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 .
Response to Applicants Instant Set of Claims
Claim 48 and was mentioned in the past rejection in the non-final dated 1/30/2026. Claim 49 will not be rejoined at this time because the technical feature that all the claim groups have in common is still taught by the prior art cited in the rejection.
Because claim 8 has been amended, the claim objection to claim 8 is removed. The amendments made to claims 18,22, and 39 have removed the indefiniteness from the claims. As a result the 112(b) rejection is withdrawn.
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, 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 1-10,14-15,18,22-23,38-40,46, and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Edwards (US 20090142303) in view of Oldinski (US 20190314555).
Edwards teaches a plurality of spray dried particles, each particle of the plurality of spray dried particles comprising a eukaryotic cell (Paragraphs 5 and 6 of Edwards), substantially encapsulated in a coating material (Paragraph 95 of Edwards), wherein:
Each particle of the plurality of spray dried particles individually has a particle diameter ranging from about 5 micrometers to about 100 micrometers, as measured by a particle analyzer using laser diffraction (Paragraphs 131 and 138 of Edwards),
The eukaryotic cells include the following cells: red blood cells, stem cells, granulocytes, fibroblasts, platelets (Paragraphs 6, 155, and 157),
about 1% to 100% of the eukaryotic cells in the plurality of the particles are alive (Paragraph 6), and
the coating material comprises a hydroxypropyl methylcellulose (HPMC), (Paragraph 95) as in instant Claim 1.
Edwards teaches the use of encapsulated therapeutic cells. Edwards does not expressly state that these cells are human cells. However, Oldinski teaches that human cells can be used for therapeutic purposes (Paragraphs 6 and 10 of Oldinski). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used human eukaryotic cells as taught by Oldinski. An artisan would have been motivated to have used human cells because they can be used for therapeutic purposes (Paragraphs 6 and 10-11 of Oldinski). Because such cells have therapeutic purposes and they can be administered nasally/orally, there would have been a high expectation for success (Paragraphs 10, 28, 104-105) as in instant Claim 1.
Dependent Claims taught by Edwards
Edwards discloses a pharmaceutically acceptable carrier (Paragraphs 134-135 of Edwards) as in instant Claim 2. Edwards teaches that the microparticles can have a diameter of about 100 nm to about 150 µm in size (Paragraph 131 of Edwards) as in instant Claim 3. Edwards teaches wherein the plurality of spray dried particles and the pharmaceutically acceptable excipient are admixed into a substantially homologous mixture (Paragraphs 133-139 of Edwards) as in instant Claim 4. Preservative excipients are present in (Claim 11 and Paragraphs 8 and 95 of Edwards) and a carbohydrate can be present (Paragraph 94 of Edwards) as in instant Claim 5. Edwards teaches that the percentage of cellular material in the composition can be greater than 0% to about 74% of the entire composition (Paragraph 15 of Edwards). MPEP § 2144.05 (II) states the following: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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 reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); 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.”); In reHoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc.v.Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In reKulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree “will not sustain a patent”); In re Williams, 36 F.2d 436, 438 (CCPA 1929) (“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”). See also KSR Int' l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying “the need for caution in granting a patent based on the combination of elements found in the prior art.”).
