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 action is in response to papers filed April 27, 2026. Applicant’s reply to the restriction/election requirement of February 26, 2026 has been entered. Claims 1-22 are pending in the application.
Priority
Applicant’s claims for the benefit of prior-filed U.S. Provisional Patent Application Nos. 63/471,117, 63/627,892, and 63/627,890, filed June 5, 2023, February 1, 2024, and February 1, 2024, respectively, under 35 U.S.C. 119(e), are acknowledged.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-19, is acknowledged. Applicant’s elections of i) “tafamidis” as the species of tafamidis, ii) “hydroxypropyl-β-cyclodextrin” as the species of solubilizing agent, iii) “diluent” as the species of excipient, iv) “lactose” as the species of diluent, v) “sodium starch glycolate” as the species of disintegrant, and vi) “sodium stearyl fumarate” as the species of lubricant are all also acknowledged. The Examiner has determined that claims 1, 2, 8-13, 18, and 19 read on the elected subject matter.
The traversal is on the following grounds:
1. Groups I-III “are not unrelated inventions, but rather product, process-of-making, and process-of-use aspects of the same disclosed formulation platform…although related inventions may in some circumstances be distinct for restriction purposes”; that, regarding inventioins I and II, “the Office’s reliance on a different manufacturing route such as spray drying does not establish that the pending process-of-making claims, as claimed, are distinct”; that, regarding inventions I and III, “the Office’s cited example of another product such as vutrisiran is not the claimed product”; that, regarding inventions II and III, “the two process categories are not free-floating process inventions” since “the process for manufacturing the formulation” and the “process of administering the formulation” are both “linked to the same formulation and thus the same central inventive concept”; and that, moreover, “the Office…fails to provide the required serious burden explanation”.
2. Regarding the election of species requirement, “the specification presents a generic formulation concept, not a collection of disconnected inventions” and “the disclosure strongly indicates a common inventive concept”; that “the election requirement is especially problematic because the asserted species groups are not all species at the same conceptual level…instead, the Office Action subdivides one formulation into nested or cumulative ingredient categories”; that “requiring separate species elections…dissects a single formulation framework”; that “likewise, the solubilizing agent grouping is internally hierarchical”; that “the common technical effect across the disclosed embodiments further weighs against fragmented species practice here”; and that “the Office does not identify why each such grouping would require a materially different search”.
These grounds for traversal are not found persuasive for the following reasons:
1. Groups I, II, and III are directed to statutorily distinct classes of invention. The groups of inventions have further been shown to be independent and distinct for the reasons presented in the restriction requirement, e.g. the product as claimed can be made by another and materially different process. Applicant does not dispute these findings. Moreover, there would indeed be a serious search burden as the identified groups have acquired a separate status in the art in view of their different classification.
2. Applicant’s argument that e.g. the identified species simply represent different alternate embodiments of the same broader inventive concept is essentially the basis of election of species practice. Applicant is thus arguing in favor of election of species, not against it. Claim 1 provides that the formulation contains an excipient. But the claim provides a list of alternatives for the excipient, i.e. a diluent, a disintegrant, and a lubricant. The formulation need not contain all three. Instead, the formulation could contain e.g. a diluent, and not a disintegrant and not a lubricant. Alternatively, the formulation could contain a disintegrant and not a diluent and not a lubricant. These are mutually exclusive alternatives. This is the basis of election of species practice, and there is a search burden due to the mutually exclusive characteristics.
Accordingly, claims 3-7, 14-17, and 20-22 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected subject matter, there being no allowable generic or linking claim. The restriction/election requirement is still deemed proper, maintained, and is therefore made FINAL.
Applicant timely traversed the restriction (election) requirement in the reply filed on April 27, 2026. Claims 1, 2, 8-13, 18, and 19 are under examination.
Abstract
The abstract of the disclosure is objected to for the following reason:
i). The expression “a solid oral powder filled hard gelatin capsule” lacks proper punctuation. Applicant is advised to amend the expression to e.g. “a solid, oral, powder- filled, hard gelatin capsule”.
ii). The abstract appears to be redundant, twice disclosing that the composition contains tafamidis, a salt thereof, or a tafamidis co-crystal. Applicant is advised to polish up the presentation.
iii) The abstract should be a concise summary of the key technical aspects of the invention which are new to the art to which the invention pertains. If the invention is a composition, the abstract should recite the key requisite ingredients. In stark contrast to this requirement, the abstract merely informs the reader that the composition “involves use of standard dry blending ingredients”, which are not really defined and obviously not new. The abstract thus fails to adequately inform the reader of the key technical aspects of the invention which are new to the art.
iv). The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art. However, this is precisely what the abstract does, i.e. “improved dissolution profile”.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Drawings
The drawings are objected to because of the following:
1. In the drawings filed September 24, 2024, Figs 7-13 lack the x-axis and y-axis with proper tick marks at the values labeled.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1 and 18 are objected to because of the following:
i). In claim 1, there should be a comma between “oral” and “pharmaceutically”. There should be a hyphen between “powder” and “filled”.
ii). In claim 18, there should be a comma between “oral” and “pharmaceutically”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1, 8-13, 18, and 19 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.
