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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/30/2026 has been entered.
Status of the Application
Claims 1 and 16-23 are pending, of which Claims 19-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1, 16-18, 22-23 are under current examination.
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 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 of this title, 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 16-18, 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Vedros (US 5198217) and Klein (US 20160220601 A1) in combination.
Determining the scope and contents of the prior art
Vedros discloses a topical spray composition for treating inflammation comprising tannic acid 0.8-1.5% (encompassed by excipient of instant claims 16), licorice extract 0.025% to 0.75% (elected species) and carrageenan 0.1-1.5% W/V (sulfated polysaccharide, obtained from red algae)
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(0.025:0.1=0.25=1:4, within limits of ratio of anti-inflammatory agent: sulfated polysaccharide of the instant claims) with further example having tannic acid 1.0%, glycerin 20%, pectin 1%, sodium benzoate 0.25%, distilled water (all are encompassed by excipients of instant claims 16), licorice extract 0.025% (elected species) and carrageenan 0.1% (0.025:0.1=0.25=1:4, within limits of ratio of anti-inflammatory agent: sulfated polysaccharide of the instant claims) (entire patent).
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Since licorice extract of the cited prior art is same and obtained from same source licorice as in the instant claims, the extract of the cited prior art is expected to comprise same components glycyrrhetinic acid and glycyrrhizin.
Since, the instant claim 18 is drawn to every release profile and the composition of the cited prior art is expected to have at least one release profile, such as immediate etc., the cited prior art meets limitation of the instant claims.
Ascertaining the differences between the prior art and the claims at issue
Vedros discloses a topical spray composition for treating inflammation comprising tannic acid 0.8-1.5% (encompassed by excipient of instant claims 16), licorice extract 0.025% to 0.75% (elected species) and carrageenan 0.1-1.5% W/V (sulfated polysaccharide, obtained from red algae), but fails to teach sulfated polysaccharide from red algae Porphyridium species.
Resolving the level of ordinary skill in the pertinent art
With regards to the difference of sulfated polysaccharide from red algae Porphyridium species, Vedros discloses a topical spray composition for treating inflammation comprising tannic acid 0.8-1.5% (encompassed by excipient of instant claims 16), licorice extract 0.025% to 0.75% (elected species) and carrageenan 0.1-1.5% W/V, a sulfated polysaccharide, obtained from red algae.
Thus, with the guidance provided by Vedros, it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of success that sulfated polysaccharides obtained from any red algae, such as carrageenan obtained from red algae Chondrus crispus as taught by Vedros may be useful in making a composition useful for treating inflammation. Additionally, it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of success that sulfated polysaccharide obtained from Chondrus crispus may be substituted with sulfated polysaccharide obtained from other red algae species.
Further, Case law has established that it is prima facie obvious to substitute one known element for another to obtain predictable results. KSR Int'I Co. v. Teleflex, Inc., 550 U.S. 398 (2007). Thus, the cited prior art meets all limitations of the instant claims.
This deficiency is further cured by Klein.
In the same field of endeavor of treating inflammation, Klein teaches a composition in the form of gel, cream, pill, tablet etc. comprising porphyridium sulfated polysaccharide 0.1%w/w (same sulfated polysaccharide as in the instant claims) or sulfated polysaccharides obtained from other red algae, such as Chondrus crispus:
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, anti-inflammatory agent, such as glycyrrhiza (same as elected species licorice extract), green tea extract 0.1%W/W (1:1, within limits of ratio of anti-inflammatory agent: sulfated polysaccharide of the instant claims), and excipients, such as buffer, anti-microbial agent etc. (all are encompassed by excipients of instant claims) with example:
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(entire application, especially claims, paragraph 0069, page 5-6, 12-14, Table 3).
Thus, with the guidance provided by Vedros and Klein, it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of success that sulfated polysaccharides obtained from any red algae, such as carrageenan obtained from red algae Chondrus crispus as taught by Vedros or porphyridium sulfated polysaccharide or Chondrus crispus sulfated polysaccharide (carrageenan) as taught by Klein may be useful in making a composition useful for treating inflammation. Further, Klein teaches that sulfated polysaccharide obtained from Chondrus crispus or porphyridium species may be useful in making such composition. Based on combined teachings of the cited prior art, it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of success that sulfated polysaccharide obtained from Chondrus crispus may be substituted with sulfated polysaccharide obtained from porphyridium species.
