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 .
Status of Claims
Claim 1 is pending and being examined on the merits herein.
Priority
This instant application 18974588, filed on 12/09/2024, is a CON of 18/961,095 and is a CON of PCT/US2023/023770, filed on 05/26/2023, which claims benefit of 63/425,928, filed on 11/16/2022 and claims benefit of 63/346,856, filed on 05/28/2022.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 description contains two different sized fonts: words in line 1 appear to be smaller than the rest of the words in claim. The font size should be consistent within the claim.
Claim 1 recites “each therapeutically effective dose”. Since in the claim “a therapeutically effective dose” is previously mentioned, the word “each” is suggested to replace with word “the”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 1 is 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.
Claim 1 recites ingredient percentages, e.g., 1% to 20%, 60% to 90%, 0.01% to 20%, while there is no definition of the calculation basis. It is unclear whether every percentage amount is based on the total dry powder composition amount, or it is based on the therapeutically effective dose amount, or it is individual ingredient concentration. The calculation basis of the weight percentages in the claim is interpreted as based upon total weight of the dry powder composition.
Claim 1 recites “having a particle size distribution defined as having a D90 …”. It is unclear whether the particle with the specified size distribution only defines the particle of nintedanib base or base with a salt form, or it is the particle size distribution of the overall dry powder composition. The particle size distribution is interpreted as only for nintedanib ingredient.
Claim 1 recites “or an effective daily dose of 0.05 to 40 mg”. There is insufficient antecedent basis for this limitation in the claim, because effective daily dose was not defined earlier in the claim. It is unclear whether this effective daily dose comprises the same components as therapeutically effective dose, or it comprises different components. The “effective daily dose” is interpreted as “intended use” of the dry powder composition, since it does not materially contribute to the composition.
Claim 1 recites “therapeutically and synergistically effective”, which is a relative term which renders the claim indefinite. The term “therapeutically and synergistically effective” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Although the specification provides a definition of the term “therapeutically and synergistically effective” means that the addition of the second or additional plurality of APIs provides a superior therapeutic effect compared to the nintedanib dose alone. The definition does not ascertain at what degree the therapeutic effect is superior. This phrase is interpreted as the outcome, property, or intended use of pirfenidone dry powder in combination with nintedanib dose, as it does not materially contribute to the dry powder composition.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Surber (US20150044288, 02/12/2015) in view of Holland (WO2016142201, 09/15/2016, PTO-892).
Surber throughout the reference teaches formulations comprising imatinib or salt, phenylaminopyrimidine derivative or salt, or other kinase inhibitor or salt (e.g., [0004]) for aerosol administration for prevention or treatment of various fibrotic, carcinogenic, vascular and viral infectious diseases including lung diseases (e.g., [0004]; Abstract) including pulmonary fibrosis, interstitial pneumonia, cystic fibrosis, and many others (e.g., [0153], corresponding to interstitial lung disease), via administering the compositions to a mammal by oral inhalation or intranasal inhalation (e.g., [0153]).
Surber teaches that kinase inhibitors for the composition include but not limited to, imatinib or salt, sorafenib or salt, nintedanib or salt, and many others (e.g., [0377]), and to treat pulmonary arterial hypertension, fibrotic disease, more specifically idiopathic pulmonary fibrosis and other pulmonary fibrotic disease, methods to administer other tyrosine kinase inhibitor or salt thereof can be co-administered in fixed combination, co-administered, administered sequentially, or co-prescribed with other drugs such as Esbriet, Pirespa or Pirfenex (trade names for pirfenidone) (e.g., [0237]).
Surber teaches that therapeutically effective dosage for the daily aerosol dose of imatinib or other tyrosine kinase inhibitor compound (e.g., nintedanib or salt), can be from about 0.000001 mg to about 3.3 mg /kg of body weight per dose (e.g., [0389]), and can be at a concentration of about 0.001% to about 100% by weight of the dry powder composition (e.g., Claim 14) (overlapping with 1% to 20% of nintedanib or salt in instant claim 1), with one or more carrier agents selected from the group consisting of lactose or mannitol at a concentration of about 0.001% to about 99.999% by weight of the weight of dry powder composition (e.g., Claim 14) (overlapping with 60% to 90% by weight of carrier agent in instant claim 1). Specifically, for dry powder inhaler, the tyrosine kinase inhibitor or salt compound can be dispersed and delivered in dosages from about 34 mcg to about 463 mg from a dry powder formulation (e.g., [0473]), or from about 0.001 mg to about 200 mg of tyrosine kinase inhibitor or salt in less than about 10 breaths, wherein the mass median diameter particle sizes are from about 1 to about 5 micron (e.g., Claim 15; Claim 17; [0021]), overlapping with effective dose ranges and particle size less than 5 um in instant claim 1.
