DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions. 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.
Election/Restrictions
Applicant elected group II (method of making) with traverse in the reply filed on 25 April, 2024. The traversal was found unpersuasive, and the election/restriction requirement made final in the office action of 24 May, 2024.
Claims Status
Claims 1-10 and 12-20 are pending.
Claim 9 has been amended.
Claims 1-8 and 12-15 have been withdrawn due to an election/restriction requirement.
Withdrawn Rejections
The provisional rejection of claims 9-11 and 16-20 on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 18/228,706 (US 20240016897) in view of Kikuta et al (Drug Develop. Indust. Pharm. (1994) 20(3) p343-355) and Peter et al (Powder Technol. (2010) 199 p165-175) is hereby withdrawn due to the abandonment of the competing application.
The rejection of claims 9, 10 and 16-20 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite due to uncertainty as to what is excluded by “consists essentially of” is hereby withdrawn due to amendment.
Maintained/Modified Rejections
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 9, 10 and 16-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dhoot et al (US 20060078323) in view of Peter et al (Powder Technol. (2010) 199 p165-175).
Dhoot et al discuss microparticles for oral dosing of pharmaceuticals (paragraph 4). Example 7 describes 5g of SNAC mixed with 0.5g of magnesium stearate, which was then pressed into granules and coated with heparin (paragraph 275). Dhoot et al does not describe how long the material was mixed, leading to two scenarios:
The material was mixed for at least 5 min (20 min for claim 10). Under this scenario, Dhoot et al anticipates the claims.
The material was mixed for less than 5 min (20 min for claim 10). Under this scenario, Dhoot et al does not anticipate the claims, but the claims are obvious as equivalent to the same material mixed for the required amount of time but less efficiently.
Imagine that the 5.5 grams of material of example 7 of Dhoot et al are vigorously mixed by hand in a beaker with a glass rod. This will take a relatively short amount of time to completely mix. Now imagine a similar scenario, but on a multikilogram scale, using a trough, and the same glass rod. Under this situation, it will take much longer to achieve the same level of homogeneity as the first scenario, but the product will be the same. As evidenced by Kikuta et al, the degree or rate of lubricant distribution during the mixing operation depends on, among other things, the batch of magnesium stearate, the scale, and type of mixer used (p353, 2nd paragraph), supporting the equivalence of less efficient mixing being equivalent. Thus, the product is identical to the first scenario, and meets the claim limitations as to mixing time.
Alternatively, if a flow system with a continuous powder mixer is used (such as that of Vanarase et al, abstract) for mixing lubricant with other materials (p26, 2nd column, 2nd paragraph), mixing will occur from the time the system is turned on until the system is shut down, such as for maintenance or changing the material mixed for a different product. Note that the system of Vanarase et al worked on a scale of kg/hr (table 1, p28, 1st column, bottom of page); it seems unlikely that such a system will be run for only a few min at a time.
The difference between this reference and the claims is that this reference does not discuss roller compaction, and uses a different amount of lubricant.
Peter et al discuss a model for describing roller compaction (title). This is the best known dry granulation method that has the advantages of being a continuous process, requiring small GMP area, with a relatively large throughput, can handle powders that flow poorly or are heat or solvent sensitive, and requires low amounts of energy, making it the most economical granulation method (p165, 1st column, 1st paragraph). Note that this is in the context of tablets (p165, 2nd column, 1st paragraph). This reference discusses the advantages of roller compaction.
Therefore, it would be obvious to take the mixed material of Dhoot et al and subject it to roller compaction to form granules, as this is the most economical method of doing so. As this is a well known technique, an artisan in this field would attempt this process with a reasonable expectation of success.
Dhoot et al mix SNAC and lubricant, with the mixing time either conducted by the authors or an obvious variant. While the concentration is different than claimed, differences in concentration are not considered a patentable distinction absent secondary considerations (MPEP 2144.05(II)). While the reference discusses a subsequent step, at the time the mixing is completed, that step has not occurred, and just the claimed steps have, meeting the limitation of “consisting of.” Thus, the combination of references renders obvious claims 9 and 10.
Dhoot et al does not mention roller compacting, rendering obvious claim 17.
The lubricant is magnesium stearate, rendering obvious claims 18 and 20.
Peter et al discusses roller compacting. As the heparin is a coating on the particles, it is obvious to use the roller compacting before coating, as it grinds the particles, rendering obvious claims 16 and 19.
response to applicant’s arguments
Applicants argue that Dhoot et al have additional method steps, so violates the limitation of “consisting of” in the claims as amended.
Applicant's arguments filed 17 Dec, 2025 have been fully considered but they are not persuasive.
As noted in the rejection, Dhoot et al and Peter et al render obvious mixing SNAC and lubricant for at least 20 min followed by roller compacting. At that point in time, the steps in the prior art exactly match (consist of) applicant’s claimed invention.
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.
first rejection
Claims 9-11 and 16-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of copending Application No. 18/578,485 in view of Kikuta et al (Drug Develop. Indust. Pharm. (1994) 20(3) p343-355) and Peter et al (Powder Technol. (2010) 199 p165-175).
