DETAILED ACTION
The receipt is acknowledged of applicant’s IDS filed 09/16/2022; and election and amendment filed 08/28/2025.
Claims 1-20 previously presented and were subject of Election/Restriction requirement. Claims 1-20 have been canceled, and new claims 21-39 have been added by the amendment filed in response to election/restriction requirement filed 08/28/2025.
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 .
Election/Restrictions
Applicant's election with traverse of Invention I in the reply filed on 08/28/2025 is acknowledged. The traversal is on the ground(s) that inventions I though IV all relate to single general inventive concept and all have the same technical features. However, in view of the amendment and presented new claims, and in order to advance the prosecution, the examiner will examiner invention I through III, claims 21-34, directed to two products and method of their use. The presented argument regarding invention IV is not found persuasive because the method of claim 35 requires determining the dilution ratio of cannabinoid solution, and require applying the solution to internal site of injury, while claims 21-34 do not require dilution of the cannabinoid nor solution, rather the product and its method of used claimed by claims 21-34 require foam or patch.
The requirement is still deemed proper and is therefore made FINAL.
Claims 35-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention IV, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 08/28/2025.
Claim Rejections - 35 USC § 112 (a)
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.
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 22 and 34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 22 recites carrier material that is configured to be applied to internal injury site. Claim 34 recites groups of neurological disorders to be treated by application of carrier material to internal injury sites.
Regarding claim 22, nowhere applicant had disclosed or described food applied to the site of injury to treat internal injury.
Regarding claim 34, while applicant listed the claimed disorders in the specification, however no description on how the medical carrier when applied to an injured site would treat these disorders. The claimed disorders are not described as related by any way to injury. For example, brain tumors have etiology not related to injury, and may require chemotherapy or radiotherapy, or even surgical removal. Same for paralysis that can be caused by stroke and need medical treatment with anticoagulant, or even may need surgical interference to remove the clot, or may require just physical therapy. Another example is the claimed autoimmune disorders, e.g. lateral sclerosis, the treatment may involve immunosuppressive medication. Regarding Alzheimer and Parkinsonism, these neurodegenerative disorders require specific classed of drugs known and described in the medicine. Therefore, applicant failed to describe how to treat the claimed disorders, and did not show any of these disorders was actually treated by the claimed medical carrier.
Federal Circuit decision in Ariad Pharmaceuticals, Inc v. Eli Lilly. 598 F. 3d 1336 - Court of Appeals, Federal Circuit, 2010 – It explains that the written description requirement applies to both original and amended claims. It had further explained that the test for written description is “possession as shown in the disclosure” and embraced past ways for judging the adequacy of the disclosure, including whether the specification discloses a representative number of species, sufficient structure, and/or a sufficient correlation of function to structure.
Written description requirement, "serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed.Cir. 2005). The requirement "serves a teaching function, as a quid pro quo in which the public is given meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time." Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 922 (Fed.Cir.2004) (quoting Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 970 (Fed.Cir.2002)); see O'Reilly v. Morse, 56 U.S. (15 How.) 62, 121, 14 L.Ed. 601 (1853) (explaining that a patentee "can lawfully claim only what he has invented and described, and if he claims more his patent is void"); Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345-46 (Fed.Cir.2000) ("The purpose of [the written description requirement] is to ensure that the scope of the right to exclude . . . does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.").
"To satisfy the written description requirement, `the applicant does not have to utilize any particular form of disclosure to describe the subject matter claimed, but the description must clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed.'" Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541 F.3d 1115, 1122 (Fed.Cir.2008) (quoting In re Alton, 76 F.3d 1168, 1172 (Fed.Cir.1996)). "In other words, the applicant must `convey with reasonable clarity to those skilled in 1372*1372 the art that, as of the filing date sought, he or she was in possession of the invention,' and demonstrate that by disclosure in the specification of the patent." Id. (quoting Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed.Cir.1991)). Such disclosure need not recite the claimed invention in haec verba, but it must do more than merely disclose that which would render the claimed invention obvious. Rochester, 358 F.3d at 923; Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1566-67 (Fed.Cir.1997); see also PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1306-07 (Fed.Cir.2008) (explaining that § 112, ¶ 1 "requires that the written description actually or inherently disclose the claim element").
