DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
This office action is in response to the reply filed 1/5/2026.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No. 60/801824, 60/801823 and 60/833319, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The above provisional applications do not support plasma profiles recited, therefore, claims 1-9, 11-14 and 16-20 will receive an effective filing date of 5/18/2007.
Response to Arguments
All of Applicants’ arguments filed 1/6/2026 have been fully considered.
In view of the cancelation of claim 17, the 112(b) rejection over this claim is withdrawn.
Applicant argues that the formulations Kavey include hard gelatin capsules and other formulations that are not orally administered or are not likely to provide the plasma concentration as defined by the claim. Nothing in Kavey suggests that the formulation should dissolve in the oral cavity and provide the claimed benefits.
This is not persuasive as the rejection is not based solely on Kavey, but is based on a combination of references. While Kavey teaches hard gelatin capsules, Kavey also teaches caplets which read on tablets. Furthermore, the rejection is based on a combination of references which make obvious the formulation of an orally disintegrating tablet of doxepin wherein the tablet disintegrates in the oral cavity. While the prior art is silent to the properties of plasma concentration and time to achieve sleep onset the instant specification teaches that when administering an rapidly orally disintegrating dosage form comprising 0.5-9mg of doxepin, the claimed blood plasma levels can be achieved [0146] and obtaining the target mean plasma concentration leads to more rapid drug and sleep onset [0011 and 0017]. The prior art makes obvious the performance of the claimed steps (i.e. administration) with the claimed composition to the claimed patient population, therefore the composition claimed and the composition of the prior art are expected to have the same properties, absent evidence to the contrary, as a composition and its properties are inseparable.
Applicant on page 7 disagrees with the Examiner’s allegation that “the prior art makes obvious… inseparable.” Applicant states “Applicant disagrees that the prior art suggests the claimed administration steps with the claimed composition to the claimed patient population.”
This is not persuasive as Applicant have not provided specific arguments to support their position. As discussed above and in the rejection below, the prior art makes obvious an orally disintegrating tablet comprising doxepin in the claimed amounts wherein the tablet has the same properties of fast dissolution in the oral cavity, same hardness, friability, orally disintegrating excipient, etc.
Applicant’s arguments regarding the DP rejections are not persuasive for the same reasons discussed above.
Maintained 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 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 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 through 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 negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1, 3-7, 9, 13 and 18-24 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kavey (US 6,211,229), Singh et al (WO 01/39749), CN1562013 and AU771949. All references are previously cited.
Kavey teaches methods for the treatment of transient or short term insomnia in patients which involves the administration of low dosages of doxepin (0.5-20mg) (Abs). In preferred embodiments, the doxepin is administered in amounts of 10mg or less (col. 2, lines 50-53), overlapping with instant claims 13 and 18. Kavey teaches that the method can be used for the treatment of onset insomnia (i.e. difficulty in falling asleep) (col. 1, lines 15-20 and col. 2, lines 60-65), thus it would have been prima facie obvious to administer the composition to a person suffering from onset insomnia and looking to fall asleep faster reading “treating sleep onset insomnia” of instant claim 23. Kavey teaches that treatment with doxepin relieves the onset insomnia (Example 1). While Kavey doesn’t teach providing a more rapid sleep onset as recited by instant claim 1, the prior art teaches treating difficulty falling sleep and treatment of this condition is expected to resulted in being able to fall asleep easier and therefore quicker, reading on more rapid sleep onset.
Absent an indication in the specification as to who makes up the patient population of needing more rapid sleep onset (i.e. someone with insomnia that needs to fall asleep faster, or anyone (i.e. someone not suffering from insomnia) needing to fall asleep quicker), then treatment of onset insomnia in a patient is seen as reading on the instant claims, as supported by the originally filed specification [0195].
However, Kavey does not teach the doxepin formulation to have an orally disintegrating excipient and the tablet to have a hardness of at least 6 Kp.
Singh teaches a fast dissolving pharmaceutical compositions in a solid dosage form with prolonged sweet taste which comprises a pharmaceutically active agent (0.1-99%), water-soluble sugar (5-95%) , non-sugar sweeteners (0.5-20%) (Abs and Pg. 4). It is noted that the water soluble sugar and non-sugar sweeteners read on the claimed orally disintegrating excipient and these are taught to be used in amounts which overlap with the claimed 15-99.9% as required by instant claim 3.
