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
The claim listing filed 23 May 2024 is pending. Claims 1-8 are being examined on the merits in this office action.
Priority
The present application claims status as a 371 (National Stage) of PCT/IN2023/050902 filed 03 October 2023, and claims priority under 119(a)-(d) to Republic of India Patent Application No. IN202241056675 filed 03 October 2022.
Receipt is acknowledged of certified copies of papers submitted under 35 USC 119(a)-(d) for Indian Application No. IN202241056675, which papers have been placed of record in the file.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 23 May 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statement is being considered by the examiner.
Claim Objections
Claims 2-8 are objected to because of the following informalities:
Claim 2 states “The stable injectable composition as claimed in claim 1; the said composition has pH in a range of from 7-10.”. For improved clarity, please amend the claim to say “The stable injectable composition according to claim 1, wherein the composition has a pH in a range of from 7-10.”.
Claim 3 states “The stable injectable composition as claimed in claim 1; the sodium is added during the manufacturing process stage of teduglutide.”. For improved clarity, please amend the claim to say “The stable injectable composition according to claim 1, wherein the sodium is added during the teduglutide manufacturing process.”.
Claim 4 states “The stable injectable composition as claimed in claim 1; further comprises one or more pharmaceutically acceptable excipient(s) such as buffers, preservatives, antioxidants, surfactants, stabilizer, tonicity agents, bulking agents.”. For improved clarity, please amend the claim to say “The stable injectable composition according to claim 1, wherein the composition further comprises one or more pharmaceutically acceptable excipients, where the excipients are buffers, preservatives, antioxidants, surfactants, stabilizer, tonicity agents, and/or bulking agents.”.
Claim 5 states “The stable injectable composition as claimed in claim 1; the said composition is prepared by combining teduglutide …”. For improved clarity, please amend the claim to say “The stable injectable composition according to claim 1, wherein the composition is prepared by combining teduglutide…”.
Claim 6 states “The stable injectable composition as claimed in claim 1; the said composition is in the form of powder for reconstitution and/or solution for injection.”. For improved clarity, please amend the claim to say “The stable injectable composition according to claim 1, wherein the composition is in the form of powder for reconstitution and/or solution for injection.”.
Claim 7 states “The stable injectable composition as claimed in claim 1; the said composition administered parenterally such as subcutaneous, intramuscular, intravenous injection.”. For improved clarity, please amend the claim to say “The stable injectable composition according to claim 1, wherein the composition is administered parenterally, where the administration is subcutaneous, intramuscular or intravenous injection.”.
Claim 8 states “The stable injectable composition as claimed in claim 1; used for treatment of gastrointestinal diseases or teduglutide sensitive disease or disorders.”. For improved clarity, please amend the claim to say “The stable injectable composition according claim 1, to be used for treatment of gastrointestinal diseases or teduglutide sensitive disease or disorders.”.
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.
Claims 4 and 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.
Claim 4 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.
Regarding claim 4, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 7 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.
Regarding claim 7, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
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)(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.
Claims 1, 3-8 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mohan et al., hereafter “Mohan” (WO 2018/142363 A1).
Regarding claim 1, Mohan teaches a stable GLP-2 peptide injectable composition, comprising GLP-2 peptide, wherein the GLP-2 peptide could be teduglutide (pg. 1, “The present invention relates to a stable, ready-to-use pharmaceutical preparation of GLP-2 analogue for parenteral administration …”; pg. 5, “The pharmaceutical preparation includes different GLP-2 analogues such as teduglutide or its pharmaceutically acceptable salt…”). Mohan also teaches that a single dose preparation comprises 0.54 mg/ml of combined monobasic sodium phosphate monohydrate and dibasic sodium phosphate heptahydrate and that the complete dosage is 24.1 mg/ml, 0.54 mg/ml is 2.24% of 24.1 mg/ml (pg. 18, “Manufacturing process: (i) required quantity of water for injection is taken in a vessel, to this required quantity of mannitol is added and stirred to dissolve. (ii) sodium phosphate buffers, L-histidine, polysorbate- 80 or poloxamer, monothioglycerol are added to the above solution followed by the addition of teduglutide and stir to dissolve followed by pH adjustment of the solution…”; see example 2, page 18).
