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
Claims 1-13 and 16 are currently pending and those claims in a preliminary amendment filed on 01/09/2024 are acknowledged.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The two (2) information disclosure statements (IDS) submitted on 01/09/2024 and 10/21/2024 were filed before the mailing date of the instant first action on the merits. The submissions thereof are in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statements have been considered by the examiner, and signed and initialed copies are enclosed herewith.
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.
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 6-7 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.
Each of claims 6-7 recites “the lubricant” in line 2, but which lacks sufficient antecedent basis because base claim 1 does not require “a lubricant.”
Appropriate correction is requested.
Claim 3 is 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.
Base claim 1 recites “API in an amount of 0.1-40%” in line 3, and however its dependent claim 3 recites “the API is present in about 0.1 to 14%” in line 2. According to the specification, the term “about” means “±10% of the value referred to, and includes the value” (see instant publication at [0110]). Thus “about 0.1” of claim 3 embraces “0.09%” which is outside scope of instant claim 1 of “0.1”. Consequently, it may not be said that claim 3 furthers limits claim 1 in a proper manner.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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.
Claims 1-13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Pedersen et al. (US2020/000728A1, IDS of 01/09/2024) in view of Kitajima et al. (US8911779B2, IDS of 01/09/2024, citation is obtained from its corresponding US2012/0034301A1).
Applicant claims the below claim 1 filed on 01/09/2024:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from dosage medicine, pharmacy, physiology and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02) and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
Pedersen discloses pharmaceutical compositions comprising a peptide, such as a GLP-1 peptide which reads on the claimed active pharmaceutical ingredient (API), a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid which reads on the claimed SNAC, and a lubricant which reads on the lubricant of instant claim 5 (e.g., abstract, [0014], Table 1, and claims 1, 11 of prior art) in the form of oval-shaped tablet ([0322]); the SNAC is present in an amount of at least 90% (e.g., [0080], [0083], [0086] and [0092]) which overlaps the instant range of about 60 to 99.8% of instant claim 1 or about 75-99% of instant claim 2, and the API is present in an amount of 0.96-2.8% (e.g., A1 and A2 of Table 1) that overlaps the instant range of 0.1 to 40% of instant claim 1 or about 0.1 to 14% of instant claim 3. MPEP 2144.05: “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).” (instant claim 1 (in part), and instant claims 2-3 and 5); the API includes semaglutide (e.g., [0050] and first formula of claim 1 of prior art)(instant claim 4); the lubricant is present in an amount of less than 3% or 2-2.5% (e.g., [0105]-[0106]) which is within or overlaps the instant range of about 0.1-7%. See MPEP 2144.05 noted above (instant claim 6); the lubricant includes magnesium stearate (e.g., [0063] and [0099])(instant claim 7); the tablet composition further comprises pharmaceutical excipients (e.g., [0008], [0061]-[0062] and Tablet) (instant claim 8); and in embodiments, Tablet Samples of References A-A2 (e.g., [00323]-[00324]: Table 1) are provided as follows:
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For example, in the Reference A1 tablet, the GLP-1 agonist A1 (=semaglutide), SNAC, and magnesium stearate are present in about 2.8% (=3/105.6 mg), about 95% (=100/105.6 mg), and about 2.5% (=2.6/105.6 mg), respectively, that is within the claimed range of 0.1-14% (API), 84-97% (SNAC) and 1.5-3.5% (magnesium stearate), respectively(instant claim 9). MPEP 2144.05 above; the tablet as a unit dose has the weight of 50-1000mg which is within the claimed range of about 50 to 1200mg or about 290 to 390mg. MPEP 2144.05 above (instant claims 10-11); and the tablet composition is admininstered to treat diabetes and/or obesity (e.g., [0017]-[0018]) (instant claim 16).
However, Pedersen does not expressly teach the properties of tablet required by instant claims 1, 12 and 13. The deficiencies are cured by Kitajima.
Kitajima discloses a domed shape tablet has excellent shape retentivity with extremely low susceptibility to wearing and chipping (abstract); the tablet has the domed shape on each of the upper and lower horizontal surfaces of a cylindrical plate shape, wherein the domed shape satisfies the following requirements (a), (b) and (c) in the cross-sectional shape including the center line of the cylindrical plate shape: (a) each corner has an angle of 25 to 45°, (b) each corner has a horizontal length of 0.30- 1.0 mm, and (c) the cup has a depth of 0.6-1.2 mm (abstract and [0047]); the tablet has the length of 6-14 mm and the thickness of 4-6 mm ([0048] and Fig. 1). Each length and thickness of Kitajima corresponds to length L of major axis and length W of minor axis, respectively, as supported by the instant specification disclosing that the length L of tablet corresponds to the length of the major axis and the width W of the tablet corresponds to the length of the minor axis (see [0061] and Fig. 4 of the instant publication). Thus, the tablet length 6-14 mm overlaps the instant major axis range of about 10.0-14.0mm or about 11.7-16.5mm ([0048]) (instant claims 12-13, a) major axis)); the tablet thickness 4-6 mm or 4.2-5.6mm ([0048]) overlaps the instant minor axis range of about 5.1-8.5mm or about 6.0-10.0mm (instant claims 12-13, b) minor axis)); the cup depth is 0.6-1.2mm (abstract and [0047]) overlaps the instant range of about 0.7 to 1.5mm or about 0.8 to 1.8mm (instant claims 12-13, e) cup depth). Please note that each of instant claims 12-13 requires at least one of a)-i) and hence, when the prior art Kitajima teaches at least one, it reads on instant claims 12-13; the prior art teaches the length 6-14 mm of the tablet ([0048] and Fig. 