"Whether the written description requirement is satisfied is a fact-based inquiry that will depend on the nature of the claimed invention and the knowledge of one skilled in the art at the time an invention is made and a patent application is filed." Carnegie Mellon, 541 F.3d at 1122 (citing Enzo, 323 F.3d at 963). The written description requirement is not satisfied by "[t]he appearance of mere indistinct words in a specification or a claim, even an original claim. . . . A description of what a material does, rather than of what it is, usually does not suffice." Enzo, 323 F.3d at 968 (citing Eli Lilly, 119 F.3d at 1568); see Rochester, 358 F.3d at 926 ("[G]eneralized language may not suffice if it does not convey the detailed identity of an invention.").
The same is true for both process claims and composition claims. Rochester, 358 F.3d at 926 ("Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods,"). Where the specification provides only constructive examples in lieu of working examples, it must still "describe the claimed subject matter in terms that establish that the applicant was in possession of the claimed invention, including all of the elements and limitations." Id. (citing Hyatt v. Boone, 146 F.3d 1348, 1353 (Fed.Cir. 1998)). Of course, what is adequate depends upon the context of the claimed invention. See Capon, 418 F.3d at 1358 ("The written description requirement must be applied in the context of the particular invention and state of the knowledge."). It further states that “We have articulated a variety of factors to evaluate the adequacy of the disclosure supporting "generic claims to biological subject matter." Id. at 1359. These factors include "the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, [and] the predictability of the aspect at issue." Id”.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See, e.g., In re Wilder, 22 USPQ 369, 372-3 (Fed. Cir. 1984). (Holding that a claim was not adequately described because the specification did ‘little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.’)
Claim Rejections - 35 USC § 112 (b)
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 22 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 22 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of medical carrier is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the claimed member of the Markush group includes gelatin, polysaccharides, polymer, e.g. polyglycolide, nanoparticles, and also include food that does not belong to the other claimed members.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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.
The factual inquiries 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.
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.
Claims 21-34 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Bevier (US 2014/0302121, currently cited on PTO 892) and Kleidon (US 2019/0247358, IDS filed 09/16/2022).
Applicant Claims
Claim 21 is directed to an application device comprising a bio-absorbable medical carrier, wherein the medical carrier contains at least one of purified cannabidiol and a cannabinoid mixture, and further wherein the medical carrier is configured for an internal injury site.
Claim 29 is directed to a medical carrier device for the transfer of cannabidiol to the surface of an internal injury site, comprising:
at least one of purified cannabidiol and a cannabinoid mixture; and
an absorbable medical carrier, wherein the medical carrier is configured for internal use.
Claim 32 is directed to a method of treating an internal injury site, comprising:
applying a bio-absorbable medical carrier comprising at least one of purified cannabidiol and a cannabinoid mixture to an internal injury site, wherein the absorbable medical carrier adjusts to the surface size of the internal injury site.
Regarding claims 21 and 29 that are directed to product, the claims recite the intended use of the claimed product for application to internal injury site. The recitation of intended us of the product/composition does not impart patentability to the claims. However, for completeness of record, the intended use will addressed in this rejection.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Bevier teaches product comprising cannabinoid receptor binding agents in nanoparticles form, and a substrate for local administration (abstract; ¶ 0004). The cannabinoid receptor binding agents are natural extract from cannabis including cannabinoid and cannabidiol (¶¶ 0027-0029, 0119, 0120, 0206; claim 12). The nanoparticles are incorporated in solid or gel carrier, hydrogel, or substrate (¶¶ 0059, 0061, 0110). The reference teaches topical delivery of the composition on a surface of an internal organ in form of patch or foam, or substrate of polymeric material that solidify on the surface of an organ (¶¶ 0063, 0065, 0066, 0083, 0084). The polymeric substrate material comprises polymers, e.g. polyglycolic acid, polysaccharide or gelatin that dissolve and soluble in aqueous environment (¶¶ 0038, 0085-0086, 0174; claims 1, 5). The reference teaches purified extracted cannabidiol (¶ 0206).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Brevier teaches all the elements of the claimed product as claimed by claims 21 and 29, the reference does not teach single embodiment including all the elements. As such, the instant prior art does not appear to provide sufficient specificity, i.e., involves some “picking and choosing” to give rise to anticipation. See, Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). That being said, 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.... the combination is obvious”. KSRv. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)).
