejections been withdrawn for at least the following reasons:
As an initial matter, applicant takes the following position on page 7 of applicant’s response on 15 December 2025 (hereafter referred to as applicant’s most recent response), regarding the English translation of Yiling et al. (CN 102085194 A1).
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In view of this, the examiner has relied upon the above indicated translation of Yiling for examination in this office action.
As best understood by the examiner, the actual example of Yiling teaches the following composition in the following amounts, as of Yiling, claim 1, reproduced below.
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The concentration of levetiracetam appears to be the following:
250
L
E
V
250
L
E
V
+
500
P
E
G
+
100
M
a
l
t
o
d
e
x
t
r
i
n
+
2
G
e
l
a
t
i
n
=
250
852
≈
29.4
%
L
E
V
As such, the amount of levetiracetam appears to be about 29.4%. This amount is significantly lower than the minimum of 50% required by claim 1 and the minimum of 60% required by claim 27.
The examiner notes that in some instances, it may be prima facie obvious to optimize concentrations of ingredients, as per the guidance set forth in MPEP 2144.05(II)(A). However, claims 1 and 27 also recite that the matrix disperses in about 15 seconds or less in a volume of 15 mL or less of water or saliva. In this case, the relevant issue for determining whether the instant claims are obvious is not only whether it would have been obvious for the skilled artisan to have optimized the concentration of levetiracetam, but also whether there would have been a reasonable expectation that the composition that would have formed a result of this optimization would have had a matrix which disperses in about 15 seconds or less in a volume of about 15 mL or less of water or saliva. In order to properly support a rejection on the basis that an invention is the result of "routine optimization", the examiner must make findings of relevant facts, and present the underpinning reasoning in sufficient detail. The articulated rationale must include an explanation of why it would have been routine optimization to arrive at the claimed invention and why a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See MPEP 2144.05(II)(B). It is the examiner’s position that there is no reasonable expectation of success in this case, for reasons set forth below.
Applicant may present evidence showing a lack of a reasonable expectation of success. See MPEP 2143.02(II). In this case, applicant does appear to have presented such evidence. See the declaration under 37 C.F.R. 1.132 that was submitted on 15 December 2025 (hereafter referred to as the declaration). Declarant takes the following position as of page 11, paragraph #55 of the declaration, which is reproduced below.
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The examiner agrees that, had the skilled artisan optimized the formulation of Yiling to have had 50% levetiracetam, the skilled artisan would have expected the resulting formulation to have dissolved and/or dispersed more slowly than what is required by the instantly claimed invention. However, applicant appears to have achieved the required dispersion and/or dissolution rate despite using a higher amount of levetiracetam as compared to what was used by the prior art. Proceeding contrary to the accepted wisdom is evidence of non-obviousness; see MPEP 2145(X)(D)(3). In this case, it appears that the accepted wisdom would have been that increasing the levetiracetam concentration to have been 50% or higher would have resulted in slower dissolution and/or dispersion. However, applicant achieved faster dissolution and dispersion by increasing the concentration of levetiracetam, thereby going against the accepted wisdom of reducing the concentration of levetiracetam to increase dissolution and dispersion time. This rationale is especially relevant regarding instant independent claim 27, which recites both the dissolution time and the dispersion time.
The examiner notes there that the instant application indicates that dispersion (e.g. of the matrix) and dissolution (e.g. of levetiracetam) are, for the purposes of this application, two different processes. See the instant specification on pages 14-15, paragraph 0055. This determination is additionally made in view of the fact that claim 1 recites that dispersion occurs in about 15 seconds or less, whereas claim 11, which ultimately depends upon claim 1, recites that 75% of active agent is dissolved after about 2 minutes. As such, dissolution occurs on a longer timescale than dispersion and dissolution is therefore understood to refer to a different process as compared with dispersion. Regardless, the examiner takes the position that the skilled artisan would have expected dispersion time and dissolution time to have been correlated because the skilled artisan would have expected that the failure of a matrix disperse would have reduced the surface area of the active agent available for dissolution. As such, the skilled artisan would have expected a composition with a longer dissolution time to have had a longer dispersion time and vice versa, and would have expected a composition with a shorter dissolution time to have had a shorter dispersion time and vice versa.