1) that corresponds to the claimed width, and the thickness 4-6mm of the tablet ([0048] and Fig. 1) that also corresponds to the claimed height, and accordingly, a ratio of height (4-6mm) to width(6-14mm) of prior art is about 0.29-1 which overlaps the instant range of 0.9 or below (instant claim 1, (a) ratio). MPEP 2144.05 noted above; the thickness of the tablet is 4 to 6 mm ([0048] and Fig. 1) and the cup depth is 0.6 to 1.2mm (abstract and [0047]) and therefore, a ratio of height (4-6mm) to cup depth (0.6-1.2mm) is about 3.3-10 that overlaps the instant range of above 4.3. MPEP 2144.05 noted above (instant claim 1, (b) ratio); the tablet has the length of 6-14mm ([0048] and Fig. 1) corresponding to the claimed width and the radius 7-25mm of curvature (R) may correspond to the claimed minor major radius, and accordingly, a ratio of the radius (7-25mm) to length (6-14mm) is 0.5 to about 4.17 which overlaps the instant range of above 1.15 (instant claim 1, (c) ratio). MPEP 2144.05 noted above; the claimed index value is obtained by the below equation according to instant specification (see [0069] and Fig. 7 of instant publication): (cup width – distance (D))/cup width wherein the cup width corresponds to the width W of the tablet and distance (see [0064] of the instant publication). Here, for example, when the prior art teaches 6 mm length (=cup width) ([0048]), and 0.3 mm corner horizontal length ([0047] and Fig. 1: numeral no. 9), and therefore, the sum of both corner horizontal lengths are 0.6mm, and the cup distance between both corner horizontal lengths is 5.4mm (=6-0.6mm) (see Fig. 1). As a result, the index value is 0.1 (=(6-5.4)/6) which overlaps the instant range of 0.67 or below. MPEP 2144.05 noted above (instant claim 1, (d) index value).
It would have been obvious to modify the teachings of Pedersen with the oval shaped tablet requirements of Kitajima in order to enhance excellent shape retentivity with extremely low susceptibility to wearing and chipping of tablet as taught by Kitajima.
Accordingly, instant claims 1-13 and 16 are obvious over Pedersen in view of Kitajima.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined 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 combined references, especially in the absence of evidence to the contrary.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-13 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of copending application No. 19/071109 in view of Kitajima et al. (US 8,911,779B2, IDS of 01/09/2024, citation is obtained from its corresponding US2012/0034301A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets require overlapping amounts of SNAC, semaglutide that is GLP-1 peptide active agent, and lubricant magnesium stearate. The difference between them is that the claimed invention requires tablet properties of (a)-(d) and a)-i). The deficiencies are cured by Kitajima. Kitajima discloses the claimed properties with overlapping ranges as noted above. It would have been obvious to modify the teachings of copending ‘109 with the oval tablet requirements in order to enhance excellent shape retentivity with extremely low susceptibility to wearing and chipping as taught by Kitajima.
This is a provisional double patenting rejection since the conflicting claims have not yet been patented.
Claims 1-13 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of patent No. US1,1759,501B2 in view of Kitajima et al. (US 8,911,779B2, IDS of 01/09/2024, citation is obtained from its corresponding US2012/0034301A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets require overlapping amounts of SNAC, semaglutide that is GLP-1 peptide active agent, and lubricant magnesium stearate. The difference between them is that the claimed invention requires tablet properties of (a)-(d) and a)-i). The deficiencies are cured by Kitajima. Kitajima discloses the claimed properties with overlapping ranges as noted above. It would have been obvious to modify the teachings of patent ‘501 with the oval tablet requirements in order to enhance excellent shape retentivity with extremely low susceptibility to wearing and chipping as taught by Kitajima.
Claims 1-13 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of patent No. US1,1759,502B2 in view of Kitajima et al. (US 8,911,779B2, IDS of 01/09/2024, citation is obtained from its corresponding US2012/0034301A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets require overlapping amounts of SNAC, semaglutide that is GLP-1 peptide active agent, and lubricant magnesium stearate. The difference between them is that the claimed invention requires tablet properties of (a)-(d) and a)-i). The deficiencies are cured by Kitajima. Kitajima discloses the claimed properties with overlapping ranges as noted above. It would have been obvious to modify the teachings of patent ‘502 with the oval tablet requirements in order to enhance excellent shape retentivity with extremely low susceptibility to wearing and chipping as taught by Kitajima. Although patent ‘502 further requires a filler and a binder, the claimed invention uses “comprising” language which does not exclude introduction of those ingredients.
Claims 1-13 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of patent No. US1,1759,503B2, in view of Kitajima et al. (US 8,911,779B2, IDS of 01/09/2024, citation is obtained from its corresponding US2012/0034301A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets require overlapping amounts of SNAC, semaglutide that is GLP-1 peptide active agent, and lubricant magnesium stearate. The difference between them is that the claimed invention requires tablet properties of (a)-(d) and a)-i). The deficiencies are cured by Kitajima. Kitajima discloses the claimed properties with overlapping ranges as noted above. It would have been obvious to modify the teachings of patent ‘503 with the oval tablet requirements in order to enhance excellent shape retentivity with extremely low susceptibility to wearing and chipping as taught by Kitajima. Although patent ‘503 further requires a filler and a binder, the claimed invention uses “comprising” language which does not exclude introduction of those ingredients.
Conclusion
All examined claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/Primary Examiner, Art Unit 1613