DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This office action is responsive to the amendment filed on December 6, 2024. As directed by the amendment: no claims have been amended, claims 1-92 have been canceled, and new claims 93-103 have been added. Thus, claims 93-103 are presently pending in the application.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because:
it includes the form and legal phraseology often used in patent claims (Line 4 recites the claim terminology “comprising” in line 4 and is written as one long sentence with several clauses, mimicking the form of a claim, rather than a narrative summary).
Correction is required. See MPEP § 608.01(b).
Claim Objections
Claim 93 is objected to because of the following informalities:
In claim 93, line 1, “the posterior region” should read -- a
In claim 93, line 3 “a nasal cavity” should read -- the.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
A “substance supply unit operable to deliver the powdered substance through the nosepiece” in claim 93, interpreted according to the specification at page 6, paragraphs 4-5, and what is shown in Figs. 2-3 (and equivalents thereof). The claim includes the generic placeholder “unit” and the function recited is delivering the powdered substance through the nosepiece. The preceding “substance supply” term further recites the function of supplying the substance rather than a structural modifier. The later recited limitation “the substance supply unit contains a powdered sumatriptan substance” is not considered sufficient structure for performing the function of supplying the substance/delivering the substance through the nosepiece, but rather is a further recited function of the substance supplying unit. However, the limitation is considered broadly to cover any device that can contain a powdered drug and cause or facilitate its delivery to a nosepiece, as is known in the art of nasal drug delivery devices, rather than being limited to the exact structure of the delivery device of Figs. 2 and 3.
A “substance containing unit containing a powdered sumatriptan substance” in claim 98, interpreted according to the specification at page 6, paragraphs 5-6 and Figs. 2-3 as a container, such as a capsule (and equivalents thereof). The claim includes the generic placeholder “unit” and the function recited is “containing a powered sumatriptan substance”. The preceding “substance containing” term further recites the function of containing the substance rather than a structural modifier. The limitation “the substance supply unit contains a powdered sumatriptan substance” is not considered sufficient structure for performing the function of containing the substance. Thus, the claim language necessitates a 112, sixth paragraph interpretation. However, the substance containing unit limitation is considered broadly to cover any container that could contain a powdered drug, as is known in the art of pharmaceuticals, rather than strictly a capsule type container.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 93-97 and 103 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 pre-AIA the applicant regards as the invention.
Claim 93 ends with the limitation “and wherein the powdered substance.” in line 10 which is an incomplete phrase. It is unclear whether applicant intended to further limit the claim with additional features or structure, or if the phrase was added unintentionally. Examiner has interpreted the claim as though this phrase were deleted.
Claims 94-97 are rejected based on their dependency to rejected claim 93
Claim 103 ends with “. comprises carboxymethylcellulose.” After the end on the claim sentence. It is unclear whether applicant intended to further limit the claim with additional features or structure, or if the phrase was added unintentionally. Examiner has interpreted the claim as though this phrase were deleted.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 93-103 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 6, and 8 of U.S. Patent No. 10,722,667.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claim 93 is a broader version of the patented claim 1. Thus, all of the limitations of the instant claim 93 are included in the patented claim 1 and any infringement over the patented claim 1 would also infringe upon the instant claim 93.
The limitations of dependent claim 94 are included in the patented claim 2.
The limitations of dependent claim 95 are included in the patented claim 3.
The limitations of dependent claim 96 are included in the patented claim 6.
The limitations of dependent claim 97 are included in the patented claim 8.
The instant claim 98 is a broader version of the patented claim 1. Thus, all of the limitations of the instant claim 98 are included in the patented claim 1 and any infringement over the patented claim 1 would also infringe upon the instant claim 98.
The limitations of dependent claim 99 are included in the patented claim 2.
The limitations of dependent claim 100 are included in the patented claim 3.
The limitations of dependent claim 101 are included in the patented claim 5.
The limitations of dependent claim 102 are included in the patented claim 6.
The limitations of dependent claim 103 are included in the patented claim 8.
