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 .
Claim Status
Applicants’ amendments and arguments filed 11/21/2025 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claims 1-2, 7, and 13 are amended.
Claims 3 and 10 are cancelled.
Claims 12, 15-16, and 19 remain withdrawn.
Claims 20-23 are newly added.
Claims 1-2, 4-9, 11, 13-14, 17-18, and 20-23 are examined on the merits.
Claim Interpretation
Claim 1 utilizes the relative term "about". The term “about” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, thus rendering the claims broad. Therefore, the term “about” in claim 1 will be broadly interpreted by the examiner to mean +/- 10%.
In regards to claim 13, now recites the term “optionally”, which is interpreted by the examiner to mean any component following these terms in not a required claim limitation.
Furthermore, in regards to claim 13, the MPEP 2113 states "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). Therefore, since claim 13 is directed towards an extruded depot comprising an active substance, a biodegradable polymer, and a lipid, these components will be sufficient in meeting the limitations of this claim.
In regards to claim 14, the limitation of ‘the in vitro release of the peptide hormone is at least 20% by weight after 7 days and/or is at least 60% by weight after 28 days’ applicant is reminded this is a composition/product claim and the prior art teaches the limitations of the extruded depot composition of instant claim 1 for which claim 1 depends upon thereby since a product is not separable from its physical properties then it necessarily teaches the depot has an in vitro release profile of the peptide hormone is at least 20% by weight after 7 days and/or is at least 60% by weight after 28 days. Applicants observation that it also has the above release profile does not give it patentable weight, since it is the same composition as the anticipating art, as adding a characterization to a prior art patented invention is not patentable.
Maintained Rejections
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
(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.
Claims 1, 4-9, 11, 13-14, 17-18, and 20-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Partenhauser (WO2018172494A1, published 09/27/2018, English translation via Google, hereafter Partenhauser).
Partenhauser teaches an extruded depot form comprising at least one active substance, at least two compounds from the class of lipase-degradable substances comprising a low melting compound and a high melting compound (claim 1; according to the claim limitations of the instant claims 1, 9, and 13). Partenhauser teaches the concentration of the lipase-degradable substances and optionally one adjuvant for modulating fuel supply, to be at least 60% by of the dry weight of the depot form (claim 1; according to the claim limitations of the instant claim 1). Claim 3 of Partenhauser claims the both the low melting compound and high melting compound are selected from the class of fats, in particular mono-, di-, and/or triglycerides (according to the claim limitations of the instant claims 1, 4-5, and 9). Furthermore, Partenhauser teaches the high melting compound to have a melting point of from about 45 to about 75oC (page 4, paragraph 8; according to the claim limitations of the instant claim 1). Claim 5 of Partenhauser claims the adjuvant of drug release to be poly(D,L,-lactide-co-glycolide) (according to the claim limitations of the instant claims 1-2, 9, and 21). Partenhauser abbreviates poly(D,L-lactide-co-glycolide as PLGA (page 6, paragraph 1; according to the claim limitations of the instant claim 1). Partenhauser teaches the addition of calcium sulfate as a pore-forming agent (page 5, paragraph 10; according to the claim limitations of the instant claims 6 and 17). Partenhauser teaches the active substance is at least one active agent, without limitation, selected from the following group: peptide hormones, antidiabetics, a gonadotropin releasing hormone analogs, programmed cell death receptor 1, neuroleptics, DNA, plasmid DNA, cationic DNA complex, RNA, siRNA, mRNA, octreotide, somatotropin, bevacizumab, ranibizumab, exenatide, infliximab, trastuzumab, natalizumab, pembrolizumab, and risperidone (page 4 and 5, paragraph 12 and 1 respectively; according to the claim limitations of the instant claims 7-8 and 18). Furthermore, Partenhauser claims the following additional active agents: growth hormones, VEGF inhibitor, breast cancer therapeutics, multiple sclerosis therapeutics, paroxysmal hemoglobinuria protein drugs, (claim 6; according to the claim limitations of the instant claims 7-8 and 18). Claim 8 of Partenhauser claims the extruded depot form has a homogeneous core coating having a homogeneous composition of the components mentioned in claim 1 (i.e. lipase-degradable substance) (according to the claim limitations of the instant claim 9). Claim 9 of Partenhauser claims the extruded depot form mold has a length in the range of 0.1-5 cm (according to the claim limitations of the instant claim 1). Claim 10 of Partenhauser claims the extruded depot form has a diameter to length ratio of from about 1:30 to about 10:1 (according to the claim limitations of the instant claim 11). Lastly, Partenhauser provides the advantageous composition which teaches the concentration of PLGA to be from 1-79 wt.%, preferably 5-65 wt%, and the concentration of the low melting compound to be from 1 to 95 wt.%, preferably 10-89 wt.%, which calculates to a ratio of 79:1 to 1:95, preferably 6.5:1 to 1:17.8 (page 6, paragraph 5; according to the claim limitations of the instant claims 1, and 22-23). The same advantageous composition of Partenhauser teaches the active compound is at a concentration of 0.1 to 50% by weight (page 6, paragraph 5; according to the claim limitations of the instant claims 1 and 20).
