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 .
Claim Status
Claims 5, 9-10, 12, 15-16, 18, and 21-24 are cancelled. Claims 1-4, 6-8, 11, 13, 14, 17, 19, 20, and 25-31 are pending and under examination.
Priority
This application is a national stage entry of PCT/EP2022/067349 filed on 6/24/2022, which claims priority from US provisional application 63/215,153 filed on 06/25/2021.
Information Disclosure Statements
The information disclosure statement filed on 12/24/2023 has been considered by the examiner.
Claim Objection
Claim 1 provides for PRP and BMC without having spelled them out in claim 1 for the first time to be platelet-rich plasma and bone marrow concentrate.
Claim 17 provides for PRP without spelling it out as platelet-rich plasma for the first time. Claim 17 is another independent claim.
Claim 17 recites “Hyaluronic”, which should be “hyaluronic” with lower case “h”.
Claims 28 and 31 are objected to for “mOsm” where the recitation should be written as “mOsm/l” which is supported by indicating this as osmolarity where the units are normally “mOsm/l”. Appropriate corrections are required.
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.
Claims 2-4, 6-8, 11, 25, 27, and 29 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 2, 3, 4, and 7 recite the limitation "said thixotropic gel" or “the thixotropic gel” in the claim where the prior recitation is “at least one thixotropic gel”. There is insufficient antecedent basis for this limitation in the claim. It is suggested that applicant change the recitation to “said at least one thixotropic gel” or “the at least one thixotropic gel”.
Claims 4 and 6 recites the limitation "said coagulation activator" or “the coagulation activator” in the claim where the prior recitation is “at least one coagulation activator”. There is insufficient antecedent basis for this limitation in the claim. It is suggested that applicant change the recitation to “said at least one coagulation activator”.
Claim 8 recites the limitation "the biomaterial" in the claim where the prior recitation is “at least one biomaterial”. There is insufficient antecedent basis for this limitation in the claim. It is suggested that applicant change the recitation to “the at least one biomaterial”.
Claim 11 is rejected as being dependent on an indefinite claim.
Claims 4, 6 and 29 are indefinite for the recitations of “%” without indicating what % refers to. Use of % may indicate volume %, mass%, mole% or other % measures where each would have a value with a different meaning for the claim. Applicant should indicate what % is referring to in the claim.
Claims 7, 8 and 11 are rejected for being dependent on an indefinite claim.
Claim 25 is indefinite for the term “cd-gelatin” as it is unclear what the “cd” in the term means. “cd” may refer to things like cyclodextrin or CdS (Cadmium Sulfate) quantum dots or possibly other meanings. For the purpose of compact prosecution, the examiner will read the limitation as “gelatin”.
Regarding claim 25, the phrase "such as" in the phrase “muscle cells such as myoblasts” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 25 recites the broad recitation “one or more cell extracts”, and the claim also recites “optionally or preferably an autologous cell extract, selected from an extract of keratinocytes” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In the present instance, claim 27 recites the broad recitation “drug”, and the claim also recites “/medicament” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note drug is broad to substances that affect the body while medicament is narrower for substances that have a therapeutic purpose.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4, 6-8 and 11 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. In claim 4, phenol(s) and phosphite ester are allowed to be 0% while in claim 3, on which it depends, these are both needed parts of the thixotropic gel. Thus, claim 4 is not limiting as it now makes these items optional. Claims 6-8 and 11 carry the limitation of claim 4, which is not further limiting. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, and 6 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Turzi US20230133549A1 (effective filing dates of March 30, 2021 and March 30, 2020, referred to as ‘549).
The phrase “for use in the preparation of a topical gel or topical membrane or topical patch formed from PRP or BMC-coagulation activator combination” is toward the intended use of the container that is in the preamble (see MPEP 2111.02). The claim will be read as “A container prefilled with or comprises at least one thixotropic gel and a composition comprising at least one coagulation activator.”
