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 .
DETAILED ACTION
Status of claims
The amendment filed on June 19, 2026 is acknowledged. Claims 20, 33, 36, 40, 44, 57, 63, 65, 67, 69, and 71 have been withdrawn. Claims 1, 7-8, 15, 19, 46-47, and 55 are under examination in the instant office action.
Applicants' arguments, filed on June 19, 2026, have been fully considered but they are not deemed to be persuasive or moot in view of new ground of rejection necessitated by the amendments in claim 1. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claim 1 is objected to because of the following informalities: typographical errors. The definite article --the-- should be inserted before “microparticles in line 5.
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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 7-8 and 15 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 7 recites “the particles are “microparticle” and claim 8 recites “the microparticles have a diameter of about 1 to about 100 microns”. However, claim 1 from which claims 7-8 are dependent has been amended to recite “microparticle” and “the microparticles have a diameter of about 1 to about 100 microns”. Thus, they fail to further limit the subject matter of the claim 1.
Also, claim 15 recites “the SARM is released for up to 10 weeks. However, claim 1 from which claim 15 is dependent has been amended to recite “the SARM is released from the microparticles in a sustained manner over a period of about 4 weeks”, which is narrower range than the range recited in claim 15. Thus, it fails to further limit the subject matter of the claim 1.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
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 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.
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.
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.
Claims 1, 7-8, 15, 19, 46-47, and 55 are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0107088 (hereafter, Wilsey) in view of US2004/0224030 (hereafter, Shastri; cited in the IDS filed on 2/7/2024) in further view of US 2020/0352869.
Wilsey teaches an implantable medical device comprising a drug depot that releases the anabolic agent over at least 2 days (sustained release), wherein the drug depot comprises an anabolic agent such as selective androgen receptor modulators (SARMs), a biodegradable polymer, and a suitable pharmaceutical carrier (abstract, [0013], [0042], [0133], [0135], and claim 1, 7-9). The SARMs comprises (2S)-3-(4-cyanophenoxy)-N-[4-cyano-3-(trifluoromethyl)phenyl]-2-hydroxy-2-methylpropanamide)(ostarine) ([0042] and claim 7), which is the elected compound (
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Wilsey further teaches that the at least one biodegradable polymer comprises PLGA and comprises at least 40 wt. %, at least 45 wt. %, at least 50 wt. %, at least 55 wt. %, at least 60 wt. %, at least 70 wt. %, at least 80 wt. %, at least 85 wt. %, at least 90 wt. %, at least 95 wt. % or at least 97 wt. % of the formulation ([0159], [0165], and claims 8-9). The range of the polymer overlaps the range recited in claim 1
Wilsey also teaches that the medical device (e.g., drug depot) may be designed for sustained release ([0022]) and the phrases "sustained release" and "sustain release" (also referred to as extended release or controlled release) are used herein to refer to one or more therapeutic agent(s) that is introduced into the body of a human or other mammal and continuously or continually releases a stream of one or more therapeutic agents over a predetermined time period and at a therapeutic level sufficient to achieve a desired therapeutic effect throughout the predetermined time period ([0025]).
In addition, Wilsey teaches that the anabolic agent is encapsulated in a plurality of depots comprising microparticles, microspheres, microcapsules, and/or microfibers and the drug particle size (e.g., anabolic agent) in the depot is from about 1 to about 25 micrometers, or about 5 to 50 micrometers ([0135], [0058] and [0162]). The range of the particle size falls within the range recited in claim 1.
Wilsey further teaches that the anabolic agent may be in a polymer-based depot administered by continuous infusion through a pump (injectable formulation) ([0124] and claim 20).
The specific combination of features claimed is disclosed within the broad genera of taught by Wilsey, but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any motivation to select this specific combination of variables, anticipation cannot be found.
That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected various combinations of the selective androgen receptor modulators and biodegradable polymers within the disclosure of Wilsey for preparing a sustained release depot (microparticles) composition to arrive at compositions “yielding no more than one would expect from such an arrangement”. As stated above, Wilsey specifically discloses and claims the elected compound as one of selective androgen receptor modulators and PLGA as one of suitable biodegradable polymers for their sustained release formulation. While it does not specifically disclose an example of sustained release depot (microparticles) composition comprising the elected compound and PLGA, one of ordinary skill in the art would have envisaged such formulation and have been motivated to prepare it with a reasonable expectation of success since such combination has been taught and suggested by the prior art.
