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
Claims 1-8 and 11-20 are presented for examination.
Applicant’s Amendment filed September 2, 2025 has been received and entered into the present application.
Claims 1-8 and 11-20 remain pending. Claims 1, 6, 12 and 15 are amended.
Applicant’s arguments, filed September 2, 2025, 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 Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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 of rejections and/or objections presently being applied to the instant application.
Requirement for Restriction/Election
Applicant is reminded of his election without traverse of the invention of Group I (original claims 1-17), directed to a pharmaceutical composition comprising azelastine, or a pharmaceutically acceptable salt of azelastine, methylcobalamin, and one or more pharmaceutically acceptable excipients, as stated in the reply filed April 3, 2025, which is still in effect over the claims.
Accordingly, claims 18-20 remain withdrawn from consideration pursuant to 37 C.F.R. §1.142(b) as being directed to a non-elected invention.
The claims that remain drawn to the elected invention are claims 1-8 and 11-17 and such claims are herein acted on the merits infra.
Claim Rejections - 35 USC § 112(b) (Pre-AIA Second Paragraph)
(New Grounds of Rejection)
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.
(1) Claims 6-8 and 11 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.
Applicant’s claim 6 recites “[t]he pharmaceutical composition of claim 2, wherein the pharmaceutically acceptable salt of azelastine is azelastine hydrochloride, and wherein the therapeutically effective daily dosage is selected for administration over 16 weeks to treat the Alzheimer’s disease [AD] or the Parkinson’s disease [PD] in the human patient”.
The “wherein” clause defining a step of selection and administration of the claimed pharmaceutical composition of azelastine and methylcobalamin renders the claim indefinite because the preamble of claim 6 is directed to a product, but the recited “wherein” clause recites apparent method steps of using the product (“wherein the therapeutically effective daily dosage is selected for administration over 16 weeks to treat the [AD] or the [PD] in the human patient”), which is improper. A single claim that claims both a product and apparent method steps of using said product is indefinite under 35 U.S.C. §112(b) (pre-AIA second paragraph). See Ex parte Lyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990) and MPEP §2173.05(p).
Clarification is required.
As claims 7-8 and 11 do not remedy this point of ambiguity, such claims must also be rejected on the same grounds applied to claim 6 above.
For these reasons, the claims fail to meet the tenor and express requirements of 35 U.S.C. §112(b) (pre-AIA second paragraph) and are, thus, properly rejected.
(2) Claims 15-16 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.
Applicant’s claim 15 recites “the pharmaceutical composition of claim 12, wherein the pharmaceutically acceptable salt of azelastine is azelastine hydrochloride, and wherein the therapeutically effective single daily dosage is selected for administration over 16 weeks to treat the [AD] or the [PD] in the human patient”.
The “wherein” clause defining a step of selection and administration of the claimed pharmaceutical composition of azelastine and methylcobalamin renders the claim indefinite because the preamble of claim 15 is directed to a product, but the recited “wherein” clause recites apparent method steps of using the product (“wherein the therapeutically effective single daily dosage is selected for administration over 16 weeks to treat the [AD] or the [PD] in the human patient”), which is improper. A single claim that claims both a product and apparent method steps of using said product is indefinite under 35 U.S.C. §112(b) (pre-AIA second paragraph). See Ex parte Lyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990) and MPEP §2173.05(p).
Clarification is required.
As claim 16 does not remedy this point of ambiguity, such claim must also be rejected on the same grounds applied to claim 15 above.
For these reasons, the claims fail to meet the tenor and express requirements of 35 U.S.C. §112(b) (pre-AIA second paragraph) and are, thus, properly rejected.
Interpretation of the Claims for Examination
Applicant amends claim 1 to recite “wherein the azelastine, or a pharmaceutically acceptable salt of azelastine, and methylcobalamin are together present in the pharmaceutical composition in a therapeutically effective daily dosage to treat [AD] or [PD] in a human patient”.
To the extent that Applicant recites “a therapeutically effective daily dosage”, the characterization of such dosage as “daily” – implying that it is a per day dosage – refers to an intended frequency of administration, which is a method step and not a further definition of the physical or structural attributes of the product itself. For this reason, the characterization of such dosage as a “daily dosage” does not further limit the claimed product.
