DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 24 February 2026 has been entered.
Applicant’s arguments, filed 24 February 2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 presently being applied to the instant application.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 22-26 and 29-46 are rejected under 35 U.S.C. 103 as being unpatentable over US 2004/0219146 A1 (Schenk, 11/04/2004).
Schenk discloses administration of alum as an enhancer for administration of polypeptide compositions (i.e. claimed pharmaceutical formulation) to prevent or treat Alzheimer's disease, which is characterized by amyloid deposits, such as Aβ (i.e. β-amyloid peptide) in a patient. An effective dosage may comprise an antibody that specifically binds to the amyloid deposit or a component thereof to the patient; or a polypeptide comprising an active fragment of Aβ that induces an immune response to Aβ in the patient. ([0006], [0012], [0013]). To prepare the dosage with alum, Aβ peptide in PBS (phosphate-buffered saline, i.e. excipient) is added to Alhydrogel® (2% aqueous aluminum hydroxide gel, i.e. alum) to reach desired concentrations of Aβ peptide in 2mg alum in a final dose volume of 200 µl (i.e. 0.2 ml) as a suspension ([0298]), or as AN1792 (i.e. 42 amino acid long Aβ, or Aβ42 as noted by [0192] of Schenk) in PBS added to Alhydrogel® to reach desired concentrations of AN1792 in 5mg alum in a final dose volume of 250 µl (i.e. 0.25 ml) ([0280]). Schenk further discloses a number of diagnostic tests are available for identifying individuals with Alzheimer’s disease (AD). These include measurement of the CSF (cerebrospinal fluid) tau and Aβ42 levels, as well as diagnosis by Alzheimer’s disease and Related Disorders Association (ADRDA) criteria, which is used to define early- to mid-Alzheimer’s disease using a Mini-Mental State Exam (MMSE) (¶¶ [0128], [0335]).
Together these would provide a method for treating dementia associated with beta-amyloid deposition as instantly claimed. The prior art is not anticipatory insofar as alum is selected from a list of alternative adjuvant choices in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP 2143(I)(A).
With regards to instantly claimed “aluminum oxyhydroxide”, as noted by page 14 of the instant Specification, Alhydrogel® 2%, Al2O3, or alum, is an aluminum oxyhydroxide wet gel suspension. Thus, the alum, or aluminum hydroxide gel, disclosed by Schenk, meets the limitation of the aluminum oxyhydroxide as claimed.
Regarding the claimed amounts of aluminum oxyhydroxide of claims 22, 30 and 31, the claimed ranges would’ve been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding claims 29, 38-39, and 41, Schenk further discloses wherein administration of the dosages may be done subcutaneously, in multiple dosages over a period of at least six months ([0009]). Intervals between dosages may be monthly (i.e. claimed at least once monthly). Dosage and frequency of administration can vary depending on whether treatment is prophylactic or therapeutic. Some patients continue to receive treatment for the rest of their lives ([0133]).
Regarding claim 39, although Schenk does not explicitly disclose a location of administration, it would appear to have taken no more than the relative skills of one of ordinary skill in the art to have determined a suitable administration location based on known and effective injection sites.
Regarding claim 41, since Schenk discloses administering subcutaneously, administration by an injection device would flow from such teaching.
Regarding claims 33-36, Schenk does not explicitly disclose the claimed characteristics of Alhydrogel®, such as particle size distribution, anion content, or heavy metal content. However, as noted by pp. 12-14 of the instant Specification, “the Alhydrogel® (i.e. aluminum oxyhydroxide) preparation is devoid of anions, such as sulphates, nitrates, or chlorides and has a specified heavy metal content of less than 20 ppm. The suspension of aluminum oxyhydroxide has a particle size distribution between 2 µm and approximately 10 µm.” Accordingly, since the formulation of Schenk comprises substantially the same components (i.e. Alhydrogel® as the claimed aluminum oxyhydroxide suspension) in about the same amounts, one of ordinary skill in the art would reasonably conclude the formulation of Schenk to reasonably possess the same properties as the claimed invention, such as a particle size distribution between about 2 µm and about 10 µm, be substantially devoid of sulfate, nitrate, or chloride anions, or have a heavy metal content of less than about 20 ppm.
Regarding claim 37, as discussed above, Schenk discloses wherein the formula comprises peptide in PBS added to Alhydrogel®. As noted by Phosphate-buffered saline (Wikipedia, IDS Reference, retrieved May 29, 2017), PBS is isotonic. Therefore, one of ordinary skill in the art would reasonably conclude the formulation of Schenk to be isotonic.
Regarding claim 40, as discussed above, Schenk discloses administering dosages for at least six months, and some patients continue to receive treatment for the rest of their lives. Accordingly, the claimed duration (i.e. at least two years) would have been obvious to one of ordinary skill in the art since it overlaps with the range of the prior art. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding claim 42 reciting a dose volume, the claimed ranges (i.e. from about 0.1 to about 10ml) would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art (i.e. 0.2 or 0.25 ml). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding claim 43, the transitional phrase “consists essentially of” limits the scope of a claim to the specified materials or steps “and those that do not materially affect the basic and novel characteristic(s) of the claimed invention” (See MPEP 2111.03(III)). Applicant has not made clear in the instant specification or instant claims any component such as compounds, adjuvants, or additives wherein the addition of such component would constitute a material change in the basic and novel characteristics of the claimed invention or cause a deleterious effect to the claimed invention. Therefore, for the purposes of searching for and applying prior art under 35 U.S.C. 103, "consisting essentially of" will be construed as equivalent to "comprising." Accordingly, the limitations of claim 43 have been addressed when addressing the limitations of claims 30 and 32 as discussed previously. Therefore, claim 43 is rejected based on the same reasons set forth previously in rejecting claims 30 and 32.