Allowable Subject Matter
Claims 93-103 would be allowable except for the 35 U.S.C. 112, second paragraph and Double Patenting rejections set forth in this office action. Applicant may amend or rewrite the claim(s) to overcome the 35 U.S.C. 112, second paragraph rejection(s). Applicant may file a terminal disclaimer or amend/rewrite the claim(s) to overcome the Double Patenting Rejections.
The following is a statement of reasons for the indication of allowable subject matter:
As to claim 93, Djupesland (US 2005/0072430), in view of Craig et al. (EP 0 490 689 A1), and further in view of Truong-Lee (US 2004/0042972) represents the closest prior art to the claimed invention.
Djupesland discloses a delivery device (Fig. 2, Fig. 3) for delivering a powdered substance to the posterior region of a nasal cavity of a subject (Fig. 3, paragraph [0105], around the posterior margin of the nasal septum; paragraph [0101], substance delivered can be a dry powder), the delivery device comprising: a nosepiece 17 for insertion into a nasal cavity of a subject (paragraph [0077]) through which the powdered substance is delivered to the posterior region of the nasal cavity of the subject (Fig. 3, paragraph [0105], around the posterior margin of the nasal septum; paragraph [0101], substance delivered can be a dry powder); and a substance supply unit 29 which is operable to deliver the powdered substance through the nosepiece (paragraph [0100]-[0101)), wherein the substance supply unit 29 contains the powdered substance.
Djupesland lacks detailed description as to the limitation that the powdered substance is sumatriptan. However, Craig teaches sumatriptan as a powdered substance delivered intranasally to treat migraines (page 2, In. 1-21, page 3, In. 2). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the nasal delivery device of Djupesland so that the powdered substance is sumatriptan as taught by Craig in order to provide a means to effectively treat a patient for migraine pain.
Djupesland further lacks detailed description as to the limitation that the powdered substance comprising a particle size distribution in which at least 10% of the particles are less than about 20 µm, at least 50% of the particles are less than about 50 µm, at least 50% of the particles are greater than about 30 µm and at least 90% of the particles are less than about 150 µm.
While Truong-Le teaches a variety of workable particle size ranges suitable for intranasal delivery of a powder (within 10-150 microns MMD, paragraph [0090]) and further teaches an example particle size distribution of 10% less than or equal to 9.5 µm, 50% less than or equal to 21.8 µm and 90% less than or equal to 108.9 µm, the prior art of record does not disclose, teach, or suggest that at least 50% of the particles are greater than about 30 µm.
Thus, claim 93 and its dependent claims 94-97 would be allowable over the prior art of record.
As to claim 98, Miller et al. (US 2004/0025876), in view of Truong-Lee (US 2004/0042972) represents the closest prior art to the claimed invention.
Miller discloses a substance containing unit (capsule) containing a powdered sumatriptan substance (paragraph [0002] describes a capsule having a dry powder formulation; paragraph [0043] discloses that the active agent can sumatriptan).
Miller lacks detailed description as to the limitation that the powdered sumatriptan substance comprises a particle size distribution in which at least 10% of the particles are less than about 20 um, at least 50% of the particles are less than about 50 um, at least 50% of the particles are greater than about 30um and at least 90% of the particles are less than about 150 um (Miller only discloses a mass median aerodynamic diameter (MMAD) between 0.5 to 20 um, paragraph [0008)).
While Truong-Le teaches a variety of workable particle size ranges suitable for intranasal delivery of a powder (within 10-150 microns MMD, paragraph [0090]) and further teaches an example particle size distribution of 10% less than or equal to 9.5 microns, 50% less than or equal to 21.8 microns and 90% less than or equal to 108.9 microns, the prior art of record does not disclose, teach, or suggest that at least 50% of the particles are greater than about 30 um and that the powdered substance has an untapped bulk density of between about 0.3 g/ml and about 0.5 g/ml.
Thus, claim 98 and its dependent claims 99-103 would be allowable over the prior art of record.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Djupesland (US 2004/0112380) discloses a delivery device for delivering a substance to the nasal cavity.
Clay (US 6,413,499) discloses a nasal delivery device for delivering a substance to the posterior regions of the nasal cavity.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE L WOODWARD whose telephone number is (571)270-1479. The examiner can normally be reached on Monday - Friday 8:30 am - 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KENDRA CARTER can be reached on 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785
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