Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-17, drawn to a placental composition composed of placental cells and disrupted chorionic membrane pieces, classified in A61K 35/50.
II. Claims 18-21, drawn to a method of treating a tissue injury comprising administering the placental composition of Invention I, classified in A61L 27/3604.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the inventive groups are distinct because Invention I can be used as a postpartum nutritive powder and does not have to be used for treating a tissue injury.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
Invention I can be used for other purposes besides the method described in Invention II. For example, Invention I can be a form of encapsulated placenta nutrition that some women take after giving birth. Searching all inventions would be an undue burden on examiner, especially since each invention can be classified differently in the CPC scheme.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Sarah Eddy on April 23, 2026 a provisional election was made without traverse to prosecute the invention of Invention I, claims 1-17. Affirmation of this election must be made by applicant in replying to this Office action. Claims 18-21 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: refrigeration in a cryopreservation medium at a temperature of 2-8°C needs to be disclosed in the specification. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 1-3,12-15, 17 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Liu (US 20080181967)
Liu teaches a suspension that is composed of disrupted and minced chorion (Paragraphs 19,21, 27-28, and 30 of Liu). Paragraph 25 of Liu states, “that the placenta tissue used to make the composition of the invention, e.g. suspension, solution, slurry, gel, or paste retains the tissue’s native cells.” The suspension that is homogenized would be composed of pieces and cells of the chorionic membrane (Paragraphs 19,21,27, and 30). The material of Lee is not required to undergo a culture period. Paragraphs 15 and 69 of Liu further state that Liu’s suspension can be created/disrupted in the presence of refrigeration temperatures (Paragraph 57 of Liu). The entire chorion membrane is disrupted so it would include stromal cells, fibroblast, placental stem cells, mesenchymal stem cells, epithelial cells, and progenitor cells. The disrupted parts of the chorion membrane would be able to release placental factors. The dispersion of Liu is composed of cells and pieces of chorion and is exposed to the same conditions as applicants invention so it would be expected to also have a decreased number of CD14+ macrophage cells present as in instant Claim 1. Paragraphs 9 and 77 of Liu further state that its composition can be lyophilized (freeze dried) which would involve exposing the composition to freezing temperatures (Paragraph 77 of Liu) as in instant Claim 2-3. In paragraph 63 of Liu, Liu teaches that material greater than 500 microns is removed, this would still allow for tissue components between 100 to less than 500 microns in length to be present as in instant Claim 12. The entire chorionic membrane can be disrupted to form the solution/dispersion of cells/tissue. Because the entire chorionic membrane is disrupted (Paragraphs 27 and 30 of Liu), the following cells would be expected to be present: placental progenitor cells, placental mesenchymal cells, fibroblasts, epithelial cells, or a combination as in instant Claim 13. Liu teaches where the product is comprised in a dermatologically acceptable pharmaceutical formulation (Paragraph 61 of Liu) as in instant Claim 14. Because Liu teaches the same composition as claimed by applicant, Liu’s chorion composition would be expected to have one or more extracellular matrix proteins, one or more protease inhibitors, or more growth factors, one or more angiogenic factors, and one or more MMPs present (Paragraphs 15,27,30, and 77 of Liu) as in instant Claim 15. Liu teaches wherein the first fraction of placental cells and the disrupted chorionic membrane have not been frozen or lyophilized (freezing and lyophilization is optional—Paragraphs 9 and 77 of Liu) as in instant Claim 17.
The reference anticipates the claim limitations.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-3,12-17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Liu (US 20080181967)
Claims 1-3,12-15,17 apply as above as taught by Liu. Liu does not expressly state that several of its inventive dispersion compositions can be combined together to develop a therapeutic product. Liu teaches that its dispersion composition can be administered in a solution, gel, or paste (Paragraph 11 of Liu). Liu also teaches that its composition can be lyophilized (Paragraph 9 of Liu). Both forms of treatment can be used for the repair and treatment of various body tissues, such as skin, organs, and the like (Paragraph 3 of Liu). MPEP 2144.06 states, “"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). In this case, it would have been obvious to have combined Liu’s different cell/dispersion formulations since they both can accomplish the same treatment goals as in instant Claim 16.
An artisan would have been motivated to have combined one of Liu’s fresh cell/dispersion composition with Liu’s cell/dispersion lyophilized formulation since both compositions are composed of the same chorion membrane matter and each one can be used to treat and repair tissue and organs. 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 of 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 combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSR International 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 and 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 biology, graft therapy, and placental culture. Therefore, the level of ordinary skill in this art is high.