Regarding claim 44, Schenk further discloses wherein adjuvants may be administered separately, before, concurrently with, or after administration of the therapeutic agent ([0137]). Accordingly, it would have been obvious to one of ordinary skill in the art to have administered the alum (e.g., Alhydrogel®) separately, thus without a second active pharmaceutical ingredient.
Regarding claim 45, as discussed above, Schenk discloses treating or preventing Alzheimer’s Disease, which is characterized by beta-amyloid deposits. Similarly, as noted by p. 1, ¶ 2 of the instant Specification, Alzheimer’s disease is a type of dementia associated with amyloid deposition; as noted by p. 1, ¶ 3 of the Specification, Alzheimer’s disease is the most prominent form of beta-amyloidoses, characterized by beta-amyloid deposition.
Regarding claim 46, as discussed above, Schenk discloses wherein the formula comprises peptide in PBS added to Alhydrogel®.
Response to Arguments
Applicants assert that Schenk specifically discloses aluminum hydroxide, phosphate, and sulfates salts. Schenk does not disclose aluminum oxyhydroxide as instantly claimed. Therefore, Schenk provides no teaching or suggestion to use aluminum oxyhydroxide in the treatment of dementia associated with beta-amyloid deposition. As Schenk provides no guidance regarding at least one claim feature, the skilled artisan would not have been motivated to arrive at the instant claims with a reasonable expectation of success.
The Examiner does not find the Applicant’s assertions to be persuasive. Schenk discloses using Alhydrogel®, and also refers to Alhydrogel® as alum or aluminum hydroxide. As noted by p. 9, second paragraph from the bottom of the instant Specification, Alhydrogel® is known as aluminum oxyhydroxide. Page 10, line 2 of the Specification further notes aluminum hydroxide is used interchangeably with aluminum oxyhydroxide. Accordingly, one of ordinary skill in the art would reasonably expect the same Alhydrogel®, comprising aluminum hydroxide, to read on the instantly claimed aluminum oxyhydroxide. As such, Applicant’s assertions are unpersuasive.
Claims 39 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over US 2004/0219146 A1 (Schenk, 11/04/2004) in view of “How to administer a subcutaneous injection (Rushing, 06/2004).
The disclosures of Schenk is discussed above. While Schenk is believed to support a finding of obviousness, purely arguendo, for the purposes of complete prosecution, and for the purposes of this ground of rejection only, Schenk will be interpreted as though it does not explicitly disclose a location for subcutaneous administration.
However, Rushing discloses appropriate injection sites for subcutaneous injections include the outer aspect of the upper arm (¶ 4). Administration may be done by determining an appropriate needle size and angle (¶ 5, Fig. 2 on left).
Accordingly, it would have been obvious to one of ordinary skill in the art to have administered the dosage of Schenk in the upper arm, since it is a known and effective location suitable for subcutaneous delivery as taught by Rushing.
Similarly, regarding claim 41, Schenk will be interpreted as though it does not explicitly disclose utilizing a specific device for administering the subcutaneous dosages.
However, as discussed above, Rushing discloses administering subcutaneous injections with a syringe and needle (i.e. claimed injection device). Accordingly, it would have been obvious to one of ordinary skill in the art to have utilized an injection device such as a syringe and needle, to administer the dosage of Schenk, since it is a known and effective device for delivering subcutaneous injections as taught by Rushing.
Response to Arguments
Applicant does not present specific arguments with regards to Schenk and Rushing.
Since the Examiner has discussed Schenk above, this rejection is maintained.
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.
Claims 22-44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,857,568. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite a more specific embodiment having a narrower range for the amount of aluminum salt (i.e. about 1.0 mg to about 3.0 mg). Moreover, Claim 6 of the patented claims disclose wherein mild cognitive impairment (MCI) may be early-stage Alzheimer’s disease and thus read on the instant claims.
Claims 22-44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,147,873. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite a more specific embodiment having the same range for the amount of aluminum salt (i.e. about 1.2 mg to about 5.0 mg) for treating Alzheimer’s disease and thus read on the instant claims.
Claims 22-44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,646,565 and claims 1-12 of U.S. Patent No. 10,478,454. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite more specific embodiments (i.e. to a human patient or specific species of aluminum oxyhydroxide) having a similar range for the amount of aluminum salt (i.e. at least 1.2 mg) for treating Alzheimer’s disease and thus read on the instant claims.
Claims 22-44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,065,273. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim 2 of the patented claims recite reducing severity of Alzheimer’s disease, with an amount of aluminum salt exceeding a prescribed amount in the US general biological products standards of 21 C.F.R. 610.15, as of Apr. 2013 (i.e. 1.25 mg) and thus read on the instant claims.
Response to Arguments
Applicant does not present specific arguments with regards to the pending Nonstatutory Double Patenting Rejections, other than that 18/514,612 has been abandoned.
The Examiner has withdrawn the Nonstatutory Double Patenting rejection of copending Application 18/514,612. In regard to the other rejections, in the absence of a Terminal Disclaimer, the rejections still apply and have been maintained.
Conclusion
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612