Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
This office action is in response to applicant’s reply filed on January 7, 2026.
Status of Claims
Amendment of claims 1 and 10 and cancellation of claim 7 is acknowledged.
Claims 1, 10, 14, 23-26, 30, 34, 36, 38, 43, 49, 52, 84-86, 191 and 197 are currently pending and are the subject of this office action.
Claims 86, 191 and 197 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 4, 2025.
Claim 85 was further withdrawn since it does not encompass the elected species.
Claims 1, 10, 14, 23-26, 30, 34, 36, 38, 43, 49, 52 and 84 are under examination.
Priority
The present application is a 371 of PCT/US2021/032881 filed on 05/18/2021 which claims priority to provisional application No. 63/026,550 filed on 05/18/2020.
Rejections and/or Objections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Rejections and/or Objections) or newly applied (New Rejections and/or Objections, Necessitated by Amendment or New Rejections and/or Objections not Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Responses to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.
Claim Rejections - 35 USC § 102 (Modified Rejection Necessitated by Amendment).
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 7, 10, 14, 26, 30, 38, 49 and 52 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Injac et. al. (US 2011/0262497).
For claim 1, Injac teaches (see Table 8 example 8c) a pharmaceutical composition comprising:
(A) Ezetimibe (an active pharmaceutical ingredient),
(B) Calcium Silicate (a first absorbent),
(C) Prosolv TM (Silicified MCC) (a second absorbent), and
(D) Texapon K 12 TM (a surfactant).
All the remaining ingredients qualify as either: 1- an excipient and/or 2- a pharmaceutically acceptable polymer.
Injac is silent regarding the active pharmaceutical ingredient being absorbed on the first absorbent or the second absorbent. However, the above does not seem to add any structural limitation, but instead describes a property of the formulation anticipated by the prior art.
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the pharmaceutical formulation disclosed by Injac, which anticipates all the structural limitations of claim 1, does not possess the same material, structural and functional characteristics of the pharmaceutical composition claimed in claim 1 of the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the instantly claimed pharmaceutical composition is different from the pharmaceutical composition/s taught by the prior art and to establish patentable differences.
See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Regarding claim 10, Injac is silent regarding the absorbed active pharmaceutical ingredient causes the first absorbent or the second absorbent to form agglomeration. However, the above does not seem to add any structural limitation, but instead describes a property of the formulation anticipated by the prior art.
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the pharmaceutical formulation disclosed by Injac, which anticipates all the structural limitations of claim 10, does not possess the same material, structural and functional characteristics of the pharmaceutical composition claimed in claim 10 of the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the instantly claimed pharmaceutical composition is different from the pharmaceutical composition/s taught by the prior art and to establish patentable differences.
See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Regarding claim 14, Injac does not teach that the active pharmaceutical ingredient, the first absorbent and the second absorbent are homogenously mixed.
However, according to MPEP 2113: “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
“The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983)”.
In the instant case, the prior art teaches compositions comprising the same components as the instant claims: active ingredient, first absorbent, second absorbent and a surfactant. As stated by Applicant, the prior art does not teach the process of homogenously mixing the active ingredient, the first absorbent and the second absorbent. However, Applicant has not provided any evidence that the composition of the prior art does not have the same physical characteristics as the instant composition.
Apparently, the product resulting from the instant process is similar or identical to the composition disclosed by the prior art (Injac et. al.), so as mentioned above, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983)”.
For claim 26, Injac teaches that the first absorbent is Calcium silicate.
For claim 30, Injac teaches that the pharmaceutical composition comprises 7.6% of calcium silicate (10 mg / 131.5 mg x 100), which anticipates the instantly claimed range (2.5% to about 45%).
For claim 38, Injac teaches that the pharmaceutical composition comprises 11.4% (15.0 mg / 131.5 mg x 100) of Prosolv (the second absorbent), which anticipates the instantly claimed range (2.5% to about 45%).
For claim 49, Injac teaches that the pharmaceutical composition comprises 7.6% of surfactant Texapon K 12 (10 mg / 131.5 mg x 100), which anticipates the instantly claimed range (0.5% to about 20%).
For claim 52, Injac teaches the presence of other excipients like: crospovidone.
Response to Applicant’s arguments related to the above rejection
Applicant's arguments have been fully considered but are not persuasive.
Applicant argues that:
C. Rejection under 35 U.S.C. 102(a)(1) in view of Injac et. al.
Examiner’s response:
First, Applicant tries to differentiate his invention with a functional limitation: “wherein the active pharmaceutical ingredient is absorbed on the first absorbent or the second absorbent”. However, there is no explanation in the prior art, nor in the instant specification on which active ingredients and absorbents qualify for this attribute. As, such, and unless Applicant can prove the contrary, it is fair to assume that the active ingredient Ezetimibe will be absorbed on the first absorbent (Calcium Silicate) and/or the second absorbent (Silicified MCC).
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the pharmaceutical formulation disclosed by Injac, which anticipates all the structural limitations of claim 1, does not possess the same material, structural and functional characteristics of the pharmaceutical composition claimed in claim 1 of the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the instantly claimed pharmaceutical composition is different from the pharmaceutical composition/s taught by the prior art and to establish patentable differences.
See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Second, as stated in the above 102 rejection, all the other components of the Injac formulation in Table 8c are either excipients and/or pharmaceutically acceptable polymers (see specification paragraphs [0076] through [0091]).
Claim Rejections - 35 USC § 103 (Maintained Rejection).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 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.
1) Claim(s) 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Injac et. al. (US 2011/0262497).
Injac teaches all the limitations of claims 23-25, except for the percentage range of the active ingredient
However, Injac teaches that the percentage amount of the active ingredient (Ezetimibe) in formulation 8c is 7.6% (10 mg / 131.5 mg x 100; 131.5 mg is the total amount of the internal components of formulation 8c) which is close to the claimed ranges.
MPEP 2144.05 states: “A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.).”
All this will result in the practice of claims 23-25 with a reasonable explanation of success.
2) Claim(s) 34 and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Injac et. al. (US 2011/0262497) in view of McCarty (US 2016/0256415).
Injac teaches all the limitations of claims 34 and 36, except for the second absorbent being silica. However, McCarty teaches that Prosolv is an absorbent like silica (see [0072]).
Before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to substitute one functional equivalence (any absorbent like Prosolv) for another (silica) with an expectation of success, since the prior art establishes that both function in similar manner.
Further, since porous silica is well known in the art, it will be further obvious to substitute Prosolv with a silica comprising pores, thus resulting in the practice of claims 34 and 36 with a reasonable expectation of success.
3) Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Injac et. al. (US 2011/0262497) in view of Van Quaquebeke et. al (US 2009/0221628).
Injac teaches all the limitations of claim 43, except for the surfactant being a polysorbate derivative. However, Van Quaquebeke teaches that polysorbate 80 (Tween 80) is a surfactant (a tension-active agent) like Texapon K 12.
Before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to substitute one functional equivalence (any surfactant like Texapon K 12) for another (a polysorbate like Tween 80) with an expectation of success, since the prior art establishes that both function in similar manner, thus resulting in the practice of claim 43 with a reasonable expectation of success.
Claim Objections
Claim 84 ais objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all the limitations of the base claim and any intervening claims.
Conclusion
No claims are allowed.
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the fee set forth in 37 CFR 1.17(p) on 05/10/10 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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 extension fee 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
January 9, 2026.