DETAILED ACTION
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 . 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.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-9, 11, 18, 20, 24, 26, 33-34, 36, and 39) and the species of miR-29b (for the species of agent for treating a condition or disorder associated with collagen deficiency, for preventing or treating a skin disease or disorder, or for improving a skin condition) and liposome (for the species of the form of the composition) in the reply filed on 06 January 2026 is acknowledged. Claims 43-44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 2, 4-9, and 36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of agent for treating a condition or disorder associated with collagen deficiency, for preventing or treating a skin disease or disorder, or for improving a skin condition, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 and 39 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Independent claim 1 (and dependent claim 39) are directed to a composition comprising an agent for treating a condition or disorder associated with collagen deficiency, for preventing or treating a skin disease or disorder, or for improving a skin condition. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only components listed are the naturally occurring ingredients.
The analysis set forth for evaluating subject matter eligibility under section 101 is discussed in MPEP 2106. Step 1 is to determine if the claim is to a process, machine, manufacture, or a composition of matter. For the instantly recited invention, this is true. The claims are directed to a composition of matter. Thus, the analysis continues to step 2A.
Step 2A consists of two prongs. The first prong of step 2A is if the claim recites an abstract idea, a law of nature, or a natural phenomenon. The claims are directed to a composition comprising, among options, miR-29b (the elected species of agent for treating a condition or disorder associated with collagen deficiency, for preventing or treating a skin disease or disorder, or for improving a skin condition). And this is naturally occurring, as demonstrated by Brown et al. (US Patent Application Publication 2011/0313025), which states that miR-29b is human (paragraph [60]). Thus, the claims are drawn to products of nature, and the analysis continues to the second prong of step 2A.
The second prong of step 2A is does the claim recite additional elements that integrate the judicial exception into a practical application. The claims are directed to a composition or kit with this agent, and there is no elements recited as limitations which integrate the agent further into a practical application. Thus, as there is nothing else in the claim other than the judicial exception, the analysis continues to step 2B.
Step 2B is does the claim recite additional elements that amount to significantly more than the judicial exception. And the instant claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only component listed is the naturally occurring ingredient. There is no limitation to the claimed invention requiring anything which is not drawn to a judicial exception. Thus, the claims are considered to not be drawn to eligible subject matter under 35 USC 101.
Claim Rejections - 35 USC § 112 – 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 1, 3, 11, 18, 20, 24, 26, 33-34, and 39 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims 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 at the time the application was filed, had possession of the claimed invention.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004). See also Ariad Pharmaceuticals Inc. v. Eli Lilly & Co. 94 USPQ2d 1161, 1176-77 (Fed. Cir. 2010). When there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004). See also MPEP 2163.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004). See also MPEP 2163 for a detailed discussion of guidelines concerning analysis of written description issues.
Here, the state of the art is poorly developed with regard to the claimed subject matter, as confirmed by the specification, which states that within the narrower scope of treating undesired skin ageing appearance physiology, or structural changes, that topically applied siRNA does not exert a strong therapeutic effect.
Conversely, the specification discloses/reduces to practice only a limited number of species of peptides and ways to deliver peptides (see examples 1-7) using liposomes for a select number of sequences. Further, the conditions treated are those relating to the appearance of skin and aging, whereas the claims are broader in scope and not so limited. These are not viewed as being reasonably representative of the genus in its claimed scope because no readily apparent combination of identifying characteristics is provided, other than the disclosure of those specific species as examples of the claimed genus. Accordingly, the specification does not appear to adequately describe the claimed genus.
Claim Rejections - 35 USC § 112 – Scope of Enablement
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 1, 3, 11, 18, 20, 24, 26, 33-34, and 39 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for treating, does not reasonably provide enablement for the full scope of the disease and conditions claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).1
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The nature of the invention, state and predictability of the art, and relative skill level: The invention relates to methofds of treating conditions or disorder associated with collagen deficiency, prevention or treating skin diseases or disorders, and improving skin conditions. The relative skill of those in the art is high, that of an M.D. or Ph.D. That factor is outweighed, however, by the unpredictable nature of the art. The Examiner cannot ascertain the predictability of the art, as there appears to be no guidance in the art as to how to make and use the full scope of the invention.
The breadth of the claims: The claims are broadly drawn to the treatment of a wide scope of conditions and diseases, and claim 1 is not limited in scope to the agent employed
The amount of direction or guidance provided and the presence or absence of working examples: The specification provides no direction or guidance for practicing the claimed invention in its “full scope”. No reasonably specific guidance is provided concerning useful therapeutic protocols for all of the conditions, diseases, and the like are provided, other than those like acne, wrinkles, and pigmentation (see page 33 of the specification). The latter is corroborated by the working examples.