Regarding claim 3, Mohan teaches sodium being added during the manufacturing of teduglutide (pg. 18, “(ii) sodium phosphate buffers, L-histidine, polysorbate- 80 or poloxamer, monothioglycerol are added to the above solution followed by the addition of teduglutide and stir to dissolve followed by pH adjustment of the solution…”). Regarding claim 3, wherein sodium being added during the manufacturing of teduglutide, it is noted that Mohan teaches the composition having teduglutide and sodium. This renders claim 3 a “product-by-process” claim. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. See MPEP §2112.01 (I) (“Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).”).
"[E]ven 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) See MPEP §2113.
Regarding claim 4, Mohan teaches that the composition comprising one or more pharmaceutically acceptable excipients (pgs. 17-19, See examples 1-3 showing the presence of pharmaceutically acceptable excipients; pg. 7, “In another aspect of the invention, there is provided a multiple dose pen injection device or a single dose injection comprising a reservoir of a sterile solution comprising teduglutide, tonicity adjusting agents, buffering agent, vehicle or carrier, antioxidant, stabilizer…”).
Regarding claim 6, Mohan teaches that the composition is in the form of a powder that is then reconstituted (pg. 19, See example 3; pg. 1, “Teduglutide is commercially available as GATTEX® (teduglutide [rDNA origin]), single use glass vial which is a lyophilized formulation available as 5mg/vial sterile, white lyophilized powder for reconstitution with 0.5mL Sterile water for Injection”; pg. 10, “According to one embodiment of the present invention, the sterile solution of teduglutide can be prepared by the following process which involves: … (iv) the step (iii) solution is optionally lyophilized in a dual chamber prefilled syringe to obtain a lyophilized cake or powder and water for injection is filled in other chamber. The above described process is carried out at controlled temperature and during the process the nitrogen purging is carried out at required steps.”).
Regarding claim 7, Mohan teaches the composition being administered via subcutaneous injection (pg. 3, “The invention also relates to a stable ready-to-use pharmaceutical preparation of GLP-2 analogue for parenteral administration in a multiple dose or a single dose injection … wherein the device is adapted to subcutaneously inject a single daily dose or deliver multiple doses, while the solution remains sterile.”). Additionally, claim 7 is directed towards intended use of the claimed invention. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art composition is capable of performing the intended use, then it meets the claim. The composition as described in Mohan is administered in the same administration method described in the independent claim 1; thus it is interpreted as being sufficient for administration via injection as described in the instant claim.
Regarding claim 8, regarding the limitation “used for treatment of gastrointestinal diseases or teduglutide sensitive disease or disorders”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art composition is capable of performing the intended use, then it meets the claim. The composition as described in Mohan is administered in the same administration method described in the independent claim 1; thus it is interpreted as being sufficient for treatment of gastrointestinal diseases or teduglutide sensitive disease or disorders as described in the instant claim.
Claim Rejections - 35 USC § 102/103
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)(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.
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.
Claim 5 is rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as being obvious over Mohan et al., hereafter “Mohan” (WO 2018/142363 A1).
Regarding claim 5, Mohan teaches that a single dose preparation comprises 0.54 mg/ml of combined monobasic sodium phosphate monohydrate and dibasic sodium phosphate heptahydrate and that the complete dosage is 24.1 mg/ml, 0.54 mg/ml is 2.24% of 24.1 mg/ml (pg. 18, See example 2; pg. 18, “Manufacturing process: (i) required quantity of water for injection is taken in a vessel, to this required quantity of mannitol is added and stirred to dissolve. (ii) sodium phosphate buffers, L-histidine, polysorbate- 80 or poloxamer, monothioglycerol are added to the above solution followed by the addition of teduglutide and stir to dissolve followed by pH adjustment of the solution…”; see example 2, page 18). Mohan also teaches that a h[Gly2]GLP-2 lyophilized formulation can comprise a phosphate buffer in an amount necessary to maintain the pH of the product (pg. 1, “… the h[Gly2]GLP-2 lyophilized formulation comprising in the reconstituted product: phosphate buffer in an amount necessary to maintain the pH of the reconstituted product pH…”).