Further, Case law has established that it is prima facie obvious to substitute one known element for another to obtain predictable results. KSR Int'I Co. v. Teleflex, Inc., 550 U.S. 398 (2007). Thus, the cited prior art meets all limitations of the instant claims.
Since the anti-inflammatory agent and the sulfated polysaccharide are present in same relative amounts as in the instant claims the interaction between them is expected to be synergistic interaction. Further, since the cited prior art teaches same composition comprising same components as in the instant claims, release profile of the composition of the cited prior art is expected to be same as in the instant claims.
Based on the above established facts, it appears that the combination of teachings of above cited prior art read applicants’ composition.
Therefore, all the claimed elements were known in the prior art and one skilled person in the art could have modified the elements as claimed by known methods with no change in their respective functions, and the modification would have yielded predictable to one of ordinary skill in the art at the time of the invention.
Considering objective evidence present in the application indicating obviousness or nonobviousness
To establish a prima facie case of obviousness, three basic criteria must be met: (1) the prior art reference must teach or suggest all the claim limitations; (2) there must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings; and (3) there must be a reasonable expectation of success; and (MPEP § 2143).
In this case, Vedros discloses a topical spray composition for treating inflammation comprising tannic acid 0.8-1.5% (encompassed by excipient of instant claims 16), licorice extract 0.025% to 0.75% (elected species) and carrageenan 0.1-1.5% W/V (sulfated polysaccharide, obtained from red algae) and Klein teaches a composition in the form of gel, cream, pill, tablet etc. comprising porphyridium sulfated polysaccharide 0.1%w/w (same sulfated polysaccharide as in the instant claims) or sulfated polysaccharides obtained from other red algae, such as Chondrus crispus. So, the combination of prior art read applicants claims.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” (Id. At 1395). See MPEP 2143 - Examples of Basic Requirements of a Prima Facie Case of Obviousness [R-9].
In this case at least prong (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success would apply.
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”KSR, 550 U.S. at ___, 82 USPQ2d at 1397. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art. Further, there is a reasonable expectation of success that sulfated polysaccharide obtained from Chondrus crispus may be substituted with sulfated polysaccharide obtained from porphyridium species and can be made by combination of the above cited prior art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited references and to make the instantly claimed composition with a reasonable expectation of success.
Response to Arguments
Applicants’ amendments and remarks, filed on 07/30/2026, have been fully considered but not found persuasive.
Applicant argued that there is no reason to combine Vedros and Klein as there is no reason proposed in the office action.
This is not found persuasive and the instant claims stand rejected over combination of Vedros and Klein. This is because contrary to applicants’ argument, the office did provide reasoning for the combination. Importantly, Vedros and Klein teaching is in the same field of endeavor of providing anti-inflammatory compositions using SPS from red algae and anti-inflammatory agent. As explained in detail in the office action, Vedros discloses a topical spray composition for treating inflammation comprising tannic acid 0.8-1.5% (encompassed by excipient of instant claims 16), licorice extract 0.025% to 0.75% (elected species) and carrageenan 0.1-1.5% W/V, a sulfated polysaccharide, obtained from red algae.
Thus, with the guidance provided by Vedros, it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of success that sulfated polysaccharides obtained from any red algae, such as carrageenan obtained from red algae Chondrus crispus as taught by Vedros may be useful in making a composition useful for treating inflammation. Additionally, it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of success that sulfated polysaccharide obtained from Chondrus crispus may be substituted with sulfated polysaccharide obtained from other red algae species.
Further, Case law has established that it is prima facie obvious to substitute one known element for another to obtain predictable results. KSR Int'I Co. v. Teleflex, Inc., 550 U.S. 398 (2007). Thus, the cited prior art meets all limitations of the instant claims.
This deficiency is further cured by Klein.
In the same field of endeavor of treating inflammation, Klein teaches a composition in the form of gel, cream, pill, tablet etc. comprising porphyridium sulfated polysaccharide 0.1%w/w (same sulfated polysaccharide as in the instant claims) or sulfated polysaccharides obtained from other red algae, such as Chondrus crispus:
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, anti-inflammatory agent, such as glycyrrhiza (same as elected species licorice extract), green tea extract 0.1%W/W (1:1, within limits of ratio of anti-inflammatory agent: sulfated polysaccharide of the instant claims), and excipients, such as buffer, anti-microbial agent etc. (all are encompassed by excipients of instant claims) with example:
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(entire application, especially claims, paragraph 0069, page 5-6, 12-14, Table 3).