Competing claim 1 describes a method of manufacturing a solid pharmaceutical composition, comprising blending or mixing SNAC with a lubricant, optionally with an active pharmaceutical agent and other excipients, optionally followed by granulating the material.
The difference between the competing claims and the examined claims is that the competing claims does not specify the mixing time, nor does it describe the lubricant or roller compaction.
Kikuta et al discuss the effect of mixing time on the lubricating properties of magnesium stearate (title) using 0.1, 0.3, and 0.5% in their experiments (p346, 4th paragraph). The reference states that the degree or rate of lubricant distribution during the mixing operation depends on, among other things, the batch of magnesium stearate, the scale, and type of mixer used (p353, 2nd paragraph). This means that there are scenarios with inefficient mixing that will meet the time requirements of the examined claims merely to mix the material.
Peter et al discuss a model for describing roller compaction (title). This is the best known dry granulation method that has the advantages of being a continuous process, requiring small GMP area, with a relatively large throughput, can handle powders that flow poorly or are heat or solvent sensitive, and requires low amounts of energy, making it the most economical granulation method (p165, 1st column, 1st paragraph). Note that this is in the context of tablets (p165, 2nd column, 1st paragraph). This reference discusses the advantages of roller compaction.
Therefore, it would be obvious to use a roller compaction method to granulate the material, as this is the most economical method of granulation, as described by Peter et al. As this is a well known technique, an artisan in this field would attempt this process with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
response to applicant’s arguments
Applicant asks that this rejection be held in abeyance. However, until the rejection is overcome, it will remain valid.
second rejection
Claims 9-11, 16, 18, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30, 47, and 48 of copending Application No. 17/424,537 (US20220072493) in view of Kikuta et al (Drug Develop. Indust. Pharm. (1994) 20(3) p343-355).
Competing claim 30 describes a method of producing ribbons or granules of hydroxybenzoyl amino caprylate using a roller compactor. Competing claim 47 specifies that the caprylate is the sodium salt (i.e. SNAC), and there is a lubricant mixed in it before compaction. Competing claim 48 specifies that the lubricant is magnesium stearate.
The difference between the competing claims and the examined claims is that the competing claims does not specify the mixing time.
Kikuta et al discuss the effect of mixing time on the lubricating properties of magnesium stearate (title), using 0.1, 0.3, and 0.5% in their experiments (p346, 4th paragraph). The reference states that the degree or rate of lubricant distribution during the mixing operation depends on, among other things, the batch of magnesium stearate, the scale, and type of mixer used (p353, 2nd paragraph). This means that there are scenarios with inefficient mixing that will meet the time requirements of the examined claims merely to mix the material.
This is a provisional nonstatutory double patenting rejection.
response to applicant’s arguments
Applicant asks that this rejection be held in abeyance. However, until the rejection is overcome, it will remain valid.
third rejection
Claims 9-11 and 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 6 of U.S. Patent No. 10,335,369 in view of Hess et al (Europ. J. Pharmaceut. Sci. (2005) 25 p307-312).
Competing claim 1 is identical to examined claim 9, save that the competing claim does not specify the salt used. Competing claim 2 is almost identical with examined claim 10. Competing claim 3 specifies that the lubricant is at least 0.25% by weight, while competing claim 6 specifies that the lubricant is magnesium stearate.
The difference between the competing claims and the examined claims is that the competing claims do not specify the sodium salt of the permeation enhancer.
Hess et al look at the mechanism by which SNAC improves intestinal permeability (title). This reference uses the sodium salt of the material of the competing claims.
Therefore, it would be obvious to use the sodium salt of the material of the competing claims, as a simple substitution of one known element (the unspecified salt of the competing claims) with another (the sodium salt of Hess et al) yielding expected results (intestinal permeation). As this material is commonly used for this purpose, an artisan in this field would attempt this substitution with a reasonable expectation of success.
response to applicant’s arguments
Applicant asks that this rejection be held in abeyance. However, until the rejection is overcome, it will remain valid.
fourth rejection
Claims 9-11 and 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-9, and 12 of U.S. Patent No. 10,335,369 in view of Hess et al (Europ. J. Pharmaceut. Sci. (2005) 25 p307-312).
Competing claim 1 is identical to examined claim 9, save that the competing claim does not specify the salt used and does not list an optional roller compaction step. Competing claim 2 is almost identical with examined claim 10. Competing claim 3 specifies that the lubricant is at least 0.25% by weight, while competing claim 6 specifies that the lubricant is magnesium stearate. Competing claims 7-9 and 12 differ from competing claims 1-3 and 6 only in that a roller compaction step is required.
The difference between the competing claims and the examined claims is that the competing claims do not specify the sodium salt of the permeation enhancer.
Hess et al look at the mechanism by which SNAC improves intestinal permeability (title). This reference uses the sodium salt of the material of the competing claims.
Therefore, it would be obvious to use the sodium salt of the material of the competing claims, as a simple substitution of one known element (the unspecified salt of the competing claims) with another (the sodium salt of Hess et al) yielding expected results (intestinal permeation). As this material is commonly used for this purpose, an artisan in this field would attempt this substitution with a reasonable expectation of success.
response to applicant’s arguments
Applicant asks that this rejection be held in abeyance. However, until the rejection is overcome, it will remain valid.
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 FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658