The applied reference has a common inventor with one additional inventor compared with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
‘549 teaches containers prefilled with thixotropic gel with density of 1.02 to 1.05 g/cm3 and anticoagulant and also teaches prefilled with thixotropic gel of the same densities and coagulation activator that is calcium gluconate (claims 1 and 18 of ‘549). Claim 18 of ‘549 provides for embodiments with layer of thixotropic gel and layer of anticoagulant as well as one with layer of thixotropic gel with layer of coagulation activator (layers from the distal end of the tube). ‘549 teaches the thixotropic gel is oligomer, polymer, polyolefin hydrocarbon oligomer, an acrylic resin mixture, a PEG-Silica Gel or any combination thereof, and in which the thixotropic gel is selected from: a polyoxyalkylene polyol, trioctyl trimellitate, a hydrocarbonated resin, silica dimethyl silylate, or any combination thereof (claim 8 of ‘549). ‘549 also provides for thixotropic gel densities of 1.04 to 1.045 g/cm3 (claim 7 of ‘549). ‘549 teaches thixotropic gel of “thixotropic gel comprises trioctyl trimellitate in the range of 40-60%, silica in the range of 2-10%, hydrocarbon resin in the range of 30-60%, polyol in the range of 1-5%, phenol(s) in the range of 0-1%, and phosphite ester in the range of 0% to 0.06%.” (claims 57 and 60 and paragraphs 202-210 of ‘549). ‘549 teaches “calcium gluconate at about 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10% to about 20% may be added in the container (tube) as second layer above the thixotropic gel layer. More preferably, calcium gluconate at about 10% is used.” (paragraph 25). ‘549 teaches “In some embodiments, the trioctyl trimellitate is Tris (2 ethylhexyl), said silica is Dimethyl dichlorosilane, said hydrocarbon resin is Cycloaliphatic hydrocarbon Resin, said polyol is Polyalkylene Polyol, said phenol(s) is Tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate of pentaerythritol) and said phosphite ester is Phosphite of tris (2,4-di-tert-butylphenyle) (paragraphs 202-204). ‘549 teaches PRP or BMC for use in the devices (paragraphs 114, 117 and 166).
Claims 1 and 13 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Turzi US 20170087228A1.
The phrase “for use in the preparation of a topical gel or topical membrane or topical patch formed from PRP or BMC-coagulation activator combination” is toward the intended use of the container that is in the preamble (see MPEP 2111.02). The claim will be read as “A container prefilled with or comprises at least one thixotropic gel and a composition comprising at least one coagulation activator.”
Turzi teaches “new processes, tubes and devices for thrombin, platelet concentrate and wound healant preparations, alone or in combination with cell extracts, cell compositions and uses thereof.” (abstract). Turzi teaches “a tube suitable for centrifugation; a thixotropic gel disposed in the tube, the thixotropic gel adapted for separating thrombin serum; and a coagulation activator disposed in the tube” (claim 6 of Turzi). Turzi teaches coagulation activators including calcium chloride, calcium gluconate and thrombin (paragraphs 221-222). Figure 16 provides for a closed tube with hyaluronic acid at the bottom, cell selector gel above that and sodium citrate (the anticoagulant) above the cell selector gel (figure 16 and paragraph 169 which states thixotropic gel as the cell selector gel). The tubes are centrifuged after whole blood is added (figure 16 and paragraph 169). As stated above, Turzi teaches a tube with hyaluronic acid (biomaterial), thixotropic gel and anticoagulant while also indicating that coagulation activators would be present in the tube. Turzi does teach that wound healant or tissue healant composition may be combined with hyaluronic acid (paragraph 106). Turzi teaches “In another aspect, the present invention provides a wound healant or tissue healant composition comprising: a) a thrombin serum according to the invention, b) a platelet-rich plasma or plasma concentrate preferably according to the invention, and c) TCP, chitosan, hyaluronic acid, cream, cream mask, fat cells, fat tissue, bone marrow concentrate, lubricin, cd-gelatin, botulinum toxin and/or stem cells (paragraphs 126-129). This allows an option for hyaluronan and thrombin to be in a composition. Turzi teaches new PRP formulations (paragraph 13). Turzi teaches bone marrow concentrate (paragraphs 92 and 122 and 653).
