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
Status of the Claims
Applicant’s cancelation of claims 5, 19, and 20 in the response filed on February 3rd 2026 is acknowledged. Claims 1-4 and 6-18 are pending and are examined on their merits.
Typographical Errors Fixed
Applicant’s amendments in the response filed on February 3rd 2026 have fixed all of the typographical errors mentioned in the non-final rejection filed on November 3rd 2025.
35 U.S.C. § 112(b) Rejections Overcome by Amendment
Applicant has amended claim 10 to no longer recite “the combination therapy,” thus overcoming the 112(b) rejection for claim 10. Applicant has removed the term “around” from claim 13, thus overcoming the 112(b) rejection for claim 15. Applicant has amended claim 16 to a form wherein sufficient antecedent basis is provided, thus overcoming the 112(b) rejection for claim 16. Applicant has fixed the contradictory claim language in claim 18, thus overcoming the 112(b) rejection for claim 18.
35 U.S.C. § 112(a) Rejections Overcome by Amendment
Applicant has amended claims 1 and 3 to only recite crystal structures which are fully supported by the specification. The 112(a) rejections for claims 1, 3, and their dependent claims are thereby withdrawn.
35 U.S.C. § 102 Rejections Overcome by Amendment
Applicant’s amendments to claim 1 in the response filed on February 3rd 2026 are acknowledged. Applicant has amended claim 1 to recite a particular pharmaceutical composition comprising the claimed crystal structure instead of the structure itself. As this composition was not recited by Qian, the 102 rejections are withdrawn.
35 U.S.C. § 103 Rejections Maintained and Applied to Amended Claims
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 rejection of claims 1-4 and 6-18 under 35 U.S.C. 103 as being unpatentable over Qian (U.S. Patent No. 9,657,017 issued on May 23rd 2017) in view of Patil (US 2023/0372249 A1 effectively filed on September 4th 2020) is maintained.
Applicant’s amendments and arguments in the response filed on February 3rd 2026 are acknowledged. Applicant has
Amended claim 1 to recite additional peaks for the crystal form
Amended claim 1 to require that the crystal form is in a particular pharmaceutical composition
Argued that the present pharmaceutical composition has unexpected synergistic properties over the art.
Regarding (1), the additional peaks, clam 1 now requires:
An XRPD pattern comprising peaks at 8.6, 13.1, 15.3, 16.0, 17.9, 19.3, and 22.3 ± 0.2 degrees 2Θ. Qian teaches peaks at 8.3±0.2°, 13.4±0.2°, 15.1±0.2°, 15.7±0.2°, 17.9±0.2°, 19.0±0.2°, 21.9±0.2°. In EVERY case, the peaks share overlap within the standard described margin of error (Example: a peak at 22.3 ± 0.2° 2Θ would generally be recognized as the same as 21.9±0.2°). Thus, Qian’s crystal structure would be recognized as being the same as applicant’s crystal structure.
Regarding (2), the particular pharmaceutical composition, the described formulation requires:
40-80% of the crystalline form of praziquantel
35-45% of microcrystalline cellulose
0.5-3% of sodium lauryl sulfate
2-8% of sodium starch glycolate
1-8% of povidone K30
0.3-2% of colloidal silicon dioxide
0.1-5% of sodium stearyl fumarate
Each of these is demonstrated as being prima facie obvious in the 103 rejections in the non-final rejection filed on November 3rd 2025, with the exception of the microcrystalline cellulose, which is taught at a concentration of 25-30% (Patil, pg. 16, claim 10). However, this is just below the claimed microcrystalline cellulose range, and one of ordinary skill in the art would therefore recognize the change in microcrystalline cellulose concentration as a case of routine optimization (See MPEP 2144.05).
Regarding (3), applicant states that the claimed pharmaceutical composition represents an improvement in pharmokinetics, and references Table 12 of the specification. However, it is not clear that the purported improvement in pharmokinetics results from applicant’s particular pharmaceutical composition. For example, see Bagchus (Bagchus et al., (2019), Relative Bioavailability of Orally Dispersible Tablet Formulations of Levo- and Racemic Praziquantel: Two Phase I Studies. Clin Transl Sci, 12: 66-76; cited by applicant), who teaches that the pharmokinetics of praziquantel can vary dramatically even just from the amount of food ingested by the subject receiving administration. Without further evidence that the pharmokinetic improvement results from the particular aspects of the composition of claim 1, applicant’s claim of unexpected results is considered unsubstantiated and the 103 rejections over claims 1-4 and 6-18 are maintained.
