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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/07/2025 is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 22-23, 25, 29, 33-34, 49, and 53 in the reply filed on 10/27/2025 is acknowledged.
Claim Interpretation
Claim 22 recites the limitation/step of “b. optionally removing”, specifically the step is directed towards the term “optionally”, which is interpreted by the examiner to mean any component following these terms in not a required claim limitation.
In regards to claim 33, it is noted that this is a method for stabilizing a biological macromolecule comprising a mixture (i.e. a product by process) claim and the prior art teaches a composition and process for forming said composition described by applicants instant application. Thereby since a product is not separable from its physical properties then it necessarily teaches the mixture having a pH of at least about 6.8. Applicants observation that it also has ‘a pH of at least about 6.8’ does not give it patentable weight, since it is the same composition and same process of making, as adding a characterization to a prior art patented invention is not patentable.
Claim 33 recites the relative term limitation of “about” which is not defined by the claims. Further, Applicant’s specification provides numerous definitions for the term “about” to include the following: “In certain embodiments, "about" can mean within 3 or more than 3 standard deviations, per the practice in the art. In certain embodiments, such as with respect to biological systems or processes, the term can mean within an order of magnitude, including within 5 -fold, and within 2- fold of a value. In certain embodiments, when the term "about" or "approximately" is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and below those numerical values. In general, the term "about" is used herein to modify a numerical value above and below the stated value by a variance of 20%, 10%, 5%, or 1%. In certain embodiments, the term "about" is used to modify a numerical value above and below the stated value by a variance of 10%. In certain embodiments, the term "about" is used to modify a numerical value above and below the stated value by a variance of 5%. In certain embodiments, the term "about" is used to modify a numerical value above and below the stated value by a variance of 1%” ([0091]). Due to Applicant’s broad definitions, claim 33 will be broadly interpreted by the examiner to mean +/- 20%.
In regards to claim 49, it is noted that this is a product by process claim for the product of a method for stabilizing a biological macromolecule comprising a mixture. Therefore, any prior art teaching the method of claim 22 in which claim 49 depends upon will teach the limitations of the claim 49.
In regards to claim 53, it is noted that this is directed towards the product of a method for stabilizing a biological macromolecule comprising a mixture (i.e. a product by process) claim and the prior art teaches a composition and process for forming said composition described by applicants instant application. Thereby since a product is not separable from its physical properties then it necessarily teaches the formulation remains at least 90% active after six months at room temperature. Applicants observation that it also ‘remains at least 90% active after six months at room temperature’ does not give it patentable weight, since it is the same composition and same process of making, as adding a characterization to a prior art patented invention is not patentable.
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.
Claims 33 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 33 is dependent upon claim 22 which recites step “a. creating a mixture” and step “c. lyophilizing the mixture”. Claim 33 then recites “the mixture comprises” which is unclear as to which step the “modified simulated body fluid (mSBF)” of claim 33 is added (i.e. is it added before or after the lyophilizing).
Therefore, in order to move prosecution forward, Examiner broadly interprets this limitation to be met by the mixture of modified simulated body fluid to be added at any step.
Claims 34 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 34 is dependent upon claim 22 which recites step “a. creating a mixture” and step “c. lyophilizing the mixture”. Claim 34 then recites “wherein the mixture has” which is unclear as to which mixture (the mixture of step a or c) has a “pH of at least about 6.8” thus rendering the claim indefinite.
As mentioned above in the claim interpretation of claim 34, Examiner broadly interprets the claim to be physical properties of the process and product, thereby any prior art satisfying the limitations of claim 22 will satisfy the limitations of claim 34.
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.
Claims 22-23, 25, 29, 33-34, 49, and 53 are rejected under 35 U.S.C. 103 as being unpatentable . (Yu X, Khalil A, Dang PN, Alsberg E, Murphy WL. Multilayered Inorganic Microparticles for Tunable Dual Growth Factor Delivery. Adv Funct Mater. 2014 May 28;24(20):3082-3093. doi: 10.1002/adfm.201302859. PMID: 25342948; PMCID: PMC4204399., hereafter Yu), and as evidenced by Yu supporting document (Yu X, Khalil A, Dang PN, Alsberg E, Murphy WL. Multilayered Inorganic Microparticles for Tunable Dual Growth Factor Delivery. Adv Funct Mater. 2014 May 28;24(20):3082-3093. doi: 10.1002/adfm.201302859. PMID: 25342948; PMCID: PMC4204399. – supporting document provided by Wiley, hereafter Yu supporting document).
As evidenced by the Yu supporting document, the modified simulated body fluid (mSBF) used in Yu contains 5.0 mM of CaCl2 and 2.0 mM of KH2PO4 (Table S-1).
Yu teaches a multilayered inorganic microparticles, specifically mineral coated micro-particles (MCMs)(title and abstract; according to the claim limitations of the instant claim 22). Yu further teaches bone morphogenetic protein-2 (BMP-2) and vascular endothelial growth factor(VEGF) are bound to the mineral coatings (abstract; according to the claim limitations of the instant claims 22 and 29). Yu teaches the incorporation of dual growth factor into MCMs, by binding BMP-2 and VEGF to the surface of the MCMs then washing and lyophilizing the mixture (page 10-11, Dual Growth Factor Incorporation into MCMs; according to the claim limitations of the instant claim 22). After lyophilization, Yu teaches the mixture is then incubated in phosphate buffered saline (PBS) and in modified simulated body fluid (mSBF) (page 10-11, Dual Growth Factor Incorporation into MCMs; according to the claim limitations of the instant claims 23, 25, and 33). Yu teaches that the pH of the mSBFs was then adjusted to 6.8 (page 9, 5. Experimental Section; according to the claim limitations of the instant claim 34). Further, Yu teaches the stability of MCMs is monitored (page 10, MCMs characterization; according to the claim limitations of the instant claim 22). Yu teaches that both the morphology and stability of the mineral coatings was affected and resulted in significant decelerated dissolution of the mineral coating (page 4, 2.2, Control..; according to the claim limitation of the instant claim 22).
Yu does not teach with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of Yeo with a reasonable expectation of success to obtain the method 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 method 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 49-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 5 of U.S. Patent No. 12,465,654. Although the claims at issue are not identical, they are not patentably distinct from each other.
16500017 claims a formulation comprising a mineral coated microparticle comprising a core and a mineral coating; and at least a second active agent bound to the mineral coated mineral coated microparticle (claim 1; according to the claim limitations of the instant claims 49-50). 16500017 claims the second bound active agent is absorbed to the mineral coating (claims 2 and 5; according to the claim limitations of the instant claims 49-50). Claim 1 of 16500017 further claims the second active agent to be an IL-1 antagonist (according to the claim limitations of the instant claim 1).
16500017 does not teach with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of Yeo with a reasonable expectation of success to obtain the formulation 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 formulation of the instant claims with predictable results.
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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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.N.I./ Examiner, Art Unit 1611