As a result, the amounts of azelastine (or pharmaceutically acceptable salt thereof) and methylcobalamin are “present in the pharmaceutical composition” in an amount that is “therapeutically effective” to treat AD or PD. As claims 2-5 further define specific amounts of azelastine and/or methylcobalamin for incorporation into the composition, it is understood that such claims define amounts of azelastine and/or methylcobalamin that are “therapeutically effective” to treat AD or PD in order to constitute proper further limiting claims under 35 U.S.C. §112(d) (pre-AIA fourth paragraph).
Accordingly, a prior art reference that satisfies any one of the amounts of azelastine and/or methylcobalamin defined in claims 2-5 will be understood to satisfy this newly amended limitation of claim 1 to the extent that it is limiting to the product itself. It is not necessary that the prior art teach the combination of azelastine and methylcobalamin explicitly for the treatment of AD or PD, but rather only that the amounts meet Applicant’s amounts identified in the instant claims as functioning to treat AD or PD.
Applicant amends claim 6 to now recite “wherein the therapeutically effective daily dosage is selected for administration over 16 weeks to treat the [AD] or the [PD] in the human patient”.
Again, the characterization of such dosage as “daily” refers to an intended frequency of administration, which is a method step and not a further definition of the physical or structural attributes of the composition itself.
Applicant goes on to define a method step in which the dosage is “selected for administration over 16 weeks to treat the [AD] or the [PD] in the human patient”, which fails to further limit the product itself as this manner of use limitation fails to define any additional physical or structural attribute of the composition itself.
To the extent that the dosage is “therapeutically effective” to treat AD or PD, claims 7-8 and 11 further define specific amounts of azelastine and/or methylcobalamin, which are understood to constitute amounts “therapeutically effective” for the treatment of AD or PD in order to constitute proper further limiting claims under 35 U.S.C. §112(d) (pre-AIA fourth paragraph).
Accordingly, a prior art reference that satisfies any one of the amounts of azelastine and/or methylcobalamin defined in claims 7-8 and 11 will be understood to satisfy this newly amended limitation of claim 6 to the extent that it is limiting to the product itself. Again, it is not necessary that the prior art teach the combination of azelastine and methylcobalamin explicitly for the treatment of AD or PD, but rather only that the amounts meet Applicant’s amounts identified in the instant claims as functioning to treat AD or PD.
Applicant amends claim 12 to now recite “wherein the azelastine, or pharmaceutically acceptable salt of azelastine, and methylcobalamin are together present in the tablet in a therapeutically effective single daily dosage to treat [AD] or [PD] in a human patient”.
To the extent that Applicant recites a “therapeutically effective single daily dosage”, the characterization of such dosage as “single” and “daily” – implying that it is a single dosage per day – refers to an intended frequency of administration, which is a method step and not a further definition of the physical or structural attributes of the product itself. For this reason, the characterization of such dosage as a “single daily dosage” does not further limit the claimed product.
As a result, the amounts of azelastine (or pharmaceutically acceptable salt thereof) and methylcobalamin are “present in the tablet” in an amount that is “therapeutically effective” to treat AD or PD. As claims 13-14 define specific amounts of azelastine and methylcobalamin for incorporation into the composition, it is understood that such claims define amounts of azelastine and methylcobalamin that are “therapeutically effective” to treat AD or PD in order to constitute proper further limiting claims under 35 U.S.C. §112(d) (pre-AIA fourth paragraph).
Accordingly, a prior art reference that satisfies any one of the amounts of azelastine and/or methylcobalamin defined in claims 13-14 will be understood to satisfy this newly amended limitation of claim 12 to the extent that it is limiting to the product itself. As before, it is not necessary that the prior art teach the combination of azelastine and methylcobalamin explicitly to treat AD or PD, but rather only that the amounts meet Applicant’s amounts identified in the instant claims as functioning to treat AD or PD.