35 U.S.C. § 102 and 103 Rejections From Previous Non-Final Rejection
Note that, as the limitations of claim 6 have been incorporated into the amended claim 1, the information from each is relevant in the rejection of the claims and has been included:
Previous 102 Rejections
Claim 1 is directed towards a pharmaceutical composition comprising an anhydrous crystalline form of (R)-praziquantel, characterized by an x-ray diffraction pattern comprising a peak at 13.1 ± 0.2 degrees 2Θ, water content between 0 and 1% w/w.
Qian teaches a crystalline form of (R)-praziquantel including a peak at 13.4 ± 0.2 degrees 2Θ (Qian, col. 20, claim 1). Qian’s peak (range of 13.2-13.6 degrees 2Θ) overlaps with applicant’s peak (range of 12.9-13.3 degrees 2Θ) and would therefore be recognized as identical. Qian further teaches that the crystal form had a purity of 99.4% (Qian, col. 15, Example 15), which would therefore constitute water content less than 2%. Qian further teaches a pharmaceutical composition comprising this crystal form (Qian, col. 21, claim 7). Qian therefore anticipates claim 1.
Claim 2 limits the composition of claim 1 to require impurity less than 1%. As Qian’s impurity is 0.6%, Qian anticipates claim 2.
Claim 3 limits the composition of claim 1 to require that the crystalline form of (R)-praziquantel comprises at least one peak from the following: 17.9, 19.3, 20.1, 20.9, 22.3, 24.8, 27.8, 31.2, or 34.5 ± 0.2 degrees 2Θ. Qian teaches a peak at 17.9 ± 0.2 degrees 2Θ (Qian, col. 20, claim 1), anticipating claim 3.
Claim 4 limits the form of the composition of claim 1 to one of many, including tablets. Qian teaches tablets (Qian, col. 21, claim 8), anticipating claim 4.
Claim 7 limits the composition of claim 5 to require particular excipients, such as methylcellulose. Qian teaches administration of the (R)-praziquantel in a composition comprising methylcellulose (Qian, col. 19, Example 20), anticipating claim 7.
Claim 10 limits the form of the pharmaceutical composition of claim 1 to be selected form a group that contains a ‘granular formulation.’ Qian teaches a granule form (Qian, col. 21, claim 8), anticipating claim 10.
Claims 13-14 are directed towards the pharmaceutical composition of claim 1 wherein the crystalline form is prepared by a particular process. Claims 13-14 are therefore product-by-process claims and are interpreted as such. See MPEP 2113:
PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE MANIPULATIONS OF THE RECITED STEPS, ONLY THE STRUCTURE IMPLIED BY THE STEPS
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.). Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n. 14, 92 USPQ2d 1289, 1312, n. 14 (Fed. Cir. 2009). See also Biogen MA Inc. v. EMD Serono, Inc., 976 F.3d 1326, 1334, 2020 USPQ2d 11129 (Fed. Cir. 2020) ("Biogen is certainly correct that the scope of composition and method of treatment claims is generally subject to distinctly different analyses. But where, as here, the novelty of the method of administration rests wholly on the novelty of the composition administered, which in turn rests on the novelty of the source limitation, the Amgen analysis will necessarily result in the same conclusion on anticipation for both forms of claims."); United Therapeutics Corp. v Liquidia Techs., Inc., 74 F.4th 1360, 1373, 2023 USPQ2d 862 (Fed. Cir. 2023) (the court held that product-by-process claims were properly rejected as "anticipated by a disclosure of the same product irrespective of the processes by which they are made."); and Purdue Pharma v. Epic Pharma, 811 F.3d 1345, 117 USPQ2d 1733 (Fed. Cir. 2016). However, in the context of an infringement analysis, a product-by-process claim is only infringed by a product made by the process recited in the claim. Id. at 1370 ("a product in the prior art made by a different process can anticipate a product-by-process claim, but an accused product made by a different process cannot infringe a product-by-process claim").
As Qian anticipates the pharmaceutical composition of claim 1, Qian therefore anticipates claims 13-14.
Claim 15 is directed towards a method for preventing or treating parasitic infections, diseases, or disorders via administration of the composition of claim 1. Qian teaches the treatment of parasitic diseases via administration of the compound (Qian, col. 21, claim 9), anticipating claim 15.
Claim 16 limits the disease of claim 15 to be selected from a list including clonorchiasis. Qian teaches the treatment of clonarchiasis (Qian, col. 21, claim 9), anticipating claim 15.