Claims 1 and 19 stipulate that the formulation contains “an effective amount of” e.g. tafamidis. The claim never defines or discloses what the tafamidis should be effective against and in what context. Since the thing the tafamidis must be effective against is thus an undefined and unknown variable, the “effective amount” is thus an undefined and unknown variable. Moreover, what constitutes being “effective against” something appears to be an arbitrary and subjective criterion, which is also not defined by the claim. Hence, one of ordinary skill in the art cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claims 8-13 and 18 are indefinite for depending from an indefinite claim.
***Claim 2, which also depends from claim 1, is not indefinite since claim 2 properly defines the “effective amount”.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 8 and 18 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 8, which depends from claim 1, stipulates in a wherein clause that “the at least one solubilizing agent is selected from cyclodextrins, substituted cyclodextrin derivatives, and mixtures thereof”. However, claim 1 already provides for this very same limitation. Claim 8, therefore, does not further limit claim 1 from which it depends.
Claim 18, which depends from claim 1, stipulates in a wherein clause that “tafamidis or the pharmaceutically acceptable salt thereof has a D90 particle size of about 20 microns or less”. Claim 1, however, already provides for this limitation. Claim 18, therefore, does not further limit claim 1 from which it depends.
Claim Rejections - 35 USC § 102(a)(1) and 102(a)(2)
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 19 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Shanmugam et al. (U.S. Patent No. 11,523,993).
Claim 19 is directed to a hard gelatin capsule comprising tafamidis or a salt thereof; a solubilizing agent, and an excipient selected from a diluent, disintegrant and lubricant.
Shanmugam et al. disclose a hard gelatin capsule comprising tafamidis or a salt thereof; a solubilizing agent (e.g. cyclodextrin), and an excipient selected from a diluent, disintegrant and lubricant (see abstract; examples 13-15).
Therefore, Shanmugam et al. anticipate the claimed subject matter.
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.
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.
Claims 1, 2, 8-13, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Shanmugam et al. (U.S. Patent No. 11,523,993), in view of Matecic Musanic et al. (WIPO International Application Pub. No. WO 2023/091534).
Applicant Claims
Applicant’s elected subject matter is directed to a hard gelatin capsule comprising tafamidis having a D90 particle size of 20 microns or less, hydroxypropyl β-cyclodextrin, and lactose; wherein the tafamidis is present in the amount of 61 mg; wherein the hydroxypropyl β-cyclodextrin is present in the amount of 25-40 wt%; and wherein the lactose is present in the amount of 12-40 wt%.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Shanmugam et al. disclose a hard gelatin capsule comprising e.g. tafamidis, hydroxypropyl β-cyclodextrin, and lactose; wherein the tafamidis is present in the amount of 61 mg; wherein the hydroxypropyl β-cyclodextrin can be present in the amount of e.g. about 25-40 wt%; wherein the lactose can be present in the amount of e.g. about 12-40 wt%; and wherein the tafamidis can be in the form of particles smaller than mesh #30 (abstract; Col. 1, lines 7-10; Col. 2, lines 20-28, 37-53; Col. 3, lines 55-67; Col. 4, lines 5-6, 13-15, 22-24; Col. 5, lines 51-67; Col. 6, lines 1-27, 66-67; examples, particularly examples 13-15).
Matecic Musanic et al. disclose e.g. a hard gelatin capsule comprising a crystalline form of tafamidis with particle size of 5-10 µm and one or more excipients, wherein the excipients can include e.g. a solubilizer and lactose; wherein the small crystal particles of tafamidis are easy to process into a dosage form and exhibit increased dissolution and good water solubility (abstract; paragraphs 0017, 0029, 0031, 0033, 0075, 0078, 0091, 0093, 0107, 0108, 0113).
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Shanmugam et al. do not explicitly disclose that tafamidis has a D90 particle size of about 20 microns or less. This deficiency is cured by the teachings of Matecic Musanic et al.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application wads filed to combine the respective teachings of Shanmugam et al. and Matecic Musanic et al., outlined supra, to devise Applicant’s presently claimed composition.
Shanmugam et al. disclose a hard gelatin capsule comprising e.g. tafamidis, hydroxypropyl β-cyclodextrin, and lactose; wherein the tafamidis is present in the amount of 61 mg; wherein the tafamidis can be in the form of particles smaller than mesh #30. Since Matecic Musanic et al. disclose that e.g. a hard gelatin capsule comprising e.g. tafamidis, a soluibilizer, and lactose advantageously include tafamidis in crystal form with particle size of about 5-10 µm, wherein the small crystal particles of tafamidis are easy to process into a dosage form and exhibit increased dissolution and good water solubility; one of ordinary skill in the art would thus be motivated to employ small crystalline particles of tafamidis, with particle size of about 5-10 µm, in the Shanmugam et al. hard gelatin capsule, with the reasonable expectation that the resulting hard gelatin capsule will successfully exhibit increased tafamidis dissolution and improved tafamidis water solubility.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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/DAVID BROWE/Primary Examiner, Art Unit 1617
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