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
A new claim set was filed on 6/22/26 with the following:
Amended claims
Newly canceled claims
Newly added claims
Previously canceled claims
1-5, 13-21, 30-62, 68
Instantly withdrawn claims
63-66
Claims under instant examination
6-12, 22-29, 67
Election/Restrictions
Applicants’ election of Group I (claims 6-12, 22-29, 67) drawn to a coated silk fibroin article, is acknowledged. The election was made without traverse.
As the requirement for restriction is deemed proper, it is maintained and hereby made FINAL.
Claims 63-66 are hereby withdrawn from further consideration by the Examiner, pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. The instant claims have been examined commensurate with the scope of the elected invention. Applicants timely responded to the restriction requirement in the reply filed 6/22/26.
Accordingly, claims 6-12, 22-29 and 67 are under current examination.
Claim Rejections - 35 USC § 112(a), Written Description
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.
Claims 8-12, 22-29 and 67 are rejected under 35 U.S.C. §112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter that was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. Applicants are directed to the Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112 ¶1 "Written Description" Requirement, Rev. 1, 2008; at http://www.uspto.gov/web/menu/written.pdf.
The claims broadly embrace a coated article having controllable active agent release rates, the article comprises a solid dosage form core comprising an active agent and a polycaprolactone coating encapsulating the solid dosage form core, necessitating structure/function relationships.
The specification discloses only silk fibroin as the solid dosage core with the scope of claim 67 having the required activities (a solid dosage core that provides controllable active agent release rates of the active agent in the core). However, in the absence of the compounds/materials being used, the artisan, would not have accepted that applicant was in possession of the claimed coated article comprising any material in the core. The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See, e.g., In re Wilder, 22 USPQ 369, 372-3 (Fed. Cir. 1984). (Holding that a claim was not adequately described because the specification did 'little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.') Mere indistinct terms (such as known classes of compounds which are now claimed based on a limited functional capability, such as “solid dosage form core” however, may not suffice to meet the written description requirement. This is particularly true when known compound classes, which otherwise meet the written description requirement, are limited to a smaller subgroup claimed in purely functional terms, such as the case in the instant claims. See Univ. of Rochester v. G.D. Searle, 69USPQ2d 1886 (CAFC 2004) at 1892, stating: The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. A description of an anti-inflammatory steroid, i.e., a steroid (a generic structural term) described even in terms of its functioning of lessening inflammation of tissues fails to distinguish any steroid from others having the same activity or function. A description of what a material does, rather than of what it is, usually does not suffice. The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described. (Emphasis added). Conversely, a description of a chemical genus will usually comprise a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. See Univ. of Calf. V. Eli Lilly, 43 USPQ 2d 1398, 1406 (Fed. Cir. 1997). This is analogous to enablement of a genus under Section 112, ¶ 1, by showing the enablement of a representative number of species within the genus. A chemical genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. (Emphasis added). If the genus has substantial variance, the disclosure must describe a sufficient number of species to reflect the variation within that genus. See MPEP §2163. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient. MPEP §2163. Here, the specification does not provide a reasonably representative disclosure of useful compounds which are “ophthalmic agents”.
Claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefinite concerns outlined above.
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.
Claim 22 is rejected under 35 U.S.C. 112(b) 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.
The term "substantially" in claim 22 is a relative term, which renders the claim indefinite. The term "substantially" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention; specifically, how uniform does the thickness have to be, to read on “substantially uniform thickness”.
Claim Rejections - 35 USC § 112(d)
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.
Claims 7-12 and 22-29 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to contain a reference to a claim previously set forth. Claims 7-12, 22-25 and 28-29 are dependent from claim 67 (i.e., claim 67 is not a claim previously set forth). It is noted that claims 26-27 depend from claim 25 and therefore are included in the rejection. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Citation of Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Deng et al. (CN109498837; published: 3/22/19) is directed to a method of combining coaxial electrostatic spinning and layer-by-layer self-assembly for synergistic gradient release of growth factors [Title]. Deng teaches wherein the care layer can be silk fibroin and the shell layer wrapping the core layer is made of polycaprolactone. Deng teaches a long-term release of the core layer and an instantaneous release of the shell, but does not teach wherein three claimed release rates are affected by temperature as instantly claimed.
Allowable Subject Matter
Claim 6 is free of the prior art.
See Interview Summary for the Examiner’s suggestion to reach allowability.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GENEVIEVE S ALLEY whose telephone number is (571)270-1111. The examiner can normally be reached Monday-Friday 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached at 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GENEVIEVE S ALLEY/ Primary Examiner, Art Unit 1617
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