Claim 17 requires that the dosage of claim 15 is greater than 1 mg/kg when administered to an animal. Qian teaches administration at 75 mg/kg to a rat (Qian, col. 4), anticipating claim 17.
Claim 18 requires that the subject of claim 15 is a human, animal, or fish. Qian teaches administration to a rat (Qian, col. 4), anticipating claim 17.
Previous 103 Rejections
Claim 6 is directed towards the pharmaceutical composition of claim 1 wherein the composition is a tablet including 40-80% of the crystalline form of praziquantel and 20-60% excipients. Claim 8 is directed towards the composition of claim 1 (falling in the metes and bounds of claim 6) wherein the formulation is a tablet including:
40-80% of the crystalline form of praziquantel
30-50% of microcrystalline cellulose
0.5-2% of sodium lauryl sulfate
2-8% of sodium starch glycolate
1-8% of povidone K30
0.3-1% of colloidal silicon dioxide
0.3-3% of sodium stearyl fumarate
For the teachings of Qian as they relate to claim 1, see the above 102 rejection over Qian. Regarding the tablet formulation, Qian teaches tableted forms of the (R)-praziquantel (Qian, col. 4). Qian does not explicitly teach applicant’s formulation as described in claim 8. However, one of ordinary skill in the art would have a reasonable expectation of success in developing such a formulation, because similar formulations of praziquantel are already known in the art. For example, see Patil, who teaches a palatable veterinary dosage of praziquantel (Patil, pg. 16, claim 10) comprising:
25-30% of microcrystalline cellulose
0.4-0.6% of sodium lauryl sulfate
1-3% of povidone K30
0.5-1.5% colloidal silicon dioxide
Patil additionally teaches magnesium stearate as a lubricant in the composition at 0.5-1.5% (Patil, pg. 16, claim 10), and suggests sodium stearyl fumarate as a substitute for the magnesium stearate (Patil, pg. 8, paragraph [0079]), as well as croscarmellose sodium as a disintegrant at 3-5% (Patil, pg. 16, claim 10), with the option of sodium starch glycolate as a substitute (Patil, pg. 8, paragraph [0084]). As one of ordinary skill in the art would reasonably make these substitutions, would reasonably expect the non-excipient portion of the tablet to be the active praziquantel, and each of the described excipients falls within the metes and bounds described by the claim, applicant’s formulation and claims 6 and 8 are prima facie obvious.
Claim 9 is directed towards the composition of claim 8 wherein the formulation is a tablet including:
40-60% of the crystalline form of praziquantel
30-50% of microcrystalline cellulose
0.5-2% of sodium lauryl sulfate
5-8% of sodium starch glycolate
1-5% of povidone K30
0.3-1% of colloidal silicon dioxide
0.3-3% of sodium stearyl fumarate
As the formulation described above with the combination of Qian and Patel meets these conditions, claim 9 is prima facie obvious for the same reasons as claim 8.
Claim 11 limits the pharmaceutical composition of claim 10 to require that the composition contains an excipient at one of the specified weight percentages. One such excipient is microcrystalline cellulose at 1-30% by weight. For the teachings of Qian as they are relevant to claim 10, see the above 102 rejection for claim 10. Regarding the excipients, Patil teaches 25-30% microcrystalline cellulose alongside praziquantel (Patil, pg. 16, claim 10), rendering claim 11 prima facie obvious.
Claim 12 requires that the composition of claim 1 contains an additional active agent selected from a list that includes fenbendazole. For the teachings of Qian as they are relevant to claim 1, see the above 102 rejection for claim 1. Regarding the additional active ingredient, Patil teaches fenbendazole as an additional active ingredient (Patil, pg. 3, paragraph [0040]) alongside praziquantel. One of ordinary skill in the art would therefore have a reasonable expectation of success in using Qian’s crystal form of praziquantel alongside fenbendazole, and claim 12 is therefore prima facie obvious.
Nonstatutory Double Patenting Rejections Maintained
Applicant’s statement in the response filed on February 3rd 2026 that the nonstatutory double patenting rejections will be addressed when they are the only rejections remaining is acknowledged. The nonstatutory double patenting rejections are thereby maintained.
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 thatthe 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 1-5, 7, 10, and 13-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 9,657,017. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons stated above in the 102(a)(1) rejection over Qian.
Claims 6, 8-9 and 11-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 9,657,017 in view of Patil (US 2023/0372249 A1 effectively filed on September 4th 2020). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons stated above in the 102(a)(1) rejection over Qian.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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