A review of the specification fails to provide evidence that the claimed concentration of encapsulated cells are critical. Absent such evidence, it would have been obvious to an artisan of ordinary skill at the time of effectively filing Edwards to try a finite number of possible concentrations of the encapsulated cells to predictably arrive at the claimed concentration through routine optimization. An artisan would have a reasonable expectation of success in optimizing the concentrations because determining the concentration of encapsulated cells was long established in the art as demonstrated by Edwards. Thus, Edwards renders the instantly claimed concentration of encapsulated cells in claims 6 and 7 above. Edwards discloses that red blood cells, stem cells, platelets, skin cells, blood stem cells can be encapsulated (Paragraph 8) as in instant Claim 8. Edwards teaches a listing of cells that can be used in the treatment. It would have been obvious to have used multiple cell types listed (red blood cells, stem cells, granulocytes, fibroblast, and platelets) since they all can be used in the treatment (Paragraphs 6 and 8 of Edwards). MPEP 2144.06 states the following: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine). Because all the cell types listed (red blood cells, stem cells, granulocytes, fibroblasts, and platelets) can be used in the therapy. It would have been obvious to have included multiple different eukaryotic cell types to successfully make a therapy as in instant Claim 9. Edwards teaches wherein the eukaryotic cell comprises about 1% to 99% by weight of the overall pharmaceutical composition (Paragraphs 6-7 of Edwards) as in instant Claim 10. Edwards teaches a powdery composition within a capsule (Paragraph 132 of Edwards) as in instant Claim 14. Edwards teaches wherein the plurality of spray dried particle is encapsulated by one or more additional coating materials (Paragraph 132 of Edwards) as in instant Claim 15. Edwards teaches wherein the powdery pharmaceutical composition is in a powdery pharmaceutical composition in unit dose form (Paragraphs 90-91) as in instant Claim 18. Edwards teaches wherein the powdery formulation in the form of an oral formulation (Paragraphs 5, 89,94-95 of Edwards) as in instant Claim 22. Edwards teaches wherein the plurality of spray dried particles are at least partially surrounded by a first capsule (Paragraph 132) as in instant Claim 23. Edwards teaches wherein the eukaryotic cell substantially encapsulated in the coating material has a particle diameter ranging from 100 nm to about 150 µm (Paragraph 131) as in instant Claim 38. Edwards teaches wherein the powdery formulation is in the form of an inhalable or intranasal formulation (Paragraphs 11 and 89-90) as in instant Claim 39. Edwards teaches wherein the powdery composition is contained within an inhaler unit (Paragraphs 90-91) as in instant Claim 40. Edwards teaches wherein the plurality of spray dried particles comprising the eukaryotic cell substantially encapsulated in the coating material individually has a particle diameter ranging from about 5 micrometers to about 30 micrometers (Paragraph 131 and 138 of Edwards) as in instant Claim 46. Edwards teaches a kit comprising the powdery composition contained at least in part in a packaging (Paragraphs 90-92) as in instant Claim 48.
Dependent Claims taught by Oldinski
Oldinski teaches a pharmaceutically acceptable carrier, excipient, and/or diluent (Paragraph 9 of Oldinski) as in instant Claim 2. Oldinski teaches wherein the plurality of particles and pharmaceutically acceptable excipient/carrier are admixed into a substantially homologous mixture (Paragraph 143 of Oldinski) as in instant Claim 4. Oldinski teaches that the pharmaceutically acceptable excipient comprises an alginate (Paragraphs 143-144 of Oldinski) as in instant Claim 5. Oldinski teaches that the cell can be a mesenchymal stem cell (Paragraph 6) as in instant Claim 8. Oldinski teaches wherein the powdery pharmaceutical is a powdery pharmaceutical composition in unit dose form (Paragraph 97 of Oldinski) as in instant Claim 18. Oldinski teaches wherein the powdery composition is in the form of an oral formulation (Paragraph 28 of Oldinski) as in instant Claim 23. Oldinski teaches that the powdery composition is in the form of an inhalable or intranasal formulation (Paragraph 28) as in instant Claim 39.
Edwards teaches a powdery composition that is composed of spray dried particles containing viable eukaryotic cells which are encapsulated in coating material. Edwards does not specify that the eukaryotic cells can be derived from humans. However, Oldinski teaches that therapeutic cells can be derived from humans. An artisan of ordinary skill in the art would have been motivated to have used such cells in the therapies taught by Edwards since they can successfully treat diseases/conditions. Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combinations would have yielded predicable results to one of ordinary skill in the art at the time of the invention (See KSA Internation Co.v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007)). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees including M.D.s. Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in cell culture and cell preservation methods. Therefore, the level of ordinary skill in this art is high.
Response to Applicants Arguments/Amendments
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Applicants argue that Edwards uses the HMPC as an added excipient with his described pharmaceutical powders in preparing the tablets and capsules and not to “substantially encapsulate” a eukaryotic cell. There is no language in the instant claims that the HMPC must substantially encapsulate a eukaryotic cell. The claim language recites that the coating material comprises a HPMC, HPMCAS, or a combination thereof. The instant claims do not recite that the majority or all of the coating must be composed of HPMC or that HPMC itself must fully encapsulate the eukaryotic cell. Paragraph 95 of Edwards still teaches that HPMC may be part of a coating.
Conclusion
All claims stand rejected.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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