In addition, Shastri discloses a controlled release formulation containing microspheres (microparticle) comprising blended PLGA copolymers and a biologically active agent, which have controlled release profiles, preferably delayed release profiles, providing prolonged release of a biologically active agent (abstract and [0003]). Shastri teaches that any agent having therapeutic biological activity may be included in the microspheres ([0007] and [0058]) and the timing, rate, quantity, and/or duration of release of a biologically active agent from a microsphere can be controlled or modulated by optimization of the microsphere copolymer ratio ([0027]). Shastri further teaches methods of controlling the duration of release of a biologically active agent from a microsphere by controlling the type and/or ratio of PLGA copolymer ([0050]). For example, the release period of PLGA copolymer having a 75%:25% ratio of racemic lactide DL to glycolide (RG75/25) can continue for more than 7 weeks ([0006] and [0051]). Shastri further teaches that the microspheres fall within the range of 30 to 40 micrometers and the diameter of the microsphere is modulated depending on the desired alteration in release kinetics ([0039]). The range falls within the range recited in claim 1. Shastri also teaches that an important factor in the successful treatment of long-term chronic disease, such as osteoporosis, diabetes, asthma, hepatitis, and arteriosclerosis etc., is patient compliance to the prescribed treatment regimen and PLGA microspheres with controlled release profiles can be implanted into a site in vivo by injection, thereby requiring fewer doses and increasing patient compliance ([0002] and [0028]).
Thus, the skilled artisan would have been further motivated to prepare a sustained release formulation comprising the SARM using PLGA microspheres as taught by Shastri because Shastri teaches the PLGA microspheres with controlled release profiles can be used for any therapeutic agent and can controlling the duration of release of a biologically active agent from a microsphere by controlling the type and/or ratio of PLGA copolymer. The skilled artisan would have been motivated to use PLGA microspheres as taught by Shastri for prolonged release of SARM in the treatments of a long-term chronic disease on the reasonable expectation that the resulting sustained release formulation could be implanted into a site in vivo by injection, thereby requiring fewer doses and increasing patient compliance as taught by Shastri.
As to the percentage of the polymer, Wilsey teaches the range overlapping the claimed rage. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F. 2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
As to the time period of release (about 4 weeks or for up to 10 weeks) recited in amended claim 1 and claim 15, Wilsey teaches that the phrases "sustained release" and "sustain release" (also referred to as extended release or controlled release) are used herein to refer to one or more therapeutic agent(s) that is introduced into the body of a human or other mammal and continuously or continually releases a stream of one or more therapeutic agents over a predetermined time period and at a therapeutic level sufficient to achieve a desired therapeutic effect throughout the predetermined time period ([0025]). Also, Shastri teaches the duration of release of a biologically active agent from a microsphere can be optimized by controlling the type and/or ratio of PLGA copolymer that comprises the microsphere and the release period of PLGA copolymer having a 75%:25% ratio of racemic lactide DL to glycolide (RG75/25) can continue for more than 7 weeks ([0006] and [0051]). Shastri further teaches that the diameter of the microsphere also can be modulated depending on the desired alteration in release kinetics ([0039]).
In addition, it was well-known in the art to prepare injectable formulations for sustained release of active agents by using PLGA microparticles with 20-50 μm size, wherein the sustained release target period is 14-28 days (2-4 weeks) as evidenced by US 2020/0352869 (abstract, [0016], [0050] and [0067]). US 2020/0352869 further teaches that longer periods than 28 days (4 weeks) would increase the risk of not being able to address any unexpected reactions or issues the patient may experience due to the drug ([0067]).
Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the time period to release the active agent for achieving a desired therapeutic effect throughout the predetermined time period by adjusting the type and/or ratio of PLGA copolymer and the diameter of microspheres as taught by Shastri. Also, the skilled artisan would have been motivated to prepare PLGA microparticles which release the SARM of over a period of about 4 weeks for addressing any unexpected reactions or issues the patient may experience due to the drug as taught by US 2020/0352869.
In addition, it is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”)
Response to Applicant’s arguments
Responses are limited to Applicants' arguments relevant to either reiterated or newly applied rejections.
Applicant argued that Shastri is directed to a different class of therapeutic agents and a different therapeutic context.
In response, while specific examples disclosed in Shastri may comprise hydrophilic peptides or protein, "biologically active agent in Shastri is not limited to such peptide, but encompasses natural or synthetic chemical compounds (see [0013]). A reference is not limited to its working examples, but must be evaluated for what it teaches those of ordinary skill in the art. In re Boe, 355 F.2d 961, 148 USPQ 507 (C.C.P.A 1966). In re Chapman, 357 F.2d 418, 148 USPQ 711 (C.C.P.A. 1966).
Applicant further argued that enobosarm is hydrophobic, and the present specification adopted its emulsion process specifically on that basis, stating that "a single (oil-in-water) emulsion solvent evaporation technique was selected to prepare the SARM-loaded PLGA microparticles and this method was chosen due to the hydrophobic nature of SARM". However, such feature is not recited in the claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Also, it should be noted that the claims are not limited to hydrophobic compounds such as enobosarm, but encompass any selective SARM compounds, which have different physical and chemical properties.
In response, the Examiner respectfully submits that the above rejection is based on a combination of references, not on Wilsey taken in a vacuum. As such, Applicants' arguments pertaining to Wilsey are not persuasive. 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).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See MPEP 2145(X)(A) (citing In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971)). As set forth in the rejection of the claims, the combination of each teaching was properly motivated by a rationale derived independently of applicant’s disclosure.
For the foregoing reasons, Applicant’s arguments have not been found to be persuasive.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONG-SOOK BAEK whose telephone number is 571-270-5863. The examiner can normally be reached 9:00AM-6:00PM Monday-Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611
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