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.
Claim 14 in addition to claims 1 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Turzi US 20170087228A1.
Turzi teaches the claims as discussed above.
Turzi does not particularly teach an embodiment with the biomaterial and coagulation activator forming a single layer or single composition.
Turzi teaches “In another aspect, the present invention provides a wound healant or tissue healant composition comprising: a) a thrombin serum according to the invention, b) a platelet-rich plasma or plasma concentrate preferably according to the invention, and c) TCP, chitosan, hyaluronic acid, cream, cream mask, fat cells, fat tissue, bone marrow concentrate, lubricin, cd-gelatin, botulinum toxin and/or stem cells (paragraphs 126-129). This allows an option for hyaluronan and thrombin to be in a composition. It is also noted above that Turzi does teach biomaterials such as hyaluronic acid as well as coagulation factors for its product. It is noted above that Turzi does provide a layer of hyaluronic acid in its tube.
One of ordinary skill in the art before the time of filing would have included a biomaterial like hyaluronic acid and coagulation factor together as a single layer or single composition as Turzi’s teachings allow for these agents to be combined in forming products for wound and tissue healing. Thus, providing an amount of coagulation activator in the hyaluronic layer/composition will be expected to increase the healing efficacy of the formed product. Therefore, there was a reasonable expectation of success in modifying Turzi’s tube product with hyaluronic acid biomaterial layer and including coagulation activator within the composition of the single layer to produce products with better healing ability.
Claims 2, 17, 19, 20, 25-27, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Turzi US 20170087228A1 and Zine US4021340A.
In claim 17, the phrase “for use in the preparation of a topical gel or topical membrane or topical patch formed from a hyaluronic acid, and a PRP and/or bone marrow concentrate (BMC)-coagulation activator combination” is toward the intended use of the container that is in the preamble (see MPEP 2111.02). The claim will be read as “A container in which the container is prefilled with or comprises:……”
Applicant provides for “proximal end” and “distal end” with “proximal end” having an aperture for the collection of material (paragraph 24). Aperture is an opening, and thus, the distal end is the other/opposite end of the tube/container.
In regards to claims 26-27, these are to the use of the container product since they are to what the container “creates”. Such isolated plasma derived product or bone marrow derived products would be able to be produced by similar containers with similar components of the prior art. These are product claims and not method of using claims.
Turzi teaches the claims as discussed above. Turzi teaches “the preparation of a wound or tissue healant composition wherein the coagulation activator which is admixed is calcium gluconate or 10% calcium chloride” (paragraphs 426-427). Turzi teaches the blood collection tubes may be evacuated and/or sealed (paragraphs 543 and 560). Sealed is closed to the atmosphere. Turzi teaches thixotropic gel formed from polymer (paragraphs 115-117). Turzi teaches calcium gluconate as coagulation activator (paragraph 222). Turzi teaches extract as well as various cells like fat cells and fibroblasts (paragraph 254). Turzi also teaches “a cell extract, cell composition, TCP, chitosan, hyaluronic acid, cream, cream mask, fat cells, fat tissue, bone marrow concentrate, lubricin, cd-gelatin, botulinum toxin and/or stem cells” (paragraph 92, albumin in paragraph 458). Turzi teaches the container with elements as discussed above in rejections under USC 102 and USC 103 over Turzi.
Turzi does not teach the density of the thixotropic gel.
Zine teaches gel-like compositions useful for separating and partitioning whole blood with the composition having a specific gravity of 1.030 to 1.090 (abstract and summary of the invention). Zine teaches 1.037 to 1.050 in the specific embodiments and claim 2 of Zine. Zine recognizes the composition as thixotropic (claim 7 of Zine).