The quantity of experimentation necessary: Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed diseases and conditions could all be predictably be treated as inferred by the claim and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the claimed invention in its “full scope” a person of ordinary skill in the art would have to engage in undue experimentation, with no reasonable expectation of success.
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.
(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 and 39 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Brown et al. (US Patent Application Publication 2011/0313025).
Brown et al. discloses compositions for introducing miRNA activity into cells using nucleic acid molecules (abstract). These can be used to treat diseases and conditions (paragraph [60]), and specific embodiments use human miR-29b (id.), which is the instantly elected species of agent for treating a condition or disorder associated with collagen deficiency, for preventing or treating a skin disease or disorder, or for improving a skin condition.
Claim 1 further recites that the composition comprises and agent for the species of agent for treating a condition or disorder associated with collagen deficiency, for preventing or treating a skin disease or disorder, or for improving a skin condition. Brown et al. does not state that the miR-29b is for this purpose. However, Brown et al. teaches the elected species of agent, and thus this agent has the property of being such an agent.
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.
Claims 3, 11, 20, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al. (US Patent Application Publication 2011/0313025).
Brown et al. discloses compositions for introducing miRNA activity into cells using nucleic acid molecules (abstract). These can be used to treat diseases and conditions (paragraph [60]), and specific embodiments use human miR-29b (id.), which is the instantly elected species of agent for treating a condition or disorder associated with collagen deficiency, for preventing or treating a skin disease or disorder, or for improving a skin condition.
Claim 1 further recites that the composition comprises and agent for the species of agent for treating a condition or disorder associated with collagen deficiency, for preventing or treating a skin disease or disorder, or for improving a skin condition. Brown et al. does not state that the miR-29b is for this purpose. However, Brown et al. teaches the elected species of agent, and thus this agent has the property of being such an agent.
Brown et al. further suggests using liposomes to deliver the nucleic acids (paragraph [302]). This carrier or lipid will increase cellular uptake, and can include cationic lipids such as DOTAP (paragraph [303]).
Instant claim 26 recites the further inclusion of a skin-penetration enhancer, which the instant specification states can be ethanol (page 3, lines 9-10). Brown et al. suggests the composition can be in liquid form with a carrier, such as ethanol (paragraph [314]).
Thus, Brown et al. teaches all of the limitations recited by the instant claims (miR-29b as the nucleic acid molecule and liposome as the form). Together these would provide a composition as instantly claimed. However, Brown et al. is not anticipatory insofar as the combination must be selected from various lists/locations in the reference. It would have been prima facie obvious, however, to make the combination since each component is taught as being useful in making the compositions of the prior art. Since this modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions a prima facie case of obviousness exists. See MPEP 2141.
Claims 18, 24, and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al. (US Patent Application Publication 2011/0313025) as applied to claim 3 above, and further in view of Harvie et al. (US Patent Application Publication 2003/0203865).
Brown et al. discloses compositions for introducing miRNA activity into cells using nucleic acid molecules (abstract). These can be used to treat diseases and conditions (paragraph [60]), and specific embodiments use human miR-29b (id.), which is the instantly elected species of agent for treating a condition or disorder associated with collagen deficiency, for preventing or treating a skin disease or disorder, or for improving a skin condition.
Brown et al. further suggests using liposomes to deliver the nucleic acids (paragraph [302]). This carrier or lipid will increase cellular uptake, and can include cationic lipids such as DOTAP (paragraph [303]). Brown et al. also states that the disclosure of other references are incorporated by reference with respect to formulations useful for administering nucleic acids, and these include Harvie et al. (paragraph [303]).
Harvie et al. discloses lipid-comprising drug delivery complexes useful for gene therapy (abstract). These include a lipid species, a polycation, and a targeting factor (id.).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have used the delivery formulations taught by Harvie et al. for the nucleic acids taught by Brown et al. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07.
Instant claim 18 recites the further inclusion of a cell-penetrating peptide. Harvie et al. discloses the known use of cell membrane-translocation peptides to assist delivery of nucleic acids into cells (paragraph [15]).
Instant claim 24 recites the further inclusion of an edge activator (of which the instant specification states includes Tween (page 38, lines 3-5). Harvie et al. suggests the inclusion of neutral lipids such as lipophilic surfactants such as Tween-80 (paragraph [261]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian Gulledge whose telephone number is (571) 270-5756. The examiner can normally be reached Monday - Friday 7am - 4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Brian Gulledge/Primary Examiner, Art Unit 1699
1 As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is “undue”, not “experimentation”.