Such prior art would also meet the limitations of claim 17, which defines specific ratios of the quantity of azelastine to methylcobalamin, or methylcobalamin to azelastine. So long as the amounts applied to claim 17 are within those ranges defined by claims 13-14 as being “therapeutically effective” to treat AD, then such claim will also be properly rejected over the same prior art disclosure.
Applicant amends claim 15 to now recite “wherein the therapeutically effective daily dosage is selected for administration over 16 weeks to treat the [AD] or the [PD] in the human patient”.
Again, the characterization of such dosage as “single” and “daily” refers to an intended frequency of administration, which is a method step and not a further definition of the physical or structural attributes of the product itself.
Applicant goes on to define a method step in which the dosage is “selected for administration over 16 weeks to treat the [AD] or the [PD] in the human patient”, which fails to further limit the product itself as this manner of use limitation fails to define any additional physical or structural attribute of the composition itself.
To the extent that the dosage is “therapeutically effective” to treat AD or PD, claim 16 further defines specific amounts of azelastine and/or methylcobalamin, which are understood to constitute amounts that are “therapeutically effective” for the treatment of AD or PD in order to constitute proper further limiting claims under 35 U.S.C. §112(d) (pre-AIA fourth paragraph).
Accordingly, a prior art reference that satisfies the amounts of azelastine and methylcobalamin defined in claim 16 will be understood to satisfy this newly amended limitation of claim 15 to the extent that it is limiting to the product itself. Again, it is not necessary that the prior art teach the combination of azelastine and methylcobalamin explicitly for the treatment of AD or PD, but rather only that the amounts meet Applicant’s amounts identified in the instant claims as functioning to treat AD or PD.
Applicant’s attention is directed below to the pending prior art rejections in light of the interpretation of the amended claims as set forth above to direct examination.
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 (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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
(3) Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Rawas-Qalaji et al. (WO 2017/151723 A1; 2017, cited by Applicant on the 01/05/22 IDS) in view of Hatakeyama et al. (“Azelastine Hydrochloride on Behavioral and Psychological Symptoms and Activities of Daily Living in Dementia Patients”, Geriatr Gerontol Int, 2008; 8:59-61, cited by Applicant on the 01/05/22 IDS), each already of record, for the reasons of record set forth at p.4-7 of the previous Office Action dated April 30, 2025, of which said reasons are herein incorporated by reference.
Newly amended claim 1 recites “wherein the azelastine, or a pharmaceutically acceptable salt of azelastine, and methylcobalamin are together present in the pharmaceutical composition in a therapeutically effective daily dosage to treat [AD] or [PD] in a human patient”.
Here, the combined teachings of Rawas-Qalaji et al. in view of Hatakeyama et al. yield a pharmaceutical composition of azelastine hydrochloride with methylcobalamin in which the amounts of each component disclosed therein were effective to treat AD, thereby meeting this newly added limitation of Applicant’s instant claim 1.
Response to Applicant’s Arguments
In reply, Applicant traverses the rejection, stating that “Rawas-Qalaji does not disclose, teach or suggest a composition[s] including combined materials that together provide a therapeutically effective daily dosage to treat [AD] or [PD] in a human patient as recited in claim 1”, or “a composition formulated as a tablet with a coating to delay disintegration until in a gastrointestinal tract” (Remarks, p.7). Applicant contends that “[a]dding Hatakeyama to Rawas-Qalaji does not provide any combined art that would lead the skilled person to envision the claim[s] subject matter” (Remarks, p.7).
The arguments have been fully and carefully considered, but are not found persuasive.
Applicant’s position that Rawas-Qalaji et al. fails to teach a pharmaceutical composition of a combination of materials – in this case, azelastine with methylcobalamin – that provides a “therapeutically effective daily dosage” to treat AD or PD is not accepted because Rawas-Qalaji et al. was not applied alone, but rather in combination with Hatakeyama et al. While Rawas-Qalaji et al. is directed to a composition comprising methylcobalamin for the treatment of AD and does not explicitly teach the azelastine component of Applicant’s claimed composition, this was the purpose of citing to Hatakeyama et al. In the instant case, Hatakeyama et al. documents the therapeutic efficacy of azelastine hydrochloride in the treatment of AD – thus, suggesting its combination with Rawas-Qalaji’s methylcobalamin composition on the basis of this shared efficacy with a reasonable expectation of success. See MPEP §2144.06(I), which states that it is generally prima facie obvious to combine two or more compositions that have previously been used separately for the same therapeutic purpose.
