-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 .
Priority
This application is a continuation of 16/765,627 filed on 05/20/2020, which is a 371 of PCT/EP2018/082178 filed on 11/22/2018, and claims foreign priority in GB1719464.8 filed on 11/23/2017.
Claim Status
Claims 1-30 are pending and examined.
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 2-6, 8, 9, 11, 14-19, 22, and 28-30 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 2 recites the limitation "excipient" in line 3. There is insufficient antecedent basis for this limitation in the claim. The claim provides antecedent basis for “the at least one excipient”.
Claim 3 recites the limitation "the excipient" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites "the excipient is a glycol or glycol derivative, a polyhydric alcohol, or an ester and/or ether thereof” and claim 14 recites "the excipient is a glycol or glycol derivative, a polyhydric alcohol, or an ester and/or ether thereof”. The claims are indefinite because the scope of the at least one excipient is not clear. The claims could be interpreted to mean that "an ester and/or ether thereof” is intended to modify glycol, glycol derivative, and a polyhydric alcohol; or that "an ester and/or ether thereof” is intended to only modify the polyhydric alcohol because the phrase occurs immediately after polyhydric alcohol. The claims are further indefinite because it is not clear which elements in the list are alternatives from which the at least one excipient is selected. The list recites two occurrences of "or" and one "and/or". It is recommended to amend the list and make it clear which elements are modified by "ester and/or ether thereof”, and it is recommended to list the alternatives where each alternative is separated with a comma and the last two separated with a comma and "or". For example, "the excipient is A, B, or C".
Claim 4 recites the limitation "the excipient" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the excipient" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the excipient" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "excipient" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claims 9 and 22 recite "wherein the formulation is stable at room temperature". The claims are indefinite because the scope of temperature is unknown. The specification does not define the term. Grounds of rejection may be obviated by replacing "room temperature" with "at a temperature from l 5°C to 25°C”. Support for the temperature range is present in at least paragraph 0021 of the published application. The claims are further indefinite because it is unknown what property of the formulation is “stable” at room temperature and it is unknown what formulations are encompassed by the claim.
Claim 11 recites the limitation "excipient" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the excipient" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the excipient" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the excipient" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the excipient" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "excipient" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "excipient" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites the limitation "excipient" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 29 recites the limitation "excipient" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 30 recites the limitation "excipient" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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)(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.
Claim 26 is rejected under 35 U.S.C. 102(a)(l) as being anticipated by Mylius (Justus
Liebigs Analen Der Chemie, Volume 587, Published January 7, 1954, pages 1-15 - English
language translation appended thereto – of record in IDS dated 06/01/2023).
The claim encompasses a formulation made from a eutectic mixture comprising active
compounds paeonol or isomer thereof and apocynin or isomer thereof.
Mylius disclosed a melting point diagram of 3-oxy-4-methoxy-actophenone and 4-oxy-3-
methoxy-acetophenone at various weight ratios of the two components (Figure 1 on page 14 of
the translation). It is apparent from the diagram that Mylius formed a eutectic mixture of the two
when 3-oxy-4-methoxy-actophenone was present in a concentration of 60 wt.% and 4-oxy-3-
methoxy-acetophenone was present in a concentration of 40 wt. % because the melting point of
the mixture at 60/40 weight ratio was at about 72°C. The melting point of the 60/40 mixture was
the lowest melting point on the diagram and it is lower than the melting point of each of the two
components individually. 3-Oxy-4-methoxy-actophenone is an isomer of paeonol and 4-oxy-3-
methoxy-acetophenone is an isomer of apocynin. The claimed invention is anticipated.
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.
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.
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.
Claims 1-9, 11, 23-25, 28, and 29 are rejected under 35 USC 103 as being obvious over Larkins et al. (GB2424833 A, published 11/10/2006 – of record in IDS dated 06/01/2023) in view of Gullapalli et al. (International Journal of Pharmaceutics 496 (2015) 219-239 – of record in IDS dated 06/01/2023).
The claims encompass a liquid formulation comprising active compounds 2-hydroxy-4-
methoxyacetophenone (paeonol) or isomer thereof and 4-hydroxy-3-methoxyacetophenone
(apocynin) or isomer thereof wherein the ratio by weight of paeonol or isomer thereof to
apocynin or isomer thereof is from 3 :2 to 9: 1; and at least one excipient wherein the ratio by
weight of total active compounds to the at least one excipient is from 2:3 to 19:1.
Larkins teaches compositions comprising apocynin and paeonol and methods of using to
treat inflammatory disease (Abstract). A preferred composition comprises apocynin and paeonol
in a weight ratio between about 1 to 100 and about 100 to 1, and preferably between about 1:2 to
1: 10 (page 7 lines 3-8). The composition further comprises pharmaceutically conventional
carriers, diluents, flavorings, emulsifiers, and stabilizers (page 8 lines 16-19). A daily dose of the
composition may be provided as a single capsule, tablet, or other solid liquid form known to the
skilled artisan (page 12 lines 7-9). The composition is preferably administered orally (page 13
lines 11-14).