New Rejections Necessitated by Amendments
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, 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.
Claim 7 has been amended to recite “wherein the at least one active substance is also at least one” which is unclear if this is further broadening the claim limitation of antidiabetic in claim 1 or adding in an additionally active substance, thus rendering the claim indefinite.
For the purpose of moving prosecution forward, Examiner broadly interprets the selected active substance of claim 1, antidiabetic, to meet these limitations.
Claim 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, 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.
Claim 13 uses the term “and/or” which is unclear as to whether the claim requires all of the listed components (i.e. sterilizing and packaging) or just one of the components individually or a combination of the components thereby rendering the claims indefinite.
Therefore, claim 13 will be broadly interpreted by the examiner to mean the claims optionally require just one of the components individually (i.e. sterilizing).
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 (i.e., changing from AIA to pre-AIA ) 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, 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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Partenhauser (WO2018172494A1, published 09/27/2018, English translation via Google, hereafter Partenhauser).
As outlined above, Partenhauser claims an extruded depot comprising the forementioned components of instant claim 1. Furthermore, Partenhauser teaches that it has also been found that the delivery of the at least one active substance from the deport form according to the invention can be improved when lactic acid based substances such as poly(glycolide-co-trimethylene carbonate), poly (glycolide-co-epsilon-caprolactone), poly(glycolide-co-caprolactone), and the like are contained in the depot form.
Partenhauser does not teach with sufficient specificity to anticipate claim 2 and so the claim is obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of Partenhauser with a reasonable expectation of success to obtain the extruded depot composition of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[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. A person of ordinary skill in the art who is not an automaton is capable of producing the composition of the instant claims with predictable results.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 6, 8-9, 11, and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-8, 10, and 17 of copending Application No. 17753589 (reference application) in view of over Partenhauser (WO2018172494A1, published 09/27/2018, English translation via Google, hereafter Partenhauser). Although the claims at issue are not identical, they are not patentably distinct from each other.
17753589 claims an extruded depot form comprising at least one active substance selected from nucleic acids; and at least one biodegradable organic polymer comprising at least one monomer selected from the group consisting of lactic acid and glycolic acid (claim 1; according to the claim limitations of the instant claim 1). Claim 1 of 17753589 claims the biodegradable polymer is at least one selected from the group consisting of poly(D,L-lactide and poly(D,L-lactide-co-glycolide) (according to the claim limitations of the instant claim 1). Claim 1 of 17753589 further claims the concentrations of the at least one active substance to be in an amount of 5% to 40% by weight (according to the claim limitations of the instant claim 1). Claim 3 of 17753589 claims at least one active substance is at least one selected from a group consisting of DNA, plasmid DNA, cationic DNA complex, RNA, siRNA, and mRNA (according to the claim limitations of the instant claims 1 and 8). Claim 5 of 17753589 claims the depot form comprises at least one lipid (according to the claim limitations of the instant claim 1). Claim 6 of 17753589 claims the depot form comprises at least one active substance, at least one biodegradable organic polymer, and at least one lipid comprising at least 50% by weight of the dry weight of the depot form (according to the claim limitations of the instant claim 1). Claims 7 and 17 of 17753589 claims the depot further comprising one or more excipients selected from the group consisting of an enzyme, polyethylene oxide, a salt with divalent metal ions, a disaccharide, an oligosaccharide, a polysaccharide, lipase, polyethylene glycol, calcium chloride, trehalose, a cyclodextrin, and cellulose (according to the claim limitations of the instant claims 6 and 17). Claim 8 of 17753589 claims the extruded depot form comprises a homogeneous core coating comprising a homogeneous composition of the at least one active substance and the at least one biodegradable organic polymer (according to the claim limitations of the instant claim 9). Claim 1 of 17753589 claims the extruded depot form has a length of 0.1-5cm (according to the claim limitations of the instant claim 11). Claim 10 of 17753589 claims the extruded depot form has a ratio of diameter to length of 1:30 to 10:1 (according to the claim limitations of the instant claim 11).
17753589 fails to teach the active substance is an antidiabetic as in instant claim 1. Further, although 17753589 teaches the composition comprises both at least one biodegradable organic polymer, and at least one lipid comprising at least 50% by weight of the dry weight of the depot form, it fails to explicitly teach the concentration ratio of the instant claim 1.
As outlined above, Partenhauser claims an extruded depot comprising an antidiabetic and/or nucleic acids, PLGA, a lipid (mono-, di-, or tri- glyceride) at the desired concentrations, ratios, and length to include the advantageous composition which teaches the concentration of PLGA to be from 1-79 wt.% and the concentration of the low melting compound to be from 1 to 95% by weight which calculates to a ratio of 79:1 to 95:1.