In response to Applicant’s position that Rawas-Qalaji et al. fails to teach this combination of materials in “a composition formulated as a tablet with a coating to delay disintegration until in a gastrointestinal tract”, this position is unavailing for two reasons. Firstly, as explained above, Rawas-Qalaji et al. was not applied individually, but rather in combination with Hatakeyama et al. There would be no expectation that Rawas-Qalaji et al. alone teaches the specific methylcobalamin and azelastine combination instantly claimed. Secondly, only claim 1 is rejected and fails to recite any limitations directed to “a coating to delay disintegration until in a gastrointestinal tract”. If Applicant intends to reference the subject matter of claim 12 – which is directed to a coated tablet – then this would be additionally unavailing, as claim 12 is not under rejection here.
Applicant goes on to argue that “there is no guidance in the combined art regarding what amounts of the compounds, dosage schedule, etc. should be used in a product including two different compounds to treat [AD] or [PD] in a human patient” (Remarks, p.7).
The arguments have been fully and carefully considered, but are not found persuasive.
Applicant takes an unreasonably narrow view of the prior art teachings. Here, both Rawas-Qalaji et al. and Hatakeyama et al. describe specific amounts of methylcobalamin and azelastine hydrochloride, respectively, that were therapeutically efficacious to treat AD. The ordinarily skilled artisan, apprised of such teachings, would have had a reasonable expectation of success in combining methylcobalamin and azelastine hydrochloride into a single composition in these same amounts of each individual component described as therapeutically effective to treat AD. The assertion that there is no guidance in the prior art teachings as to how much of the individual components should be incorporated into the combined composition is unavailing because it fails to consider the full scope of the prior art teachings.
To the extent that Applicant argues the prior art teachings fail to provide guidance as to a “dosage schedule”, this is unavailing. The claims under examination are directed to a product, not a method, so limitations directed to use of the product – e.g., a dosing or administration schedule – do not further limit the physical or structural attributes of the product itself and, thus, are not patentably limiting thereto.
For these reasons supra, rejection of claim 1 is proper.
(4) Claims 1-8 and 11-17 are rejected under 35 U.S.C. 103 as being unpatentable over Dang et al. (U.S. Patent No. 8,071,073 B2; 2011, cited by Applicant on the 01/05/22 IDS) in view of Armstrong et al. (U.S. Patent No. 6,255,294 B1; 2001, cited by Applicant on the 01/05/22 IDS), each already of record, for the reasons of record set forth at p.7-11 of the previous Office Action dated April 30, 2025, of which said reasons are herein incorporated by reference.
Newly amended claim 1 now recites “wherein the azelastine, or a pharmaceutically acceptable salt of azelastine, and methylcobalamin are together present in the pharmaceutical composition in a therapeutically effective daily dosage to treat [AD] or [PD] in a human patient”.
As the prior art teachings of Dang in view of Armstrong teach amounts of azelastine and methylcobalamin that meet the limitations of Applicant’s claims 2-5, such amounts meet the newly added limitation of claim 1 that characterize these same amounts as being “therapeutically effective” to treat AD or PD in a human patient (see above, under the heading “Interpretation of the Claims for Examination”).
Newly amended claim 6 now recites “wherein the therapeutically effective daily dosage is selected for administration over 16 weeks to treat the [AD] or the [PD] in the human patient”.
As the prior art teachings of Dang in view of Armstrong teach amounts of azelastine and methylcobalamin that meet the limitations of Applicant’s claims 7-8 and 11, such amounts meet the newly added limitations of claim 6 that characterize these same amounts as being “therapeutically effective” to treat AD or PD in a human patient (see above, under the heading “Interpretation of the Claims for Examination”).
Newly amended claim 12 now recites “wherein the azelastine, or pharmaceutically acceptable salt of azelastine, and methylcobalamin are together present in the tablet in a therapeutically effective single daily dosage to treat [AD] or [PD] in a human patient”.