While Bevier teaches the medical device as claimed by claims 21 and 29 comprising purified cannabidiol or cannabinoids and a carrier for in situ application to the surface of internal organ, however, the reference does not explicitly teach the internal organ is injured as claimed by claims 21, 29 and 32.
Kleidon teaches composition for potentiating stem cell therapies comprises stem cells and cannabinoid or cannabidiol encapsulated in nanoparticles for topical administration or direct delivery to the target site (abstract; ¶¶ 0006-0008, 0013, 0065). The composition can be useful for treating neurological disorder, e.g. lateral sclerosis, Alzheimer disease, Parkinsonism, and muscular dystrophy (¶¶ 0007, 0053; claims 38, 49). The composition is useful for treating brain and spinal cord injuries (¶ 0057; example 7; claim 39). The nanoparticle has size up to 500 µm, i.e. 0.5 mm (¶ 0129). The nanoparticles are formulated in a gel, liquid or solid formulation (¶ 0121).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide product comprising nanoparticles comprising cannabinoid or cannabidiol for delivery to surface of internal organ as taught by Bevier, and apply to a surface of injured spinal cord or brain as taught by Kleidon. One would have been motivated to do so because Kleidon teaches composition comprising nanoparticles comprising cannabinoid can be topically and directly applied to injured spinal cord or brain to potentiate stem cell therapies of the injured tissues. One would reasonably expect providing product or composition comprising nanoparticles comprising cannabinoid or cannabidiol that can be applied directly to injured spinal cord or brain wherein therapies of injured tissue repair is accelerated by potentiation of stem cells at the site of application.
Regarding purified cannabidiol and cannabinoid as claimed by claims 21, 29 and 32, Brevier teaches purified cannabis extract.
Regarding the intended use of the product for internal injury site as claimed by claims 21 and 29, and as claimed by the method of claim 32, this is taught by both cited references.
Regarding bio-absorbable carrier as claimed by claims 21, 29, and 32, Brevier teaches gelatin, polyglycolic acid, and polysaccharides that are used by applicants as bio-absorbable materials.
Regarding claim 22 that carrier comprises at least one of gelatin, polysaccharide, polyglycolide glycerol, cholesterol, food, seaweed, and nanoparticles, Brevier teaches gelatin, polyglycolic acid, and polysaccharides, and both Brevier and Kleidon teach nanoparticles.
Regarding claim 23 that carrier is at least one of a bandage and a foam mesh, Brevier teaches patch and foam.
Regarding claim 24 the medical carrier is dissolvable in vivo, Brevier teaches the same material of the carrier, e.g. gelatin and polyglycolide, that claimed and used by applicants and are expected to be dissolvable in vivo since materials and their properties are inseparable. Brevier further teaches microparticles dissolve in aqueous environment, i.e. body fluid environment.
Regarding claim 25 that the medical carrier is saturated with 0.1- 500 mg/ml of cannabidiol CBD, one having ordinary skill in the art would have determined the required amount of cannabidiol based on individual patient condition, e.g. sex, age, body weight, and severity of injury.
Regarding claim 26 the medical carrier is configured to a size of 0.1-500 mm, Kleidon teaches nanoparticle has size up to 500 µm, i.e. 0.5 mm that falls within the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Regarding claim 27 that medical carrier conforms to the injury site, the cited references teaches product having the same material and applied to surface of internal organ and can be in a liquid form and this implies that the product would conform to application site, e.g. injured site.
Regarding claim 28 that the injury site is at least one of the brain and spinal cord, Kleidon teaches the injury site is brain or spinal cord.
Regarding claim 30 that the carrier is at least one of gelatin foam sponge, hydrogel, and cholesterol, Brevier teaches gelatin, and foam.
Regarding claim 31 and 32 that the carrier adjusts to the surface size of the injury site, Brevier teaches substrate of polymeric material that solidify on the surface of an organ that implies the material is not solid when applied and would conform to the surface prior to solidification. In any event, one having ordinary skill in the art would have adjusted the carrier material to the size and shape of the injured tissue in order to achieve a good results without affecting the surrounding tissues.
Regarding claim 33 that the injury site follows a neurological trauma, Kleidon teaches neurological diseases treated by the claimed product that may cause neurological trauma. In any event the product taught by the combination of the cited references is capable for treating spinal cord and brain injury regardless of cause of such injury, absent evidence to the contrary
Regarding the disorders claimed by claim 34, Kleidon teaches treating the claimed disorders.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM EST.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./