DETAILED ACTION
Receipt is acknowledged of applicant’s Response to Restriction Requirement filed 8/11/2025.
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 the Claims
Claims 1-19 are pending.
Election/Restrictions
Applicant’s election of Group I (claims 1-9) in the reply filed on 8/11/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 10-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Accordingly, claims 1-9 are currently under examination.
Information Disclosure Statement
The IDS’s filed 3/19/2024, 4/9/2024, 5/2/2024 and 6/18/2024 have been considered. Signed copies are enclosed herewith.
Specification
The use of the terms Decadron®, Celebrex® and Vioxx®, which are trade names or marks used in commerce, have been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 1 and 2 are objected to because of the following informalities: Claims 1 and 2 recite, “an average diameter Dp greater than 1 micron and less than the least of 1000 micron”. The phrase, “1000 micron” should recite “1000 microns”.
Claim 2 is objected to because of the following informalities: the claim recites, “apical”, “boundary” and “basal” (in quotations) at lines 20-23 of the claim. The quotations are superfluous as each of the limitations have been set out earlier in the claim. It is suggested that the quotations are removed.
Claim 3 is objected to because of the following informalities: the claim recites, “Endothelial Growth Factor”, “Transforming Growth Factor”, “Fibroblast Growth Factor” “Platelet-Derived Growth Factor”, “Vascular Endothelial Growth Factor”, “ and “Interleukins”. Each of the aforementioned terms should be in lowercase form. The claim also recites, “keratinocyte GF”. It is suggested that “GF” is written out in its expanded form.
Claim 5 is objected to because of the following informalities: the claim recites, “Dexamethasone Sodium phosphate” in line 4 of the claim. “Dexamethasone” and “Sodium” should be in lowercase form.
Claim 7 is objected to because of the following informalities: the claim recites, “Polydopamine”, “Poly(D,L-lactic acid)”, “Poly(L-lactic acid)”, Poly(D-lactic acid)”, and “Polycaprolactone”. Each of the aforementioned terms should be in lowercase form, e.g., “poly(D,L-lactic acid).
Appropriate correction is requested.
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 1-9 are rejected under 35 U.S.C. 101 because claimed invention is not directed to patent eligible subject matter.
Based upon consideration of all of the relevant factors with respect to the claims as a whole, said claims are determined to be directed to an abstract idea. The rationale for this determination is explained below. The instant claims are drawn to a method for controlled ballistic delivery of a biologically active cargo to a bilayer tissue of an individual.
There are two criteria for determining subject matter eligibility and both must be satisfied, 1) the claimed invention must be directed to one of the four statutory categories and 2) the claimed invention must not be wholly directed to subject matter encompassing a judicially recognized exception (MPEP 2106). The four categories of statutory subject matter are process, machine, manufacture and composition of matter (MPEP 2016). The claimed invention most closely resembles a process (i.e., an act, or a series of acts or steps performed upon the subject-matter to be transformed and reduced to a different state or thing"). However, the claimed method steps of selecting a target region based on target region thickness calculations, determining a target penetration distance, and determining a velocity of the substantially spherical particles (instant claim 1) fail to transform or reduce the claimed polymers and active agents into a different state or thing. Regarding judicial exceptions, MPEP 2106 states, “Determining whether the claim falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter) does not end the analysis because claims directed to nothing more than abstract ideas (such as mathematical algorithms), natural phenomena, and laws of nature are not eligible for patent protection.” Factors that are considered in an abstract idea determination of a method claim include (a) whether the method involves or is executed by a particular machine or apparatus, (b) whether performance of the claimed method results in or otherwise involves a transformation of a particular article, (c) whether performance of the claimed method involves an application of a law of nature, even in the absence of a particular machine, apparatus or transformation and (d) whether a general concept is involved in executing the steps of the method. MPEP 2106 states that the presence of a general concept can be a clue that the claim in drawn to an abstract idea. Such concepts include mathematical concepts (e.g. algorithms, spatial relationships, geometry) and mental activities (e.g., forming a judgment, observation, evaluation, or opinion). The instant claims involve selecting a target region based on target region thickness calculations, determining a target penetration distance, and determining a velocity of the substantially spherical particles. Said steps are rooted in mathematic calculations and based on the properties of the target tissue and the (polymeric) particles comprising a bioactive agent and said generating step involves mathematics as well as mental steps. Furthermore, the method does not result in the transformation (i.e. change to a different state or thing) of a particular article (i.e. physical object or substance). The method yields the identification of formulations, but does not yield a formulation itself. Therefore, the two criteria for determining subject matter eligibility: 1) the claimed invention must be directed to one of the four statutory categories and 2) the claimed invention must not be wholly directed to subject matter encompassing a judicially recognized exception, are not met and, as such, the claimed subject matter is not patentably eligible.