As the prior art teachings of Dang in view of Armstrong teach oral dosage forms, including tablets, that may be further coated with an enteric coating, with amounts of azelastine and methylcobalamin that meet the limitations of Applicant’s claims 13-14, such amounts meet the newly added limitations of claim 12 that characterize these same amounts as being “therapeutically effective” to treat AD or PD in a human patient (see above, under the heading “Interpretation of the Claims for Examination”).
Newly amended claim 15 now recites “wherein the therapeutically effective single daily dosage is selected for administration over 16 weeks to treat the [AD] or the [PD] in the human patient”.
As the prior art teachings of Dang in view of Armstrong teach oral dosage forms, including tablets, that may be further coated with an enteric coating, with amounts of azelastine and methylcobalamin that meet the limitations of Applicant’s claim 16, such amounts meet the newly added limitations of claim 15 that characterize these same amounts as being “therapeutically effective” to treat AD or PD in a human patient (see above, under the heading “Interpretation of the Claims for Examination”).
Response to Applicant’s Arguments
In reply, Applicant traverses the rejection, stating that “[t]here is no teaching or suggestion in Dang of a pharmaceutical composition comprising azelastine or a pharmaceutically acceptable salt of azelastine, methylcobalamin, and one or more pharmaceutically acceptable excipients” as defined in claim 1 or 12 (Remarks, p.8). Applicant contends that “[c]ombining Armstrong with Dang does not result in any combined art that teaches or suggests all elements of either amended claim 1 or amended claim 12” (Remarks, p.8).
The arguments have been fully and carefully considered, but are not found persuasive.
Applicant’s position that Dang et al. fails to teach a pharmaceutical composition of azelastine with methylcobalamin that provides a “therapeutically effective daily dosage” to treat AD or PD cannot be accepted for two reasons:
(i) Dang et al. was not applied alone, but rather in combination with Armstrong et al. Thus, while Dang et al. is directed to a composition comprising azelastine (or its hydrochloride salt) and does not explicitly teach the methylcobalamin component of the instantly claimed composition, this was the purpose of citing to Armstrong’s teachings. Here, Armstrong et al. documents the therapeutic efficacy of methylcobalamin in the treatment of allergic rhinitis – the same therapeutic purpose of Dang’s composition – thus, suggesting its combination with Dang’s azelastine composition on the basis of this shared efficacy with a reasonable expectation of success. Again, see MPEP §2144.06(I), which states that it is generally prima facie obvious to combine two or more compositions that have previously been used separately for the same therapeutic purpose; and
(ii) It is not necessary for the prior art to teach or suggest the same combination as Applicant to achieve the same advantage or results discovered by Applicant to find prima facie obviousness. MPEP §2144(IV). In other words, the prior art does not need to explicitly teach or suggest the same combination as Applicant for the same intended use as Applicant recites in the claim. So long as the prior art product meets every physical and structural limitation of the claim, then such prior art product will render the claimed product prima facie obvious and unpatentable, even if the reasoning behind such combination differs from Applicant’s rationale. The fact that Applicant has recognized another advantage – in this case, that this same combination may be therapeutically effective for the treatment of AD or PD – that flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. MPEP §2144(IV) and Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant is again reminded that the instant claims are directed to a product, not a method of use, so there is no requirement that the prior art suggest this same combination as Applicant claims for the identical therapeutic application for which Applicant intends to use it – the composition of matter is unpatentable so long as the prior art teachings render the identical combination prima facie obvious, even if the reasoning for doing so differs from Applicant’s reasoning.
Applicant contends that “the skilled person might expect to use a combined formulation of B12 and azelastine to treat allergic diseases in view of Dang and Armstrong”, but there is no “description or suggestion in the combined art” that would suggest this same combination to treat AD or PD as defined by instant claims 1 or 12 (Remarks, p.9).
The arguments have been fully and carefully considered, but are not found persuasive.