One of ordinary skill in the art before the time of filing would have utilized the specific gravity thixotropic compositions of Zine as the thixotropic gels of Turzi as these compositions are seen as useful for forming a barrier between the serum and clot portions of centrifuged blood material (see abstract of Zine). As the specific gravity multiplied by 1 g/cm3 would offer the density, the density of Zine’s compositions are 1.037 g/cm3 to 1.050 g/cm3 or 1.030 g/cm3 to 1.090 g/cm3. Therefore, there was a reasonable expectation of success of using thixotropic gels with the densities of Zine to produce a working container of Turzi where its thixotropic gel would allow separation of serum from clot portions.
Claims 28 and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Turzi US 20170087228A1, Zine US4021340A and Foghsgaard WO2008009642A1.
Turzi and Zine teach the claims as provided above. It is noted that Turzi recognizes the plasma of the invention as a suitable cell culture medium (paragraph 256 of Turzi). Turzi also teaches “The advantage of the process for the preparation of a cell composition according to the invention is that the same autologous medium is used as vector for cell culture, cell preservation, cell injection, vector for cell bio-stimulation and tissue regeneration.” (paragraph 599).
Turzi and Zine does not teach the pH and osmolarity.
Foghsgaard teaches media for cell culturing (abstract and pages 12-13). Foghsgaard teaches advantageous osmolarity of 150-450 mOsm and buffering for a pH of 6-8 or 6.5-7.5 (page 13).
One of ordinary skill in the art before the time of filing would have produced the product motivated by Turzi and Zine with considerations of cell culturing as its product takes culturing of cells into consideration. Therefore, one of ordinary skill in the art would consider optimal pH and osmolarity values for culturing cells that are taught as optimal in Foghsgaard for the products of Turzi. Thus, there was a reasonable expectation of success in combining the teachings of the prior art to obtain a product that would allow for pH and osmolarity values of the isolated materials it creates.
Claims 2-4, 6-8, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Turzi US 20170087228A1 and Turzi US20230133549A1 (effective filing dates of March 30, 2021 and March 30, 2020, referred to as ‘549).
Turzi teaches the claims as discussed above.
Turzi does not teach the density of the thixotropic gel or the composition of the thixotropic gel as in claims 3 and 4.
‘549 teaches containers prefilled with thixotropic gel with density of 1.02 to 1.05 g/cm3 and anticoagulant and also teaches prefilled with thixotropic gel of the same densities and coagulation activator that is calcium gluconate (claims 1 and 18 of ‘549). Claim 18 of ‘549 provides for embodiments with layer of thixotropic gel and layer of anticoagulant as well as one with layer of thixotropic gel with layer of coagulation activator (layers from the distal end of the tube). ‘549 teaches the thixotropic gel is oligomer, polymer, polyolefin hydrocarbon oligomer, an acrylic resin mixture, a PEG-Silica Gel or any combination thereof, and in which the thixotropic gel is selected from: a polyoxyalkylene polyol, trioctyl trimellitate, a hydrocarbonated resin, silica dimethyl silylate, or any combination thereof (claim 8 of ‘549). ‘549 also provides for thixotropic gel densities of 1.04 to 1.045 g/cm3 (claim 7 of ‘549). ‘549 teaches thixotropic gel of “thixotropic gel comprises trioctyl trimellitate in the range of 40-60%, silica in the range of 2-10%, hydrocarbon resin in the range of 30-60%, polyol in the range of 1-5%, phenol(s) in the range of 0-1%, and phosphite ester in the range of 0% to 0.06%.” (claims 57 and 60 and paragraphs 202-210 of ‘549). ‘549 teaches “calcium gluconate at about 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10% to about 20% may be added in the container (tube) as second layer above the thixotropic gel layer. More preferably, calcium gluconate at about 10% is used.” (paragraph 25). ‘549 teaches “In some embodiments, the trioctyl trimellitate is Tris (2 ethylhexyl), said silica is Dimethyl dichlorosilane, said hydrocarbon resin is Cycloaliphatic hydrocarbon Resin, said polyol is Polyalkylene Polyol, said phenol(s) is Tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate of pentaerythritol) and said phosphite ester is Phosphite of tris (2,4-di-tert-butylphenyle) (paragraphs 202-204). ‘549 teaches PRP or BMC for use in the devices (paragraphs 114, 117 and 166).