Consequently, the skilled artisan would have expected that modifications that would have caused a lengthening of the dissolution time would have also caused lengthening of the dispersion time. As such, the statements in paragraph #55 of the declaration would have indicated that the skilled artisan would have expected that had the composition of Yiling been modified to have achieved 50-80% of levetiracetam, the skilled artisan would have expected that such a composition would have dissolved much more slowly than what is required by instant claims 11 and 27. Therefore, the skilled artisan would have also expected that such a composition would have had a slower dispersion time than what is required by claim 1 because the skilled artisan would have had a reasonable expectation that dispersion and dissolution would have been reasonably correlated.
The information provided in the declaration also explain the differences between levetiracetam, which was the drug used by Yiling, and temazepam, which was the drug used by Venkatesh et al. (US 2009/0169620 A1). Paragraphs #39-40 of the declaration speaks to concentration and solubility differences between these drugs, teaching that levetiracetam is a highly water-soluble drug whereas temazepam is poorly water-soluble. As such, the differences between levetiracetam and temazepam would have resulted in the teachings of Venkatesh not being particularly applicable to levetiracetam.
The examiner notes that the first line of instant claim 1 recites that the composition is three-dimensionally printed. This is a product-by-process limitation. The examiner notes that once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing a nonobvious difference between the claimed product and the prior art product. See MPEP 2113(II). In this case, it appears as if this burden has been met in view of information provided in the declaration. Specifically, declarant declares the following, as of paragraph 57, which is reproduced below.
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This would appear to indicate that the process by which the composition is made would have resulted in different properties, particularly related to the disintegration time of the composition. The examiner understands the phrase “disintegration time,” which was used in the declaration, to refer to the same concept as the matrix dispersion time required by the claims. As such, the evidence set forth in paragraph #57 further bolsters applicant’s position that the skilled artisan would not have expected the composition of Yiling to have had the required matrix dispersion time because it was not made by three-dimensional printing.
As such, the evidence in paragraph #57 of the declaration would appear to show that the skilled artisan would not have expected the required dispersion time to have been inherent in the composition of Yiling because Yiling was not prepared by the three-dimensional printing process required by the instant claims. Additionally, given fact that the composition of Yiling was not prepared by three-dimensional printing, it appears that the skilled artisan would not have had a reasonable expectation that the composition of Yiling could have been successfully optimized to have had a matrix dispersion time in the claimed requirements of 15 seconds or less.
In view of the examiner’s decision to withdraw the prior art rejections, the examiner has not substantively addressed the arguments presented in applicant’s response on 15 December 2025 regarding the previously presented obviousness rejections.
Non-Statutory 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 1-3, 5, 7, 9-16, 20-21, and 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 9,339,489 in view of Tian et al. (US 2006/0100214 A1).
Instant claim 1 is drawn to a solid, orally disintegrating dosage comprising levetiracetam, along with disintegrant and binder. The claim recites that the composition is three dimensionally printed. Claim 7 recites a hardness of from 2 kp to 6 kp.
Conflicting claim 1 is drawn to a solid, orally disintegrating dosage comprising levetiracetam, along with disintegrant and binder. Conflicting claim 1 recites that the matrix has a hardness of at least 2 kp. The composition of the conflicting claims is three dimensionally printed.
The instant and conflicting claims differ because instant claim 1 recites particular substances from which the disintegrant may be selected, which are not recited by conflicting claim 1. As such, there is no case of statutory double patenting.
Tian et al. (hereafter referred to as Tian) is drawn to a fast-dissolving tablet, as of Tian, title and abstract. Tian teaches that the disintegrant may be croscarmellose cellulose, crospovidone (i.e. crosslinked polyvinyl pyrrolidone) and sodium starch glycollate (i.e. sodium starch glycolate), as of Tian, page 9, left column, claim 21 of Tian.
It would have been prima facie obvious for one of ordinary skill in the art to have used the croscarmellose, crospovidone, or sodium starch glycolate of Tian as the disintegrant in the composition of the conflicting claims. The conflicting claims are drawn to an orally disintegrating composition and recite the presence of a disintegrant; however, the conflicting claims are silent as to the chemical identity of the disintegrant. Tian teaches that croscarmellose, crospovidone, and sodium starch glycolate are disintegrants. As such, the skilled artisan would have been motivated to have used croscarmellose, crospovidone, or sodium starch glycolate in the composition of the conflicting claims to have predictably acted as disintegrants with a reasonable expectation of success. Generally, it is prima facie obvious to select a known material (e.g. croscarmellose, crospovidone, or sodium starch glycolate of Tian) for incorporation into a composition (that of the conflicting claims), based on its recognized suitability for its intended use (e.g. as disintegrants). See MPEP 2144.07.