Again, the claimed invention under examination is directed to a product, not a method of use. A product is not patentably limited by its intended use, unless the intended use of the claimed invention results in a physical or structural difference between the claimed invention and the prior art. In the instant case, the combined teachings of Dang as modified by Armstrong teach a product that is physically and structurally identical to Applicant’s claimed product in components and amounts thereof, as well as the physical formulation. Though Applicant assigns a specific function to the amounts of the individual components (i.e., that they function to treat AD or PD in a human patient), the teachings of Dang and Armstrong suggest a pharmaceutical composition of the same components in the same amounts, albeit for a different use (in this case, allergic rhinitis). This different therapeutic use described by the prior art, however, does not change the fact that the prior art suggests a composition of the same physical and structural limitations (the same components in the same amounts in the same physical formulation) and, thus, must be capable of the intended use and function Applicant ascribes to this same composition.
Again, it is not necessary for the prior art to teach or suggest the same combination as Applicant to achieve the same advantage or results discovered by Applicant to find prima facie obviousness. MPEP §2144(IV). In other words, the prior art does not need to explicitly teach or suggest the same combination as Applicant for the same intended use as Applicant recites in the claim. So long as the prior art product meets every physical and structural limitation of the claim (which, in this case, it does), then such prior art product will render the claimed product prima facie obvious and unpatentable, even if the reasoning behind such combination differs from Applicant’s rationale. The fact that Applicant has recognized another advantage – in this case, that this same combination may be therapeutically effective for the treatment of AD or PD – that flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. MPEP §2144(IV) and Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
For these reasons supra, rejection of claims 1-8 and 11-17 is proper.
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.
(5) Claims 1-2, 6, 8, 12 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 11,318,144 B2, already of record, for the reasons of record set forth at p.12-14 of the previous Office Action dated April 30, 2025, of which said reasons are herein incorporated by reference.
Newly amended claim 1 now recites “wherein the azelastine, or a pharmaceutically acceptable salt of azelastine, and methylcobalamin are together present in the pharmaceutical composition in a therapeutically effective daily dosage to treat [AD] or [PD] in a human patient”.
Newly amended claim 6 now recites “wherein the therapeutically effective daily dosage is selected for administration over 16 weeks to treat the [AD] or the [PD] in the human patient”.
Newly amended claim 12 now recites “wherein the azelastine, or pharmaceutically acceptable salt of azelastine, and methylcobalamin are together present in the tablet in a therapeutically effective single daily dosage to treat [AD] or [PD] in a human patient”.
Newly amended claim 15 now recites “wherein the therapeutically effective single daily dosage is selected for administration over 16 weeks to treat the [AD] or the [PD] in the human patient”.
Claim 12 of the ‘144 patent states that the pharmaceutical composition recited therein is for administration to a patient having AD or PD, thereby indicating that such amounts are “therapeutically effective” to treat AD or PD in such patient (see above, under the heading “Interpretation of the Claims for Examination”).
(6) Claims 3-5, 7, 11, 13-14 and 16-17 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 11,318,144 B2,
as applied above to claims 1-2, 6, 8, 12 and 15,
further in view of Rawas-Qalaji et al. (WO 2017/151723 A1; 2017, cited by Applicant on the 01/05/22 IDS),
each already of record, for the reasons of record set forth at p.14-16 of the previous Office Action dated April 30, 2025, of which said reasons are herein incorporated by reference.
(7) Claims 1-8 and 11-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 10,639,314 B1 in view of Rawas-Qalaji et al. (WO 2017/151723 A1; 2017, cited by Applicant on the 01/05/22 IDS), each already of record, for the reasons of record set forth at p.16-21 of the previous Office Action dated April 30, 2025, of which said reasons are herein incorporated by reference.
Newly amended claim 1 now recites “wherein the azelastine, or a pharmaceutically acceptable salt of azelastine, and methylcobalamin are together present in the pharmaceutical composition in a therapeutically effective daily dosage to treat [AD] or [PD] in a human patient”.
Newly amended claim 6 now recites “wherein the therapeutically effective daily dosage is selected for administration over 16 weeks to treat the [AD] or the [PD] in the human patient”.