With respect to the limitation that teaches the composition being prepared by combining teduglutide comprising sodium in an amount of 2% w/w, a person of ordinary skill in the art would reasonably modify the amount of sodium, as taught in Mohan, to fall into the claimed range because routine optimization of the sodium is to be considered to be within the level of ordinary skill in the art due to Mohan teaching that the composition also comprises sodium. See MPEP §2144 (II). (“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mohan’s teachings because one of ordinary skill in the art would be inclined to believe that with standard routine optimization, one of ordinary skill in the art would be motivated to test the minimum amount of sodium needed to improve the stability of the composition due to Mohan teaching that a phosphate buffer amount can be changed to maintain the pH of the reconstituted product pH.
Regarding claim 5, wherein teduglutide, comprising sodium in an amount 2% w/w, is combined with one or more pharmaceutically acceptable excipients, it is noted that Mohan teaches the composition having teduglutide, sodium, and one or more pharmaceutically acceptable excipients (See examples 1-3). This renders claim 5 a “product-by-process” claim. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. See MPEP §2112.01 (I) (“Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).”).
"[E]ven 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) See MPEP §2113.
Claim Rejections - 35 USC § 103
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Mohan et al., hereafter “Mohan” (WO 2018/142363 A1).
Regarding claim 2, Mohan teaches a stable GLP-2 peptide injectable composition, comprising GLP-2 peptide, wherein the GLP-2 peptide could be teduglutide (pg. 1, “The present invention relates to a stable, ready-to-use pharmaceutical preparation of GLP-2 analogue for parenteral administration …”; pg. 5, “The pharmaceutical preparation includes different GLP-2 analogues such as teduglutide or its pharmaceutically acceptable salt…”). Mohan also teaches that a single dose preparation comprises 0.54 mg/ml of combined monobasic sodium phosphate monohydrate and dibasic sodium phosphate heptahydrate and that the complete dosage is 24.1 mg/ml, 0.54 mg/ml is 2.24% of 24.1 mg/ml (pg. 18, “Manufacturing process: (i) required quantity of water for injection is taken in a vessel, to this required quantity of mannitol is added and stirred to dissolve. (ii) sodium phosphate buffers, L-histidine, polysorbate- 80 or poloxamer, monothioglycerol are added to the above solution followed by the addition of teduglutide and stir to dissolve followed by pH adjustment of the solution…”; see example 2, page 18). Mohan also teaches the composition having a pH in the range of 2-9, with an example showing that the pH of the preparation is between 7 and 8.5 (pg. 7, “Further, according to the present invention, the pH of the said pharmaceutical preparation is in the range of 2 to 9. For example, pH of the preparation is between about 7 to about 8.5.”).
Mohan does not expressly teach the pH being in the range of 7-10.
It would be obvious to one of ordinary skill in the art before the effective filing date to reasonably believe that the pH of the composition as taught by Mohan could fall within the pH range as taught in the instant claim, due to the two pH ranges overlapping. See 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range."). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range).”; “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.")”).
One of ordinary skill in the art would have combined the two teachings and had a reasonable expectation of success because "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.".
Status of Claims
Claims 2-8 are objected to. Claims 4 and 7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Claims 1, 3-4 and 6-8 are rejected under 35 U.S.C. 102(a)(2). Claim 5 is rejected under 35 U.S.C. 102(a)(2)/35 U.S.C. 103. Claim 2 is rejected under 35 U.S.C. 103.
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Daliyah M. Brown whose telephone number is (571)272-0136. The examiner can normally be reached Monday-Thursday 9:00 am - 4:30 pm.
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/Daliyah M. Brown/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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