Claims 1-3, 5, 7, 9-16, 20-21, and 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9,669,009 in view of Tian et al. (US 2006/0100214 A1).
Instant claim 1 is drawn to a solid, orally disintegrating dosage comprising levetiracetam, along with disintegrant and binder. The claim recites that the composition is three dimensionally printed. Claim 7 recites a hardness of from 2 kp to 6 kp.
The conflicting claims are drawn to a method of treating a disease by administering a solid, orally disintegrating dosage comprising levetiracetam, along with disintegrant and binder. Conflicting claims 29-30 recite that the matrix has a hardness of at least 2 kp. The composition of the conflicting claims is three dimensionally printed, as of conflicting claims 29-30. The composition administered by the method of the conflicting claims is three-dimensionally printed and comprises a binder and disintegrant. The composition used in the method of the conflicting claims appears to disperse in 15 seconds or less.
The instant and conflicting claims differ because instant claim 1 recites particular substances from which the disintegrant may be selected, which are not recited by conflicting claim 1. As such, there is no case of statutory double patenting.
Tian et al. (hereafter referred to as Tian) is drawn to a fast-dissolving tablet, as of Tian, title and abstract. Tian teaches that the disintegrant may be croscarmellose cellulose, crospovidone (i.e. crosslinked polyvinyl pyrrolidone) and sodium starch glycollate (i.e. sodium starch glycolate), as of Tian, page 9, left column, claim 21 of Tian.
It would have been prima facie obvious for one of ordinary skill in the art to have used the croscarmellose, crospovidone, or sodium starch glycolate of Tian as the disintegrant in the composition of the conflicting claims. The conflicting claims are drawn to an orally disintegrating composition and recite the presence of a disintegrant; however, the conflicting claims are silent as to the chemical identity of the disintegrant. Tian teaches that croscarmellose, crospovidone, and sodium starch glycolate are disintegrants. As such, the skilled artisan would have been motivated to have used croscarmellose, crospovidone, or sodium starch glycolate in the composition of the conflicting claims to have predictably acted as disintegrants with a reasonable expectation of success. Generally, it is prima facie obvious to select a known material (e.g. croscarmellose, crospovidone, or sodium starch glycolate of Tian) for incorporation into a composition (that of the conflicting claims), based on its recognized suitability for its intended use (e.g. as disintegrants). See MPEP 2144.07.
Claims 1-3, 5, 7, 9-16, 20-21, and 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,396,979. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
Instant claim 1 is drawn to a solid, orally disintegrating dosage comprising levetiracetam, along with disintegrant and binder. The claim recites that the composition is three dimensionally printed. Claim 7 recites a hardness of from 2 kp to 6 kp.
Conflicting claim 1 is drawn to a solid, orally disintegrating dosage consisting essentially of drug, disintegrant, glycerin, and binder, as of conflicting claim 1. Conflicting claim 14 recites that the drug is levetiracetam. Conflicting claim 12 recites disintegrant in amounts of 3-35%, and conflicting claim 13 recites binder in amounts of 0.5-20%.
The instant and conflicting claims differ because instant claim 1 recites levetiracetam, which is not recited by conflicting claim 1. As such, there is no case of statutory double patenting. Nevertheless, the skilled artisan would have been motivated to have combined the amounts of disintegrant and binder from conflicting claims 12 and 13. The result of this combination would have rendered the claimed invention prima facie obvious. This would have resulted in a prima facie case of obviousness-type non-statutory double patenting.
Response to Arguments Regarding Double Patenting Rejections
Applicant does not appear to have provided substantive arguments regarding the double patenting rejections. In response, applicant states that a terminal disclaimer will be filed upon indication of allowance of the claims of the present application, as of applicant’s response on 15 December 2025, paragraph bridging pages 20-21. As such terminal disclaimers have not been filed, the instant claims are not in condition for allowance and the double patenting rejections have been maintained.
Relevant Patent – No Double Patenting
As a relevant patent, the examiner cites US Patent 11,160,786, which as the same inventors as the instant application. The ‘786 patent claims are drawn to a rapidly dispersible oral dosage form comprising a binder and disintegrant, as well as an active agent. However, the ‘786 patent claims do not recite levetiracetam, which is the active agent required by the instant claims. In view of this, the examiner has decided not to reject the instant claims over the claims of the ‘786 patent on the grounds of non-statutory double patenting.
Conclusion
No claim is allowed.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612