Newly amended claim 12 now recites “wherein the azelastine, or pharmaceutically acceptable salt of azelastine, and methylcobalamin are together present in the tablet in a therapeutically effective single daily dosage to treat [AD] or [PD] in a human patient”.
Newly amended claim 15 now recites “wherein the therapeutically effective single daily dosage is selected for administration over 16 weeks to treat the [AD] or the [PD] in the human patient”.
Claim 4 of the ‘314 patent as modified by the teachings of Rawas-Qalaji et al. suggests the resultant pharmaceutical composition to treat AD, thereby suggesting that such amounts are “therapeutically effective” to treat AD in such patient (see above, under the heading “Interpretation of the Claims for Examination”).
(8) Claims 1-8 and 11-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 and 9 of U.S. Patent No. 10,639,315 B1 in view of Rawas-Qalaji et al. (WO 2017/151723 A1; 2017, cited by Applicant on the 01/05/22 IDS), each already of record, for the reasons of record set forth at p.21-25 of the previous Office Action dated April 30, 2025, of which said reasons are herein incorporated by reference.
Newly amended claim 1 now recites “wherein the azelastine, or a pharmaceutically acceptable salt of azelastine, and methylcobalamin are together present in the pharmaceutical composition in a therapeutically effective daily dosage to treat [AD] or [PD] in a human patient”.
Newly amended claim 6 now recites “wherein the therapeutically effective daily dosage is selected for administration over 16 weeks to treat the [AD] or the [PD] in the human patient”.
Newly amended claim 12 now recites “wherein the azelastine, or pharmaceutically acceptable salt of azelastine, and methylcobalamin are together present in the tablet in a therapeutically effective single daily dosage to treat [AD] or [PD] in a human patient”.
Newly amended claim 15 now recites “wherein the therapeutically effective single daily dosage is selected for administration over 16 weeks to treat the [AD] or the [PD] in the human patient”.
Claims 7 and 9 of the ‘315 patent as modified by the teachings of Rawas-Qalaji et al. suggest the resultant pharmaceutical composition to treat AD, thereby suggesting that such amounts are “therapeutically effective” to treat AD in such patient (see above, under the heading “Interpretation of the Claims for Examination”).
(9) Claims 1-8 and 11-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10 and 12 of U.S. Patent No. 10,898,493 B2 in view of Rawas-Qalaji et al. (WO 2017/151723 A1; 2017, cited by Applicant on the 01/05/22 IDS), each already of record, for the reasons of record set forth at p.26-30 of the previous Office Action dated April 30, 2025, of which said reasons are herein incorporated by reference.
Newly amended claim 1 now recites “wherein the azelastine, or a pharmaceutically acceptable salt of azelastine, and methylcobalamin are together present in the pharmaceutical composition in a therapeutically effective daily dosage to treat [AD] or [PD] in a human patient”.
Newly amended claim 6 now recites “wherein the therapeutically effective daily dosage is selected for administration over 16 weeks to treat the [AD] or the [PD] in the human patient”.
Newly amended claim 12 now recites “wherein the azelastine, or pharmaceutically acceptable salt of azelastine, and methylcobalamin are together present in the tablet in a therapeutically effective single daily dosage to treat [AD] or [PD] in a human patient”.
Newly amended claim 15 now recites “wherein the therapeutically effective single daily dosage is selected for administration over 16 weeks to treat the [AD] or the [PD] in the human patient”.
Claims 10 and 12 of the ‘493 patent as modified by the teachings of Rawas-Qalaji et al. suggest the resultant pharmaceutical composition to treat AD, thereby suggesting that such amounts are “therapeutically effective” to treat AD in such patient (see above, under the heading “Interpretation of the Claims for Examination”).
(10) Claims 1-8 and 11-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10 and 12 of U.S. Patent No. 10,966,989 B2 in view of Rawas-Qalaji et al. (WO 2017/151723 A1; 2017, cited by Applicant on the 01/05/22 IDS), each already of record, for the reasons of record set forth at p.30-35 of the previous Office Action dated April 30, 2025, of which said reasons are herein incorporated by reference.