Claims 1-3,5-6,8-10,13, and 15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Strom US 20030235563 in view of Allickson (US20080064098)
Strom teaches chorionic membrane can be broken up into smaller pieces such as individual cells (Paragraphs 16, 27,47,59; Section 5.6; Paragraph 98 of Strom). The chorionic placental cells of Strom can be isolated and cryopreserved at -80°C during a freezing process that also involves refrigeration temperatures which would inherently destroy CD14+ cells (Section 5.6; Paragraph 98 of Strom). Some of Strom’s chorionic cells can represent fractions of chorion cells from distinct portions of chorionic membrane while the other portion of Strom’s chorionic cells can represent a disrupted chorionic membrane (also in the form of cells) derived from another portion of the chorionic membrane. The isolated chorionic cell population of Strom can be interpreted as being cells and disrupted chorionic membrane material which is composed of chorion cells (Paragraphs 16 and Section 5.6, Paragraph 98 of Strom). Because the fractions placental chorionic cells and disrupted chorionic membrane can all be chorionic cells, the instant claim is not distinguishable from the chorionic cells taught by Strom wherein each cell is from a distinct portion of chorionic membrane (Paragraphs 16 and Section 5.6, Paragraph 98 of Strom) as in instant Claim 1.
Strom fails to teach that the cells are not exposed to an ex-vivo culture/expansion process. Paragraph 22 of Allickson teaches isolating a population of placental stem cells and then subsequently freezing them without first involving a culture step (Paragraph 22 and 24 of Allickson). Paragraph 40 of Allickson states that after isolation, the placental cells can be cryopreserved or cultured; therefore, the placental cells do not necessarily have to be cultured first. An artisan would have been motivated to have used such a method involving direct cryopreservation because it allows for easy isolation of placental cells and rapid freezing to help ensure the viability of such cells (Paragraph 24 of Allickson) as in instant Claim 1.
Dependent Claims taught by Strom
Strom discloses wherein the placental product was previously refrigerated (Paragraph 98 of Strom mentions that the temperature is slowly reduced to -80°C (rate of temperature reduction of 1°C/min) which would inherently mean that the temperature slowly goes from a culturing temperature to refrigeration temperatures before eventually hitting -80°C) as in instant Claim 2. Strom discloses wherein the placental product was previously refrigerated in a cryopreservation medium (Paragraph 98 of Strom) as in instant Claim 3. Strom discloses wherein the placental product is cryopreserved (Paragraph 98 of Strom) as in instant Claim 5. Strom discloses wherein the placental product was previously refrigerated and cryopreserved (Paragraph 98 of Strom) as in instant Claim 6. Strom discloses wherein the first fraction of placental cells comprises at least 70% viable cells (Paragraph 98 of Strom) as in instant Claims 8-9, Strom discloses wherein cell viability is determined after cryopreserving and thawing the placental product (Paragraph 98 of Strom) as in instant Claim 10. The cells are derived from an entire chorion so they would be composed of mesenchymal cells, fibroblast, epithelial cells, and progenitor cells since these cells make up part of the chorion membrane (Paragraph 98 of Strom) as in instant Claim 13. Strom teaches the same method of cryopreservation taught by applicant so it would be expected that the cells would have one for more placental factors that comprise one or more extracellular matrix proteins, one or more protease inhibitors, one or more growth factors, one or more angiogenic factors, and one or more MMPs (Paragraph 98 of Strom) as in instant Claim 15.
Strom teaches a composition of chorionic placental cells (fractions of placental cells isolated from a portions of the chorionic membrane/disrupted chorionic membrane). Strom teaches that these cells can be cultured/expanded ex vivo. However, Allickson teaches that such cells can be harvested and then immediately frozen without an expansion step. An artisan would have been motivated to have not expanded the cells because immediate freezing after harvesting helps to maintain the cell viability. 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 of 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 combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSR International 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 and 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 biology, graft therapy, and placental culture. Therefore, the level of ordinary skill in this art is high.
Claims 1-3,5-6,8-11,13,15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Strom US 20030235563 in view of Allickson (US20080064098) and Parolini (WO 2008151846)
Strom and Allickson apply as above to teach claims1-3,5-6,8-10,13, and 15. Strom teaches the manufacture of pieces and cells of chorion. Strom does not teach the importance of removing the trophoblast first. However, Parolini teaches that the trophoblast layer can be removed form chorionic material (Page 5). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have removed the trophoblast layer. An artisan would have been motivate to have removed the trophoblast cell as taught in Parolini because trophoblast cells are known to trigger unwanted immune responses and Parolini teaches that removing the trophoblast layer is desirable (Page 5 of Parolini). There would have been a high expectation for success, because Parolini teaches that trophoblast cells can be successfully removed (Page 5) when creating a useful placental cell therapy as in instant Claim 11.
Strom does expressly mention the inclusion of chorionic stromal cells in the placental cell composition. However, Parolini does teach about the advantages of stromal cells from a chorionic membrane (Abstract; Page 5). The placental composition of Strom can be used for therapeutic purposes to repair wounds and treat diseased tissue via cell transplantation therapy or tissue engineering (Paragraph 48 of Strom). An artisan would have been motivated to have included the stromal cells of the Parolini reference because the stromal cell populations isolated from chorionic tissue is belied to improve immune tolerance of transplanted materials (Page 3 ; bottom of page). Because stromal cells have advantageous properties, like promotion of immune tolerance, there would have been a high expectation for success (Abstract, Page 5). as in instant Claim 13.