Thus, with the guidance provided by Vedros and Klein, it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of success that sulfated polysaccharides obtained from any red algae, such as carrageenan obtained from red algae Chondrus crispus as taught by Vedros or porphyridium sulfated polysaccharide or Chondrus crispus sulfated polysaccharide (carrageenan) as taught by Klein may be useful in making a composition useful for treating inflammation. Further, Klein teaches that sulfated polysaccharide obtained from Chondrus crispus or porphyridium species may be useful in making such composition. Based on combined teachings of the cited prior art, it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of success that sulfated polysaccharide obtained from Chondrus crispus may be substituted with sulfated polysaccharide obtained from porphyridium species.
Further, Case law has established that it is prima facie obvious to substitute one known element for another to obtain predictable results. KSR Int'I Co. v. Teleflex, Inc., 550 U.S. 398 (2007). Thus, the cited prior art meets all limitations of the instant claims.
Since the anti-inflammatory agent and the sulfated polysaccharide are present in same relative amounts as in the instant claims the interaction between them is expected to be synergistic interaction. Further, since the cited prior art teaches same composition comprising same components as in the instant claims, release profile of the composition of the cited prior art is expected to be same as in the instant claims.
Applicant argued that SPS derived from Porphyridium species in Example 6 of Klein relates to water retention ability of formulation and the example provides no information concerning any possible anti-inflammatory activity of the combination Porphyridium SPS and licorice extract. Applicant argued that the anti-inflammatory agent in Example 6 is a green tea extract and this information cannot be extrapolated to anti-inflammatory compound licorice or licorice extract. Applicant argued that from Klein’s teaching, it may be concluded that an attempt could be made to combine Porphyridium SPS with an anti-inflammatory agent but not with anti-inflammatory agent licorice or licorice extract.
In response to applicants’ arguments against the references individually, Klein, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
As agreed by the applicant from Klein’s teaching, an ant-inflammatory composition may be made with combination of Porphyridium SPS with an anti-inflammatory agent. If Klein had taught combination of Porphyridium SPS with anti-inflammatory agent licorice or licorice extract, the rejection would have been anticipation and not obvious. In the instant case, Vedros discloses a topical spray composition for treating inflammation comprising tannic acid 0.8-1.5% (encompassed by excipient of instant claims 16), licorice extract 0.025% to 0.75% (elected species) and carrageenan 0.1-1.5% W/V, a sulfated polysaccharide, obtained from red algae. In the same field of endeavor of treating inflammation, Klein teaches a composition in the form of gel, cream, pill, tablet etc. comprising porphyridium sulfated polysaccharide 0.1%w/w (same sulfated polysaccharide as in the instant claims) or sulfated polysaccharides obtained from other red algae, such as Chondrus crispus:
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, anti-inflammatory agent, such as glycyrrhiza (same as elected species licorice extract), green tea extract 0.1%W/W (1:1, within limits of ratio of anti-inflammatory agent: sulfated polysaccharide of the instant claims), and excipients, such as buffer, anti-microbial agent etc. (all are encompassed by excipients of instant claims) with example.
Thus, with the guidance provided by Vedros and Klein, it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of success that sulfated polysaccharides obtained from any red algae, such as carrageenan obtained from red algae Chondrus crispus as taught by Vedros or porphyridium sulfated polysaccharide or Chondrus crispus sulfated polysaccharide (carrageenan) as taught by Klein may be useful in making a composition useful for treating inflammation. Further, Klein teaches that sulfated polysaccharide obtained from Chondrus crispus or porphyridium species may be useful in making such composition. Based on combined teachings of the cited prior art, it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of success that sulfated polysaccharide obtained from Chondrus crispus may be substituted with sulfated polysaccharide obtained from porphyridium species.
Further, Case law has established that it is prima facie obvious to substitute one known element for another to obtain predictable results. KSR Int'I Co. v. Teleflex, Inc., 550 U.S. 398 (2007). Thus, the cited prior art meets all limitations of the instant claims.
Applicant argued over a limitation that is not recited in the instant claims, specifically, of role that SPS derived from Porphyridium species in Example 6 of Klein relates to water retention ability of formulation. There is no role recited in the instant claims and the instant claims includes every role of SPS.
Conclusion
No claim is allowed.
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/PANCHAM BAKSHI/Primary Examiner, Art Unit 1623
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