One of ordinary skill in the art before the time of filing would have combined the teachings of Turzi and ‘549 to utilize the thixotropic gel with density taught by ‘549 into the tube product of Turzi as its thixotropic gel as they are both thixotropic gels used along with coagulation activators and/or anticoagulants for blood/cell preparations. There would be a reasonable expectation of success in using the thixotropic gel of ‘549 as a thixotropic gel in the product of Turzi and obtaining a useful container for preparing wound healing compositions using blood materials.
Zine teaches gel-like compositions useful for separating and partitioning whole blood with the composition having a specific gravity of 1.030 to 1.090 (abstract and summary of the invention). Zine teaches 1.037 to 1.050 in the specific embodiments and claim 2 of Zine. Zine recognizes the composition as thixotropic (claim 7 of Zine).
One of ordinary skill in the art before the time of filing would have utilized the specific gravity thixotropic compositions of Zine as the thixotropic gels of Turzi as these compositions are seen as useful for forming a barrier between the serum and clot portions of centrifuged blood material (see abstract of Zine). As the specific gravity multiplied by 1 g/cm3 would offer the density, the density of Zine’s compositions are 1.037 g/cm3 to 1.050 g/cm3 or 1.030 g/cm3 to 1.090 g/cm3. Therefore, there was a reasonable expectation of success of using thixotropic gels with the densities of Zine to produce a working container of Turzi where its thixotropic gel would allow separation of serum from clot portions. There is no indication in the references that PBS has to be in the hyaluronic acid and coagulation activator.
Non-Statutory 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 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 7, 8, 57, and 60 of copending Application No. 17/916,507 (reference application). ‘507 provides for option (iii) of claim 1 with thixotropic gel having a density of 1.02 to 1.05g/cm3 and coagulation activator that comprises calcium gluconate. ‘507 teaches a composition of thixotropic gel like that of applicant’s claims. ‘507 provides for a container.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 13 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 3, 4, 8, 10, 11, 12, 15 and 31 of copending Application No. 17/353,787 (reference application) and claim 2 in view of Zine US4021340A. ‘787 teaches a container with composition with hyaluronic acid and the coagulation activator and also adds anticoagulant and thixotropic gel.
Zine teaches gel-like compositions useful for separating and partitioning whole blood with the composition having a specific gravity of 1.030 to 1.090 (abstract and summary of the invention). Zine teaches 1.037 to 1.050 in the specific embodiments and claim 2 of Zine. Zine recognizes the composition as thixotropic (claim 7 of Zine).
In regards to claim 2, one of ordinary skill in the art before the time of filing would have utilized the specific gravity thixotropic compositions of Zine as the thixotropic gels of ‘787 as these compositions are seen as useful for forming a barrier between the serum and clot portions of centrifuged blood material (see abstract of Zine). As the specific gravity multiplied by 1 g/cm3 would offer the density, the density of Zine’s compositions are 1.037 g/cm3 to 1.050 g/cm3 or 1.030 g/cm3 to 1.090 g/cm3. Therefore, there was a reasonable expectation of success of using thixotropic gels with the densities of Zine to produce a working container of ‘787 where its thixotropic gel would allow separation of serum from clot portions.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-6 of U.S. Patent No. 8945537B2 and claim 2 in further view of Zine US4021340A. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘537 also provides a container/tube that has thixotropic gel, coagulation activator (thrombin serum) and anticoagulant (sodium citrate) along with hyaluronic acid (biomaterial) in the container.