Strom teaches a composition of chorionic placental cells (fractions of placental cells isolated from a portions of the chorionic membrane/disrupted chorionic membrane). Strom teaches that these cells can be cultured/expanded ex vivo. However, Allickson teaches that such cells can be harvested and then immediately frozen without an expansion step. An artisan would have been motivated to have not expanded the cells because immediate freezing after harvesting helps to maintain the cell viability. An artisan would have been further motivated to have used the teachings of Parolini since Parolini teaches the removal of the trophoblast layer/cells from the placental material which prevents undesirable immune responses. Furthermore, Parolini teaches that stromal cells in a placental population can provide positive immune benefits. Therefore, an artisan would have been motivated to have included stromal cells. 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 of 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 combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSR International 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 and 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 biology, graft therapy, and placental culture. Therefore, the level of ordinary skill in this art is high.
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 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,986,498. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Patent 11,986,498 are actually a species of the instant set of claims. The claims of Application 11,986,498 recite two fractions of placental cells, pieces of chorionic membrane that are greater than 100 µm in length, and wherein the placental product is refrigerated in a cryopreservation medium at a temperature of 2-8°C for about 30 to 60 minutes. Each set of claims has the same components with viable cells that would be able to express the same factors, proteins, and MMPs. Therefore, claim 1 of Patent 11,986,498 discloses the limitations of instant claims 1 and 15. Instant claim 2 corresponds to claim 1 of Patent 11,986,498. Instant claim 3 corresponds to claim 1 of Patent 11,986,498. Instant claim 4 corresponds to claim 1 of Patent 11,986,498. Instant claims 5-6 correspond to claim 1. Instant claim 7 corresponds to claim 1 of Patent 11,986,498. Instant claims 8-10 correspond to claim 2 of Patent 11,986,498. Instant claim 11 corresponds claim 3 of Patent 11,986,498. Instant claim 12 corresponds to claim 1 of Patent 11,986,498. Instant claim 13 recites that the placental product contains mesenchymal stem cells, fibroblasts, and epithelial cells. These cells are inherently present in chorionic membrane and would be present in isolated cells produced from the chorion membrane. Therefore, the placental cells isolated from chorionic membrane recited in claim 1 of Patent 11,986,498 would also possess mesenchymal stem cells, fibroblasts, progenitor, and epithelial cells. Therefore, instant claim 13 corresponds to claim 1 of Patent 11,986,498. Instant claim 14 corresponds to claim 4 of Patent 11,986,498. Claim 1 of Patent 11,986,498 results in a composition that inherently produces the factors recited in instant claim 15.
Claims 1,3,5,8-11,15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,8-11 of U.S. Patent No. 9,956,248. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a composition comprising chorionic cells and pieces of chorionic membrane. Instant claim 1 corresponds to claim 1 of Patent 9,956,248. Instant claim 3 corresponds to claims 1 and 9-11 of Patent 9,956,248. Instant claim 5 corresponds to claims 1,9-11 of Patent 9,956,248. Instant claims 8-9 correspond to claim 11 of Patent 9,956,248. Instant claim 10 corresponds to claims 9-11 of Patent 9,956,248. Instant claim 11 corresponds to claim 8 of Patent 9,956,248. Because the instant claims recite the same composition, it would be expected that the compositions would secrete/produce the same factors. Therefore, claim 15 corresponds to claim 1 of Patent 9,956,248.
Claims 1,5,11,13, and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,7,10, and 15 of U.S. Patent No. 10,646,519. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite chorionic cells and a chorionic membrane dispersion; each of the compositions in the claims are known to release factors since they are composed of live cells. Therefore, instant claim 1 corresponds to claim 1 of Patent 10,646,519. Instant claim 5 corresponds to claim 15 of Patent 10,646,519. Instant claim 11 corresponds to claim 7 of Patent 10,646,519. Claim 13 recites that the placental cells are composed of placental progenitor cells, placental mesenchymal cells, fibroblasts, epithelial cells, or a combination thereof. Claim 13 corresponds to independent claim 1 of Patent 10,646,519 because these cells are inherently present in chorionic material which is the source of the cell populations and dispersion recited in claim 1 of Patent 10,646,519. Instant claim 15 corresponds to claim 10 of Patent 10,646,519.
Claims 1,11,13,15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,7,11 of U.S. Patent No. 11,590,173. Although the claims at issue are not identical, they are not patentably distinct from each other because both set of claims disclose compositions that include individual cells and pieces derived from the chorionic membrane. Instant claim 1 corresponds to claim 1 of Patent 11,590,173. Instant claim 11 corresponds to claim 1 of Patent 11,590,173. Instant claim 13 corresponds to claim 7 of Patent 11,590,173. Instant claim 15 corresponds to claim 11 of Patent 11,590,173.
Conclusion
All claims stand rejected.
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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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
Prosecution Insights