Surber does not teach a force control agent at 0.01% to 20% by weight in the dry powder composition.
Holland throughout the refence teaches dry powder formulations comprising JAK3 kinase inhibitor with inhalation carriers or excipients such as lactose for treating respiratory diseases such as asthma and COPD (e.g., Pg. 1, Lines 5-12; Pg. 6, Lines 20-27).
Holland teaches compounds suitable for the inhalation composition include nintedanib, pirfenidone, etc. (e.g., Pg. 7, Lines 1-11), suitable inhalation carriers include crystalline sugars, and lactose is a preferred carrier (Pg. 7, Lines 27-29), and suitable force control agents which reduce the cohesion between the fine particles within the powder formulation for promoting deagglomeration when the powder is dispensed from the inhaler, e.g., metal stearate such as magnesium stearate, typically at about 1% w/w of the formulation (e.g., Pg. 7, bottom-Pg. 8 top), falling within the range of 0.01% to 20% of force control agent in instant claim. MPEP 2131.03.I states that "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). Holland teaches the particle size for the dry powder inhalation formulation is less than about 5 um and in further preferred in the range of about 1 um to about 5 um (e.g., Pg. 8, Lines 6-7) (overlapping to particle size distribution D90 less than about 5 um in instant claim).
It would have been prima facie obvious for a person with ordinary skills in the art prior to filing date to incorporate Holland teaching of implementation of force control agents into Surber’s dry powder formulation to arrive at current invention. Because Holland indicates the benefit of adding force agents to promote deagglomeration when powders being dispersed from the inhaler, it would have motivated artisans in the field to take advantage of this agent for reasonable expectation of success.
This renders obviousness as “use of known technique to improve similar devices (methods, or products) in the same way” or as “applying a known technique to a known device (method, or product) ready for improvement to yield predictable results”. See MPEP §2143. (I)(C) and (I)(D). Moreover, It is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this case, the weight amounts and dosage amounts overlap with those taught by prior art. The particle size is taught by Surber with median size less than 5 um, which is further confirmed by Holland to have preferred particle size between 1um to 5 um, which obviously would have a D90 less than 5 um, as instantly claimed. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Regarding the phrase “therapeutically and synergistically effective” in claim, it is interpreted as the outcome, property, or intended use of pirfenidone dry powder in combination with nintedanib dose, since it does not materially contribute to the dry powder composition, as discussed above. Because prior art teaches combination of nintedanib with pirfenidone with the specified amounts and particle size, this outcome, property, or intended use would necessarily present in prior art, or would be capable of being achieved.
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1, 4, 6, 9, 14, 23, 25, and 27 of copending Application No. 18961095 (reference application, hereafter App’095). Although the claims at issue are not identical, they are not patentably distinct from each other.
App’095 recites “a dry powder composition comprising a therapeutically effective dose
comprising 1 % to 20% by weight of nintedanib base or base within a salt form, having a particle size distribution defined as having a D90 less than about 5 µm, 60% to 90% by weight carrier agent, and 0.01 % to 20% by weight force control agent for aerosol delivery to lungs of the adult human by inhalation, wherein each therapeutically effective dose contains 0.05 to 10 mg of the nintedanib base or base within a salt form or an effective daily dose of 0.05 to 40 mg, to treat an interstitial lung disease” (Claim 1); further refines dosage of nintedanib base or base within a slat form in claims 4 and 6; further refines particle size in claims 9; nintedanib combination with pirfenidone in claim 14; particle size D90 in claim 23 and 25; recites a force control agent in claim 27. All these claims in App’095 read into instant claim 1.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claim 1 is not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DONGXIU ZHANG SPIERING whose telephone number is (703)756-4796. The examiner can normally be reached 7:30am-5:00pm (Except for Fridays).
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, SUE X. LIU can be reached at (571)272-5539. 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.
/DX.Z./ Examiner, Art Unit 1616
/SUE X LIU/ Supervisory Patent Examiner, Art Unit 1616
Prosecution Insights