It is noted that depending claims 2-9 are rejected under 35 USC 101 because said depending claims involve the same ineligible subject matter as independent claim 1 and do not provide any additional subject matter that would place the claims in eligible form.
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 1-9 are 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.
Claims 1 and 2 recite, “an average diameter Dp greater than 1 micron and less than the least of 1000 micron”. The phrase “less than the least of 1000 microns” renders the claims indefinite because the claims are unclear and confusing. The metes and bounds of the claims cannot be readily ascertained. Dependent claims 3-9 do not remedy the indefinite issue and as such said dependent claims suffer from the same deficiency.
Claims 3-8 each recite the limitation, “selected from the group comprising”. MPEP 2173.05(h) states,
A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group "comprising" or "consisting essentially of" the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim.
Accordingly, the claims are indefinite because it is unclear if each grouping is a closed group of alternatives to only those recited or if additional alternatives are encompassed or permitted.
Claim 5 contains the trademark/trade name Decadron®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe dexamethasone and, accordingly, the identification/description is indefinite.
Claim 6 contains the trademark/trade names Celebrex® and Vioxx®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade names are used to identify/describe celexoxib and refecoxib, respectively, and, accordingly, the identification/description is indefinite.
Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Rinberg et al. “Pneumatic capillary gun for ballistic delivery of microparticles”, Applied Physics Letters 87(1), February 2005, 8 pages; hereafter as “Rinberg”. Rinberg teaches ballistic delivery of microparticles into tissue, said particles are gold and coated with a bioactive (GFP expressing reporter plasmid).
Groisman et al., US 2008/0206870 A1, Aug. 28, 2008, hereafter as “Groisman”. Groisman teaches ballistic delivery of micron-sized particles into tissue. Groisman teaches that the particles are preferably gold or tungsten and genetic material (DNA, RNA, or plasmids) or dyes can be coated on said particles.
Borovkov et al., US 2009/0175949 A1, Jul. 9, 2009, hereafter as “Borovkov”. Borovkov teaches delivery of microparticles comprising bioactive molecules to organelles, cells, tissues or animals via ballistic administration. Borovkov teaches said microparticles can include polymers. Borokov teaches bioactive molecules include nucleic acids (i.e. DNA, RNA, siRNA, mRNA, miRNA or antisense nucleotides), proteins, peptides, lipids, polysaccharides, metabolites, drugs, molecular complexes, and macromolecular structures.
Kendall et al., “Transdermal Ballistic Delivery of Micro-Particles: Investigation into Skin Penetration”, Proceedings of the 22nd Annual EMBS International Conference, July 2000, Chicago, IL, pp. 1621-1624, vol. 3; hereafter as “Kendall”). Kendall teaches transdermal ballistic delivery of micro-particles. Kendall teaches said microparticles comprise glass, polystyrene or steel and are useful for the delivery of vaccines, proteins and topical drugs.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
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/CASEY S HAGOPIAN/Examiner, Art Unit 1617