Singh does not teach the use of pH buffers, reading on instant claim 1.
Singh teaches the fast dissolving or disintegrating tablets can be administered without water. These tablets readily form a suspension or solution of the drug after mixing with the saliva, which is easily swallowed by patients. These are particularly suitable for children or aged parents who have difficulty chewing or swallowing and intact capsule/tablet. It is also suitable for those who are suffering from nausea or vomiting; those with upper gastrointestinal tract disease, situations where water is not available (Pg. 1-2).
Regarding claims 4-5 and 19: The tablets are taught to dissolve or disperse in the mouth within one minute requiring very little amounts of body fluids like saliva to produce a smooth solution or suspension of the drug with a prolonged sweet taste (Pg. 3), thus 100% of the dosage form is dissolved within one minute.
Suitable drugs for use in these formulations include anti-depressants, such as doxepin (Pg. 13).
Singh exemplifies tablets having hardness ranging from 1-5kg (equivalent to approx. 1-5Kp).
CN’013 teaches that rapidly disintegrating tablets, those that disintegrate within 30seconds in the oral cavity, allow the medicine to be quickly absorbed, which greatly improves the bioavailability, the drug rapidly taking effect in vivo. This increases patient compliance (Abs and page 2).
AU’949 teaches orally dispersible tablets with low friability. The tablets are taught to have a friability of less than 1%, preferably less than 0.5% wherein said tablet can be packaged with standard means and has the required and adequate hardness to enable it to be extracted from its bubble card wherein it is packed by perforating the seal thereof by pushing the tablet with substantially reduced risk of being broken when it is being extracted. The tablets are taught to dissolve in the mouth in contact with saliva in less than 30 seconds (Abs). AU’949 teaches the tablet to enable child safety standards to be met, as it can be kept in doubly protected blisters, that is to say blisters than can be torn and/or peeled open, and the risk of breakage when removing a tablet from packaging other than a non-peelable blister pack is substantially reduced (Pg. 5). The tablet is characterized in that a major amount of the lubricating agent which is used in its composition and which is in powder form, is distributed on the tablet surface and its friability is less than 1% (pg. 2). AU’949 teaches the tablets to have a hardness that is greater that 40N (equal to 4.08 Kp), preferably greater than 80N (equivalent to 8.16 Kp), this hardness is in all cases at least equal to the force needed to break the seal covering the blister in which the tablet is packed. and the tablets can be formulated to comprise anti-depressant active substance (Pg. 4).
It would have been prima facie obvious for one of ordinary skill in the art at the time the invention was made to formulate the composition of Kavey into a fast/rapid orally disintegrating tablet formulation of doxepin as taught by Singh having a hardness of at least 40N or preferably 80N (i.e. at least 4.08 or 8.16 Kp) and a friability of less than 1%. One of ordinary skill in the art would be motivated to create a fast disintegrating tablet as Singh teaches that these types of formulation have the advantage of being easy to swallow by patients and is able to be administered without the use of water and many more advantages taught above and CN’013 teaches that orally disintegrating tablets allow for the medicine to be quickly absorbed, which greatly improves the bioavailability and improves patient compliance. One of skill in the art would have been further motivated to formulate the tablet to have hardness of at least 4.08, preferably 8.16Kp and a friability of less than 1% because these are hardness that are suitable for use in orally disintegrating tablets wherein disintegration time is within one minute and the hardness and friability combined allow the tablet to be packaged with standard means and has the required and adequate hardness to enable it to be extracted from its bubble card wherein it is packed by perforating the seal thereof by pushing the tablet with substantially reduced risk of being broken when it is being extracted, this type of packaging also allows child safety. One of skill in the art would have also been motivated to optimize the hardness of the tablets as AU’949 teaches that the hardness is selected based on the force needed to break the seal covering the blister in which the tablet is packed. Absent evidence to the contrary, one of skill in the art would have reasonable expectation of success as Singh teaches that a suitable active agent for use in orally disintegrating tablets is doxepin, Kavey teaches that the use of doxepin in distinct administrable forms (solutions, capsules, etc.) is suitable (Col. 2, lines 65-67 to Col. 3, lines 1-3) and AU’949 teaches tablets with orally disintegrate within 30 seconds which can be formulated with anti-depressants.