Larkins does not teach at least one excipient as required by the claims and a weight ratio
of the total active compounds to the at least one excipient.
Gullapalli teaches that polyethylene glycols (PEGs) are frequently employed as vehicles
in oral and parenteral dosage forms (abstract). Gullapalli teaches that PEGs are commercially
available in molecular weight grades from 200 to 10,000,000 g/mol. PEGs of molecular weight
200-600 are clear liquids and those of 1000 and above exist as semi-crystalline solids at room
temperature (see page 220, Introduction section).
The teachings of Larkins and Gullapalli are related to carriers for oral dosage forms and it
would have been obvious to have combined their teachings because they are in the same field of
endeavor. It would have been prima facie obvious to a person of ordinary skill in the art before
the effective filing date of the claimed invention to have formed a liquid formulation for oral
administration, the formulation comprising a conventional carrier, and a combination of paeonol
and apocynin in a weight ratio from 100:1 to 1:100 and preferably from 1:2 to 1:10, with a
reasonable expectation of success because Larkins teaches a formulation comprising a combination of paeonol and apocynin in a weight ratio from 100:1 to 1:100 and preferably from
1 :2 to 1: 10, and a pharmaceutically conventional carrier, wherein the formulation is a liquid
formulation and suitable for oral administration. Larkins does not teach suitable carriers for
making a liquid formulation. It would have been obvious to the skilled artisan to have looked to
Gullapalli because Gullapalli teaches that PEGs are ideal drug delivery vehicles because of their
ability to be miscible with aqueous fluids in all proportions and dissolve many poorly water-soluble compounds (page 220, section 2). Gullapalli teaches commercially available PEGs
include PEGs having molecular weight grades from 200 to 10,000,000 g/mol. PEGs of molecular
weight 200-600 are clear liquids and those of 1000 and above exist as semi-crystalline solids at
room temperature (see page 220, Introduction section). Thus, it would have been obvious to one
of ordinary skill in the art to have selected PEG 400 and utilized it to make the liquid formulation
in Larkins, with a reasonable expectation of success because PEG-400 was known as a clear
liquid suitable for solubilizing poorly water-soluble compounds and the purpose of Larkins was
to form a liquid formulation. The selection of a known material suitable for its intended purpose
supports obviousness.
The formulation in claim 1 is obvious over Larkins modified with Gullapalli because the
formulation is a liquid formulation comprising PEG-400 as the pharmaceutically conventional
carrier, and a combination of paeonol and apocynin in the range of ratios by weight from 2:1 to
10:1. The claimed range of weight ratios of paeonol to apocyanin (from 3:2 to 9:1) is obvious
because it overlaps with the preferred prior art range of from about 2:1 to 10:1. A range of from
3:2 to 9:1 is equivalent to a range of from 60:40 to 90:10. A range of from about 2:1 to about
10:1 is equivalent to a range of from about 67:33 to about 91:9. The claimed range of weight
ratios of paeonol to apocynin is obvious because it overlaps with the prior art range, and it has
been held that in the case where the claimed ranges overlap or lie inside ranges disclosed by the
prior art a prima facie case of obviousness exists.
Regarding weight ratio ranges of total active compounds to the at least one excipient in
claims 2, 8, 11, 28, and 29, Larkins does not teach the weight ratio of total active compounds to excipients in a liquid formulation. It would have been obvious to the skilled artisan to determine a concentration range of PEG-400 that is sufficient to form a liquid formulation of paeonol and
apocynin. One of ordinary skill in the art would have arrived at the concentration range through
routine experimentation. The claimed range of weight ratios is obvious because it is at least close
enough to the prior art range of weight ratios that a person skilled in the art would have expected
them to have the same properties. Both present claims and the prior art require a liquid
formulation comprising PEG-400 as the carrier, and a combination of apocynin and paeonol as
active agents. There would have been a reasonable expectation of success in arriving at the
claimed invention, including claimed weight ratios of active agents to excipient, through routine
experimentation. The specification was reviewed and there is no evidence that the claimed
combination of elements and their respective weight ratios are critical. Determining optimal
concentrations is routine experimentation and is readily practiced by one of ordinary skill.
Regarding claims 3-6, PEG-400 meets the claimed limitations.
Regarding claim 7, the preferred range of paeonol to apocynin is from about 2:1 to about
10: 1, which is equivalent to a range of from about 67:33 to about 91:9. The claimed range of
weight ratios of paeonol to apocynin is obvious because it overlaps with the prior art range.
