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
This action is in response to papers filed March 16, 2026. Applicant’s reply to the restriction/election requirement of January 16, 2026 has been entered. Claims 3-5, 12, 18, 19, 23, 25, 26, 38, 39, and 41 have been amended; and claims 7-11, 15-17, 21, 22, 24, 27-35, 37, and 40 have been canceled. Claims 1-6, 12-14, 18-20, 23, 25, 26, 36, 38, 39, 41, and 42 are pending in the application.
Priority
Applicant’s claim for the benefit of prior-filed WIPO International Application No. PCT/CN2022/077513, filed February 23, 2022 under 35 U.S.C 365(c), is acknowledged.
Acknowledgment is also made of Applicant’s claims for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy of WIPO International Application No. PCT/CN2021/081293, filed March 17, 2021, appears to have been received as required by 37 CFR 1.55.
Applicant further claims foreign priority based on Japanese Patent Application Nos. 2021-061229 and 2021-139972, filed in Japan on March 31, 2021 and August 30, 2021, respectively. It is noted, however, that Applicant has not filed a certified copy of either one of these Japanese Patent applications as required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election without traverse of Group III, claims 41 and 42, is acknowledged. Applicant’s elections of i) “determining the amount of drug absorbed from the oral dosage form at each time point” as the species of further step, and ii) “solubility of the drug” as the species of parameter being modulated are both also acknowledged. The Examiner has determined that claims 41 and 42 read on the elected subject matter.
Accordingly, claims 1-6, 12-14, 18-20, 23, 25, 26, 36, 38, and 39 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected subject matter, there being no allowable generic or linking claim.
Election was made without traverse in the reply filed on March 16, 2026. Claims 41 and 42 are currently under examination.
Abstract
The abstract of the disclosure is objected to for the following reason:
1. The abstract should be a concise summary of the key technical aspects of the invention which are new to the art to which the invention pertains. If the invention is a composition, the abstract should recite the key requisite active ingredients. If the method is a method, the abstract should recite the key requisite active steps.
2. The abstract merely discloses in abstract terms oral drug dosage forms having a desired drug release profile. These have been well known for well over 100 years and are thus not new to the art by any stretch of the imagination. Moreover, the abstract mentions making oral drug dosage forms by 3D printing. This is also not new to the art, but rather has been known since the 1980s, i.e. for about 50 years.
3. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art. However, this appears to be all the abstract really does, and merely in abstract and generic terms too. In effect, the reader is not properly informed of what the actual invention is, i.e. an actual composition with a requisite set of ingredients and/or a requisite structure; and/or an actual method with a requisite set of active steps that must be performed by the hand of man.
Correction is required. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 41 and 42 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 41 and 42 are really nothing but abstractions that are based on arbitrary and subjective choices and desires of a third party actor, which decisions appear to not have actually been made or articulated, and undefined and unknown parameters that seem to depend, at least in part, on test results of tests that are not properly defined and have not actually been performed yet. Applicant appears to be attempting to patent the basic, generic concept that its possible for one to design their own dosage form and then produce it by 3D printing. However, this basic concept does not constitute an actual, concrete invention under U.S. Patent law. The claims are thus not directed to an actual composition that is defined by a requisite set of ingredients or a requisite structure.
On the contrary, the claims lay out a roadmap for a third party actor to invent their own dosage form, which invention is wholly dependent on the whims and desires of the third party actor who must decide things like e.g. the drug, the target PK profile, the desired amount of the drug in the dosage form, the desired amount of the drug that should be released and the rate of release, and the desired amount of the drug that should be absorbed, where the drug should be absorbed and at what rate, and even the actual design itself of the dosage form, etc. In effect, the actual dosage form that is to be 3D printed is not only an unknown variable it is yet to be determined in reality even what the requisite parameters are, or even what the desired parameters are. Everything is based on the unknown subject’s arbitrary desires, choices, and test results, and their devising their own design, all of which are effectively abstract, undefined, and unknown. The steps laid out in the roadmap represent merely conventional data collection, and/or “thinking”, i.e. all abstractions. Then, there is the charge to “produce” the oral drug dosage form by 3D printing in the broadest and most generic of terms.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the 3D printing technique has long been well known in the art, and has been employed for years for making custom designed oral drug dosage forms. This judicial exception is not integrated into a practical application because the claims do not in fact define a particular set of requisite concrete active steps to be performed by the hand of man. Rather, the claims merely generically point to the well-known technique of 3D printing. The claims represent a drafting effort to monopolize any and all methods of making any and all oral drug dosage forms that an arbitrary subject may devise with their own design. The claims thus merely set out a generic roadmap in abstract form; i.e. want an oral drug dosage form having a drug with a desired PK profile, have to figure out the drug, the desired PK release profile, and the design of the dosage form, but once this is done it’s possible to make it by 3D printing. It’s up to a third party actor to devise and define the actual invention in final form, i.e. the actual dosage form to be 3D printed, and the method of 3D printing it.