Regarding claims 21-22 and 24: As discussed above, the prior art makes obvious the formulation of orally disintegrating tablets comprising doxepin.
While the prior art doesn’t teach “by transmucosal administration”, it is noted that the instant specification teaches that a preferred formulation for transmucosal administration is a fast disintegrating tablet that is adapted to disintegrate in the mouth of a subject in less than about 60 seconds , has a hardness of between 2-6 Kp [0127] and also teaches that fast disintegrating, oral, transmucosal formulations wherein the fast disintegrating formulations is an orally disintegrating tablet [0037]. Singh teaches an oral formulation which is compressed tablet with a hardness ranging from 1-5kg (equivalent to approx. 1-5Kp) which disintegrates in the mouth in less than 1 min and AU’949 teaches that hardness of at least 4.08 Kp are suitable and hardness is optimizable. Therefore, as the prior art makes obvious the structure taught by the instant specification to be capable of transmucosal administration, the formulation made obvious above is expected to provide transmucosal absorption absent factual evidence to the contrary.
Claim 1 recites “providing more rapid sleep onset…administration provides sleep onset within a period of less than…more rapid drug onset… without an orally disintegrating excipient” and claim 9 recite “wherein the method provides…”. Claim 13 recites “a method of providing an effective plasma concentration of doxepin…wherein the effective concentration is provided more…“administration provides sleep onset within a period of less than…”, Claims 6-7 and 20 recite “greater than … or nearly …is absorbed across the oral mucosa…,” claim 9 recites ”provides a therapeutically effective…induce sleep” and claim 23 recites “…provides a plasma concentration… administration provides sleep onset within a period of less than”
It is noted that these phrases recite properties of the claimed method and claimed composition and the instant specification teaches that when administering an rapidly orally disintegrating dosage form comprising 0.5-9mg of doxepin, the claimed blood plasma levels can be achieved [0146] and obtaining the target mean plasma concentration leads to more rapid drug and sleep onset [0011 and 0017]. The prior art makes obvious the performance of the claimed steps (i.e. administration) with the claimed composition to the claimed patient population, therefore the composition claimed and the composition of the prior art are expected to have the same properties, absent evidence to the contrary, as a composition and its properties are inseparable.
Maintained/Modified Double Patenting Rejections
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 3-7, 9, 13 and 17-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over the following patents in view of Kavey (US 6,211,229), Singh et al (WO 01/39749), CN1562013 and AU200029224:
Claims 1-14 of U.S. Patent No. 9,572,814;
Claims 1-13 of U.S. Patent No. 12,083,090;
Claims 1-11 of U.S. Patent No. 9,907,779;
Claims 1-9 of U.S Patent 11,013,712 (previously 13/612328);
Claims 1-20 of U.S Patent 10,548,871; and
Claims 1-20 of U.S Patent 11,096,920.
The Patents above describe the treatment of insomnia by the administration of doxepin in the claimed amounts, however, they do not teach the subject to be in need of a rapid sleep onset and they do not teach an orally fast disintegrating form of doxepin.
The teachings of Kavey are discussed above, in view of those teaching it would have been prima facie obvious to use the doxepin formulation of the Patents above to treat onset insomnia as discussed in the above rejections.
The teachings of Singh ‘749, CN’013 and AU’949 are discussed above and the instant claims are obvious for the same reasons as set forth above.
Claims 1, 3-7, 9, 13 and 17-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the following patents in view of Singh et al (WO 01/39749), CN1562013 and AU200029224:
Claims 21 and 24-29 of U.S. Application 17/408945
The applications above describe the treatment on insomnia by the administration of doxepin, in ranges overlapping with those instant claimed, in a patient suffering from difficulties in sleep onset, however, they do not teach an orally fast disintegrating form of doxepin.
The teachings of Singh ‘749, CN’013 and AU’949 are discussed above and the instant claims are obvious for the same reasons as set forth above.
Conclusion
No claims are allowable.
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 Jennifer A Berrios whose telephone number is (571)270-7679. The examiner can normally be reached on Monday-Thursday from 9am-4pm and Friday 9am-3:30pm.
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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613