It would be obvious to one skilled in the art before the effective filing date of the claimed invention to claim an extruded depot form comprising at least one active substance, at least one biodegradable organic polymer (PLGA), and a lipid at the desired concentrations, ratios, and length as outlined by 17753589 with the simple substitution of one active substance known to be used in the same extruded form composition interchangeably, RNA and an antidiabetic, as outlined by Partenhauser. Simple substitution of one active substance known to be used interchangeably for another is within the purview of the skilled artisan and would yield predictable results. Furthermore, One of ordinary skill in the art would know how to optimize the ranges of 17753589, as the MPEP 2144.05 states “Where 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.”
Response to Applicant’s Arguments
Applicant’s arguments and Affidavit submitted on 11/21/2025 have been considered by the examiner.
In regards to Applicant’s arguments against the claim interpretation of instant claim 14, Applicant argues that claim 14 is directed towards a property of the extruded depot form and is not intended use. Examiner argues with Applicant’s assertion and a new claim interpretation has been presented. As outlined above and again presented here, Applicant is reminded this is a composition/product claim and the prior art teaches the limitations of the extruded depot composition of instant claim 1 for which claim 1 depends upon thereby since a product is not separable from its physical properties then it necessarily teaches the depot has an in vitro release profile of the peptide hormone is at least 20% by weight after 7 days and/or is at least 60% by weight after 28 days. Applicants observation that it also has the above release profile does not give it patentable weight, since it is the same composition as the anticipating art, as adding a characterization to a prior art patented invention is not patentable.
In regards to Applicant’s arguments against the 35 U.S.C. 102 rejection, Applicant argues that Partenhauser does not disclose an extruded depot form having a specific example wherein the at least one active substance is an antidiabetic comprising 20-50 %of the dry weight depot form and at least one biodegradable organic polymer selected from a group to include the elected poly(D,L-lactide-coglycolide). Additionally, Applicant argues the Declaration submitted on 11/21/2025 outlines advantageous performance with respect to both release kinetics and mechanical stability, resulting in an unexpected result. The Declaration provides opinion from Eric Wittchow, who claims the inventive depot exhibits both enhanced release kinetics and improved mechanical stability due to the polymer:lipid ratio and the selected group of polymers.
In regards to Applicant’s argument that Partenhauser does not teach the limitations of the instant claim 1, Applicant is encouraged to review the Partenhauser and the 102 rejection above which demonstrates that Partenhauser teaches a sample composition with from 0.1-50% by weight of active compound and poly (D,L,-lactide-coglycolide) at a concentration of 1-79% (page 6, paragraph 4). Further, Partenhauser claims the active substance to be an antidiabetic as outlined in the 102 rejection above.
In regards to the Declaration, Examiner has reviewed Applicant’s ‘opinion’ and while considered, has not found it to be persuasive to overcome a 102 rejection, and further the newly added 103 as necessitated by amendment because applicant has not distinguished their invention over that of the prior art with sufficient structural features, further while the opinion is appreciated, in absence of factual data and comparison on the record the 103 is newly made and also not persuasive. With respect to the 103 and declaration evidence per the MPEP 716.02(b)(I), “I. BURDEN ON APPLICANT TO ESTABLISH RESULTS ARE UNEXPECTED AND SIGNIFICANT. The evidence relied upon should establish “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.” Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength “are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration.”); Ex parte C, 27 USPQ2d 1492 (Bd. Pat. App. & Inter. 1992) (Applicant alleged unexpected results with regard to the claimed soybean plant, however there was no basis for judging the practical significance of data with regard to maturity date, flowering date, flower color, or height of the plant.). See also In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977) and In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) as discussed in MPEP § 716.02(c).” Furthermore, it is noted that per 37 CFR 1.131(a)(II), Affidavits or Declarations are inappropriate in the follow situations: (A) Where the application is subject to current 35 U.S.C. 102 and the affidavit or declaration is not directed to evidence used in a rejection based on pre-AIA 35 U.S.C. 102(g). (B) Where the reference publication date is more than 1 year prior to the effective filing date of applicant’s or patent owner’s claimed invention. Such a reference is a “statutory bar” under pre-AIA 35 U.S.C. 102(b) as referenced in 37 CFR 1.131(a)(2). A reference that only qualifies as prior art under pre-AIA 35 U.S.C. 102(a) or (e) is not a “statutory bar.”
Therefore, Examiner is not persuaded by Applicant’s arguments and the 35 U.S.C. 102 rejection is maintained and updated to include the amendments.
In regards to Applicant’s arguments against the Non-Statutory Double Patenting rejection, Applicant argues that 17753589 does not teach the limitation of “a ratio of at least one compound from the class of biodegradable organic polymers and a second compound from the class of lipids is from about 25:1 to about 5:1”.
Examiner agrees that 17753589 fails to teach the limitation of “a ratio of at least one compound from the class of biodegradable organic polymers and a second compound from the class of lipids is from about 25:1 to about 5:1” and the previous rejection of record has been withdrawn. A new grounds of rejection due to claim amendments has been presented above.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA NICOLE ISNOR whose telephone number is (703)756-5561. The examiner can normally be reached Monday-Friday 5:30am-3pm PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at (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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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.N.I./Examiner, Art Unit 1611