Regarding claim 9, the prior art formulation contains the same elements as claimed
formulation and it would have been reasonable to the skilled artisan to conclude that the prior art
composition has the same properties as claimed composition when placed under identical conditions, including being stable at room temperature.
Regarding claims 23 and 24, prior art formulation contains the same components as claimed and it would have been suitable for treatment of inflammatory disease and neurodegenerative disease.
Regarding claim 25, it would have been obvious to have used the formulation to treat an inflammatory disease comprising administering the composition to a patient in need thereof, with a reasonable expectation of success because Larkins teaches that the compositions are suitable for the treatment of inflammatory diseases (page 9 lines 5-12), where the composition is administered to a subject (page 11 lines 5-15).
Claims 1-5, 7-9, 11, 23-25, 28, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Larkins (US 8,841,348 B2, Published September 23, 2014).
The claims encompass a liquid formulation as described by the claims.
The teachings of Larkins are related to compositions comprising apocynin and paeonol
(Abstract). A preferred composition comprises apocynin and paeonol in a ratio by weight
between about 1:2 to 1:10 (paragraph bridging columns 2-3). The compositions are suitable for
oral administration and are formed by methods known in the art. For example, compositions are
prepared using pharmaceutically acceptable carriers, and may be in the form of a liquid. The
compositions may be formed as a soft capsule, where the composition is dissolved in an
appropriate liquid such as polyethylene glycol (column 4 lines 23-44).
It would have been prima facie obvious to a person of ordinary skill in the art before the
effective filing date of the claimed invention to have formed a liquid formulation for oral
administration, the formulation comprising polyethylene glycol as a carrier, and a combination of
paeonol and apocynin in a weight ratio from 1:2 to 1:10, with a reasonable expectation of
success because Larkins teaches a formulation comprising a combination of paeonol and
apocynin in a preferred weight ratio from 1:2 to 1:10, and a carrier selected from polyethylene
glycol, wherein the formulation is a liquid formulation and suitable for oral administration.
The formulation in claim 1 is obvious over Larkins because the formulation is a liquid
formulation comprising polyethylene glycol carrier, and a combination of paeonol and apocynin
in the range of ratios by weight from 2:1 to 10:1. The claimed range of weight ratios of paeonol
to apocyanin (from 3:2 to 9:1) is obvious because it overlaps with the preferred prior art range of
from about 2:1 to 10:1. A range of from 3:2 to 9:1 is equivalent to a range of from 60:40 to
90: 10. A range of from about 2:1 to about 10:1 is equivalent to a range of from about 67:33 to
about 91:9. The claimed range of weight ratios of paeonol to apocynin is obvious because it
overlaps with the prior art range, and it has been held that in the case where the claimed ranges
overlap or lie inside ranges disclosed by the prior art a prima facie case of obviousness exists.
Regarding weight ratio ranges of total active compounds to the at least one excipient in
claims 2, 8, 11, 28, and 29, Larkins does not teach the weight ratio of total active compounds to excipients in a liquid formulation. It would have been obvious to the skilled artisan to determine a concentration range of polyethylene glycol that is sufficient to form a liquid formulation of
paeonol and apocynin dissolved in PEG. One of ordinary skill in the art would have arrived at the concentration range through routine experimentation. The claimed range of weight ratios is obvious because it is at least close enough to the prior art range of weight ratios that a person skilled in the art would have expected them to have the same properties. Both present claims and the prior art require a liquid formulation comprising polyethylene glycol as the carrier, and a combination of apocynin and paeonol as active agents. There would have been a reasonable expectation of success in arriving at the claimed invention, including claimed weight ratios of active agents to excipient, through routine experimentation. The specification was reviewed and there is no evidence that the claimed combination of elements and their respective weight ratios are critical. Determining optimal concentrations is routine experimentation and is readily practiced by one of ordinary skill.
Regarding claims 3-5, polyethylene glycol meets the claimed limitations.
Regarding claim 7, the preferred range of paeonol to apocynin is from about 2:1 to about
10:1, which is equivalent to a range of from about 67:33 to about 91:9. The claimed range of
weight ratios of paeonol to apocynin is obvious because it overlaps with the prior art range.
Regarding claim 9, the prior art formulation contains the same components as claimed
formulation and it would have been reasonable to the skilled artisan to conclude that the prior art
composition has the same properties as claimed composition when placed under identical conditions, including being stable at room temperature.
Regarding claims 23 and 24, prior art formulation contains the same components as claimed and it would have been suitable for treatment of inflammatory disease and neurodegenerative disease.
