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 .
Election/Restrictions
Applicant’s election without traverse of Group II, (drawn to a method of treating inflammation in a subject), and the species of reducing inflammasome-mediated inflammation, in the reply filed on 10/29/2024 is acknowledged.
Claim 1-16 and 18-22 are pending of which (claims 1-11 (Group I)) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 15-19 read upon the elected species, however, the additional claims rejected herein are rejected to demonstrate the non-allowability of the generic claims. The restriction requirement is still deemed proper and is made Final.
Pending claims 12-16, 18-22 have been examined on the merits.
Response to Pre-Appeal Argument
Applicant’s argument has been found persuasive; therefore the 103 rejection is withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 12-16, 18-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 12, 15, and 20, recite an effective amount of the composition to re-differentiate chondrocytes, inhibit GasDermin D and reduce inflammasome-mediated inflammation in the subcutaneous tissue. However, specification (page 6, [0020]-[0021]); page 27, [0125]), provides only in vitro data, including cell cultured chondrocytes marker expression and inflammasome assays in differentiated THP-1 cells. The disclosure does not provide in vivo data demonstrating that topical administration delivers the composition to the subcutaneous tissue or cartilage in an amount sufficient to re-differentiate chondrocyte. Since a person of ordinary skill in the art (POSITA) would recognize that topical anti-inflammatory efficacy and effect in underlying tissue are typically evaluated in vivo, thus a POSITA would expect reduction in skin thickness or inflammatory cells infiltration to be measured. The specification provides no such data or guidance on how to evaluate the anti-inflammatory properties of the instant claim. Therefore, without in vivo evidence demonstrating measurable anti-inflammatory effects in skin or underlying tissue, it is not reasonably clear that re-differentiation occurred in subcutaneous tissue. Therefore, it is clearly evident that the specification fails to demonstrate possession of the claimed method at the time of filing of the instant application.
Regarding GasDermin D and inflammasome, the specification provides no data or discussion demonstrating that the claimed composition inhibits GasDermin D; in fact, the specification is silent regarding any mechanism or measurement supporting such effect. Furthermore, the specification provides only in vitro data showing reduction of IL-1B and cell viability, with the intent to demonstrate a link between these measurements and ‘inflammasome-mediated inflammation’ which a POSITA would view as inferential or extrapolation, rather supported by direct measurement of inflammasome activity. Moreover, regarding inflammasome, the claim refers to “a level before administering the composition” without defining a baseline or control level. Without such information, it would be nearly impossible to determine what the expected level should be, or whether any change following administration represents a meaningful reduction.
Thus, the disclosure does not establish Applicant was in possession of the claimed functional effects of Gasdermin D inhibition or direct inflammasome modulation at the time of filing. Therefore, it is clearly evident that the specification fails to demonstrate possession of the claimed method at the time of filing the instant application.
Note: regarding the importance of in vivo testing, Wang (page 103) discloses the
importance of in vivo experiment for evaluating topical application and obtaining meaningful data on drug absorption after a topical application.
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Here, Wang clearly indicates that in vitro data alone is insufficient to demonstrate therapeutic effectiveness of a topical application in the skin; or even that the composition reaches the intended tissue at a sufficient concentration.
Therefore, claims 16, and 18-19 recite composition “partitions” fatty acids and tryptophan through the skin into the subcutaneous environment is purely speculative. The specification clearly fails to provide quantitative data, or in vivo studies demonstrating that the composition actually reaches the subcutaneous tissue in an effective amount. As recognized by Wang, in vitro studies alone, not even artificial membrane, do not reliably predict in vivo skin penetration or therapeutic effect, that the composition reaches the intended tissue at sufficient concentration. Therefore, because the specification provides no such in vivo experiment or reliable models, the claimed of fatty acids and tryptophan partition through the skin is indeed speculative, which then demonstrates that Applicant was not in possession of the claimed invention at the time of filing the instant application.
Claims 13-14 and 21-22, recite a method of treating osteoarthritis and many of inflammatory disorders by administering the claimed composition to a subject presenting the disease or symptoms thereof. While the specification (page 30-31) reports examples stating that the composition was administered to human subjects reporting including but not limited to osteoarthritis, psoriasis, and back pain. The specification, however, provides no experimental data, guidance on frequency of application, pain level reduction or validated models demonstrating that administration would result in the claimed therapeutic effects. The specification does not provide data showing that the claimed composition is effective against any of the claimed inflammatory disorders, nor does it demonstrate reduction in inflammation, tissue pathology, quantitative endpoint in treated subjects. Therefore, the claimed conclusions in the specification would be inferred by a POSITA as speculative, because there is no reliable evidence that Applicant was in possession of the claimed method of treatment inflammatory disorders at the time of filing of the instant claim.
The specification’s failures to disclose a proper in vivo data regarding a method to treat inflammation in a subject, clearly supports the conclusion that the specification lacks adequate written description of the claimed subject matter indicating that Applicant was not in possession of the claimed method at the time of filling of the instant application in view of the disclosure of the application as filed.
Conclusion
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/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622