Obviousness-Type Double Patenting (I and II)
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
I. Claims 41 and 42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-29 of U.S. Patent No. 10,350,822.
Claims 100 and 101 are directed to a method of making an oral drug dosage containing a drug and having a “desired” pharmacokinetic release profile which has been designed by an arbitrary subject comprising 3D printing the dosage form.
The claims of U.S. Patent No. 10,350,822 disclose a method of making an oral drug dosage form having a “desired” pharmacokinetic release profile comprising at least two modulated release layers/portions each comprising the drug and having different kinetic release profiles, the method comprising “producing” the oral drug dosage form by fused deposition modeling three-dimensional printing (i.e. FDM-3D printing).
Although the claims at issue are not identical, they are not patentably distinct from each other because the disclosure of U.S. Patent No. 10,350,822 expressly discloses FDM-3D printing, which is a type of 3D printing.
II. Claims 41 and 42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-15 of U.S. Patent No. 10,973,767.
Claims 100 and 101 are directed to a method of making an oral drug dosage containing a drug and having a “desired” pharmacokinetic release profile which has been designed by an arbitrary subject comprising 3D printing the dosage form.
The claims of U.S. Patent No. 10,973,767 disclose a method of making a tablet (i.e. an oral drug dosage form) having a pharmacokinetic release profile comprising at least two layers/portions each comprising a drug, the method comprising “producing” the oral drug dosage form by three-dimensional printing (i.e. 3D printing).
Although the claims at issue are not identical, they are not patentably distinct from each other because the dosage form of U.S. Patent No. 10,973,767 contains a drug, has the “desired” pharmacokinetic release profile of those who designed it, and was designed by at least one subject with the intention of producing the desired dosage form.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 41 and 42 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.
Claims 41 and 42 are really nothing but abstractions that are based on arbitrary and subjective choices and desires, which appear to not have actually been made or articulated, and undefined and unknown parameters that seem to depend, in part, on test results of tests that have not actually been performed yet. Applicant appears to be attempting to patent the basic, generic concept that its possible for one to design their own dosage form and then produce it by 3D printing. However, this basic concept does not constitute an actual, concrete invention under U.S. Patent law. Indeed, the metes and bounds of the actual dosage form are not only completely unknown, but are dependent on the whims and desires of a third party actor(s) who must decide things like e.g. the drug, the target PK profile, the amount of the drug in the dosage form, the amount of the drug that should be released and the rate of release, and the amount of the drug that should be absorbed, where the drug should be absorbed and at what rate, and the design of the dosage form, etc. In effect, the claims are not directed to Applicant’s invention that can be patented under U.S. Patent law, but merely to a broad and generic roadmap for a third party to possibly devise their own invention, which actual dosage form is yet to be determined in reality, but rather is based on the third party actors desires, choices, and test results. In effect, one of ordinary skill in the art cannot definitively ascertain the metes and bounds of the claimed subject matter, and indeed it would be impossible to do so since the claims are not directed to an actual, concrete invention, but rather to a roadmap for a third party to follow in an effort to devise their own invention.
***Applicant is advised that U.S. Patents are not awarded for a generic roadmap that one may use as a guide in devising their own method of making an oral dosage form by figuring out all the particulars of the dosage form to be made on their own. Rather, U.S. Patents are awarded for new, useful, and non-obvious methods of making an oral dosage form in final form in which Applicant has already figured out all the particulars and which are defined by a specific and concrete set of requisite active steps to be performed by the hand of man for making a concrete and properly defined dosage form.
Claim Rejections - 35 USC § 102(a)(1)
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 41 and 42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khaled et al. (Int J Pharm. 2014; 461: 105-111).
The elected subject matter is directed to a method of making an oral drug dosage form containing a drug and having a “desired” pharmacokinetic release profile comprising “producing” the oral drug dosage form by three-dimensional printing (3D printing).
Khaled et al. disclose a method of making an oral drug dosage form having a “desired” pharmacokinetic release profile comprising an immediate-release portion comprising the drug (e.g. guaifenesin) and an extended-release portion comprising the drug, the method comprising “producing” the oral drug dosage form by extrusion with three-dimensional printing.
Therefore, Khaled et al. anticipate the instantly claimed subject matter.
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID BROWE/Primary Examiner, Art Unit 1617
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