Regarding claim 25, it would have been obvious to have used the formulation to treat an inflammatory disease comprising administering the composition to a patient in need thereof, with a reasonable expectation of success because Larkins teaches that the compositions are suitable for the treatment of inflammatory diseases (column 5 lines 1-3), where the composition is administered to a subject (column 5 lines 25-35).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Larkins as applied to
claims 1-5, 7-9, 11, 23-25, 28, and 29 above, and further in view of Gullapalli.
The claim is drawn to a composition of claim 1 wherein the at least one excipient is
polyethylene glycol 400.
The teachings of Larkins are relied upon as summarized above. Larkins does not
specifically teach PEG-400.
Gullapalli teaches that polyethylene glycols (PEGs) are frequently employed as vehicles
in oral and parenteral dosage forms (abstract). Gullapalli teaches that PEGs are commercially
available in molecular weight grades from 200 to 10,000,000 g/mol. PEGs of molecular weight
200-600 are clear liquids and those of 1000 and above exist as semi-crystalline solids at room
temperature (see page 220, Introduction section).
The teachings of Larkins and Gullapalli are related to carriers for oral dosage forms and it
would have been obvious to have combined their teachings because they are in the same field of
endeavor. Larkins does not teach specific PEGs suitable for making liquid formulations. It would
have been prima facie obvious to a person skilled in the art to have selected PEG-400 because it
was known from Gullapalli that PEG 200-600 is a clear liquid that is suitable for making liquid
formulations of compositions intended for oral administration. Combining prior art elements
according to known methods to obtain predictable results supports obviousness and the selection
of a known material suitable for its intended purpose supports obviousness.
Double Patenting Rejections
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.
Claims 1, 7, 9, 10, 12, 13, 19-24, 26, and 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,701,325 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because patented claims are dawn to liquid formulations comprising a eutectic mixture of paeonol or isomer thereof and apocynin or isomer thereof, and an excipient, which renders the compositions in claims 1, 7, 10, 12, 13, 19, 20, 21, 26, and 27 obvious. Regarding the ratio range in claim 7, the ratio is a eutectic ratio of the two compounds as evidenced by instant claim 21. Claims 9 and 22 are obvious because patented composition contains the same components as instantly claimed composition and it would have been obvious to expect the patented composition to have the same properties as claimed composition when placed under identical conditions. Claims 23 and 24 are obvious because patented composition would have been suitable for treating inflammatory disease and neurodegenerative disease because patented composition has the same components as instantly claimed composition.
Claims 2-6, 8, 11, 14-18, 25, and 28-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,701,325 B2 as applied to claims 1, 7, 9, 10, 12, 13, 19, 19-24, 26, and 27 above, and further in view of Larkins et al. (GB2424833 A, published 11/10/2006 – of record in IDS dated 06/01/2023) in view of Gullapalli et al. (International Journal of Pharmaceutics 496 (2015) 219-239 – of record in IDS dated 06/01/2023).
The teachings of patented claims, Larkins, and Gullapelli are relied upon as summarized above.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have formed the liquid formulation in patented claims using PEG-400 because Larkins teaches a liquid formulation comprising a mixture of apocynin and paeonol and an excipient, useful for treating inflammatory conditions by administering orally to a subject in need; and it was known from Gullapelli that PEG-400 is a commercially available liquid excipient suitable for making liquid oral formulations. Limitations in claims 2-6 and 14-17 are met with PEG-400.
Regarding weight ratio ranges of total active compounds to the at least one excipient in
claims 2, 8, 11, 18, 28, 29, and 30, patented claims and Larkins do not teach the weight ratio of total active compounds to excipients in a liquid formulation. It would have been obvious to the skilled artisan to determine a concentration range of PEG-400 that is sufficient to form a liquid formulation of paeonol and apocynin dissolved in PEG-400. One of ordinary skill in the art would have arrived at the claimed range of ratios through routine experimentation. The claimed range of weight ratios is obvious because it is at least close enough to the prior art range of weight ratios that a person skilled in the art would have expected them to have the same properties. Both present claims and patented claims modified by Larkins and Gullapelli require a liquid formulation comprising polyethylene glycol as the carrier, and a combination of apocynin and paeonol as active agents. There would have been a reasonable expectation of success in arriving at the claimed invention, including claimed weight ratios of active agents to excipient, through routine experimentation. The specification was reviewed and there is no evidence that the claimed combination of elements and their respective weight ratios are critical. Determining optimal concentrations is routine experimentation and is readily practiced by one of ordinary skill.
Regarding claim 25, it would have been obvious to have used the patented formulation as modified by Larkins and Gullapelli to treat an inflammatory disease comprising administering the composition to a patient in need thereof, with a reasonable expectation of success because Larkins teaches that the compositions are suitable for the treatment of inflammatory diseases, where the composition is administered to a subject.
Conclusion
No claims are allowed.
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/ALMA PIPIC/Primary Examiner, Art Unit 1617
Prosecution Insights