Newly amended claim 1 now recites “wherein the azelastine, or a pharmaceutically acceptable salt of azelastine, and methylcobalamin are together present in the pharmaceutical composition in a therapeutically effective daily dosage to treat [AD] or [PD] in a human patient”.
Newly amended claim 6 now recites “wherein the therapeutically effective daily dosage is selected for administration over 16 weeks to treat the [AD] or the [PD] in the human patient”.
Newly amended claim 12 now recites “wherein the azelastine, or pharmaceutically acceptable salt of azelastine, and methylcobalamin are together present in the tablet in a therapeutically effective single daily dosage to treat [AD] or [PD] in a human patient”.
Newly amended claim 15 now recites “wherein the therapeutically effective single daily dosage is selected for administration over 16 weeks to treat the [AD] or the [PD] in the human patient”.
Claims 10 and 12 of the ‘989 patent as modified by the teachings of Rawas-Qalaji et al. suggest the resultant pharmaceutical composition to treat AD, thereby suggesting that such amounts are “therapeutically effective” to treat AD in such patient (see above, under the heading “Interpretation of the Claims for Examination”).
(11) Claims 1-8 and 11-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 and 9 of U.S. Patent No. 11,389,458 B2 in view of Rawas-Qalaji et al. (WO 2017/151723 A1; 2017, cited by Applicant on the 01/05/22 IDS), each already of record, for the reasons of record set forth at p.35-39 of the previous Office Action dated April 30, 2025, of which said reasons are herein incorporated by reference.
Newly amended claim 1 now recites “wherein the azelastine, or a pharmaceutically acceptable salt of azelastine, and methylcobalamin are together present in the pharmaceutical composition in a therapeutically effective daily dosage to treat [AD] or [PD] in a human patient”.
Newly amended claim 6 now recites “wherein the therapeutically effective daily dosage is selected for administration over 16 weeks to treat the [AD] or the [PD] in the human patient”.
Newly amended claim 12 now recites “wherein the azelastine, or pharmaceutically acceptable salt of azelastine, and methylcobalamin are together present in the tablet in a therapeutically effective single daily dosage to treat [AD] or [PD] in a human patient”.
Newly amended claim 15 now recites “wherein the therapeutically effective single daily dosage is selected for administration over 16 weeks to treat the [AD] or the [PD] in the human patient”.
Claims 3 and 9 of the ‘458 patent as modified by the teachings of Rawas-Qalaji et al. suggest the resultant pharmaceutical composition to treat AD, thereby suggesting that such amounts are “therapeutically effective” to treat AD in such patient (see above, under the heading “Interpretation of the Claims for Examination”).
Response to Applicant’s Arguments
In reply, Applicant addresses the rejections collectively, stating that “Applicant will consider filing a terminal disclaimer upon the pending claims being allowable but for the double patenting rejections” (Remarks, p.9).
The arguments have been fully and carefully considered, but are not found persuasive.
Applicant’s response stating that he “will consider filing a terminal disclaimer upon the pending claims being allowable” fails to comply with the requirements of MPEP §804(I)(B)(1), which states that “[a] complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims, or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office Action”. Applicant’s response is, thus, technically non-responsive for failing to provide a complete response to the outstanding nonprovisional nonstatutory double patenting rejections as explicitly required by MPEP §804(I)(B)(1).
Nevertheless, Applicant is reminded that the instant claims are not in condition for allowance at this time in view of the pending substantive rejections above. Because Applicant has not filed a Terminal Disclaimer and/or persuasively distinguished (either through amendment and/or remark) the instant claims over the cited patent claims of the nonprovisional rejections, the rejections remain proper and are maintained.
For these reasons supra, rejection of claims 1-8 and 11-17 is proper.
Conclusion
Rejection of claims 1-8 and 11-17 is proper.
Claims 18-20 are withdrawn from consideration pursuant to 37 C.F.R. 1.142(b).
No claims of the present application are allowed.
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Leslie A. Royds Draper whose telephone number is (571)272-6096. The examiner can normally be reached Tuesday to Thursday (08:30 AM to 05:00 PM).
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/Leslie A. Royds Draper/Primary Examiner, Art Unit 1629
December 24, 2025