‘537 does not provide the density of the thixotropic gel, however, a thixotropic gel would have a density.
Zine teaches gel-like compositions useful for separating and partitioning whole blood with the composition having a specific gravity of 1.030 to 1.090 (abstract and summary of the invention). Zine teaches 1.037 to 1.050 in the specific embodiments and claim 2 of Zine. Zine recognizes the composition as thixotropic (claim 7 of Zine).
In regards to claim 2, one of ordinary skill in the art before the time of filing would have utilized the specific gravity thixotropic compositions of Zine as the thixotropic gels of ‘537 as these compositions are seen as useful for forming a barrier between the serum and clot portions of centrifuged blood material (see abstract of Zine). As the specific gravity multiplied by 1 g/cm3 would offer the density, the density of Zine’s compositions are 1.037 g/cm3 to 1.050 g/cm3 or 1.030 g/cm3 to 1.090 g/cm3. Therefore, there was a reasonable expectation of success of using thixotropic gels with the densities of Zine to produce a working container of ‘537 where its thixotropic gel would allow separation of serum from clot portions.
Claims 1 and 13-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 13-14, 18 and 21 of U.S. Patent No. 9517255B2 and claims 2, 17, 19, 20, 25, 26, 27, and 29 in further view of Zine US4021340A and claims 28 and 30-31 in further view of Zine and Foghsgaard WO2008009642A1. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘255 also provides a container/tube that has thixotropic gel made of polymer mixture, coagulation activator, and anticoagulant along with hyaluronic acid (biomaterial) and calcium gluconate in the container/composition. ‘255 allows for the layering of the anticoagulant, thixotropic gel and hyaluronic acid in the tube while also allowing for mixing of hyaluronic acid and thrombin serum or calcium gluconate. ‘255 provides for the container being sealed and for centrifugation.
‘255 does not provide the density of the thixotropic gel, however, a thixotropic gel would have a density.
Zine teaches gel-like compositions useful for separating and partitioning whole blood with the composition having a specific gravity of 1.030 to 1.090 (abstract and summary of the invention). Zine teaches 1.037 to 1.050 in the specific embodiments and claim 2 of Zine. Zine recognizes the composition as thixotropic (claim 7 of Zine).
In regards to claim 2, one of ordinary skill in the art before the time of filing would have utilized the specific gravity thixotropic compositions of Zine as the thixotropic gels of ‘255 as these compositions are seen as useful for forming a barrier between the serum and clot portions of centrifuged blood material (see abstract of Zine). As the specific gravity multiplied by 1 g/cm3 would offer the density, the density of Zine’s compositions are 1.037 g/cm3 to 1.050 g/cm3 or 1.030 g/cm3 to 1.090 g/cm3. Therefore, there was a reasonable expectation of success of using thixotropic gels with the densities of Zine to produce a working container of ‘255 where its thixotropic gel would allow separation of serum from clot portions.
Foghsgaard teaches media for cell culturing (abstract and pages 12-13). Foghsgaard teaches advantageous osmolarity of 150-450 mOsm and buffering for a pH of 6-8 or 6.5-7.5 (page 13).
One of ordinary skill in the art before the time of filing would have produced the product motivated by ‘255 and Zine with considerations of cell culturing as its product takes culturing of cells into consideration. Therefore, one of ordinary skill in the art would consider optimal pH and osmolarity values for culturing cells that are taught as optimal in Foghsgaard for the products of ‘255. Thus, there was a reasonable expectation of success in combining the teachings of the prior art to obtain a product that would allow for pH and osmolarity values of the isolated materials it creates.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10 and 15 of U.S. Patent No. 10226516B2 and claim 2 in further view of Zine US4021340A. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘516 also provides a container/tube that has thixotropic gel, coagulation activator (thrombin serum) and anticoagulant (sodium citrate) along with hyaluronic acid (biomaterial) in the container.
‘516 does not provide the density of the thixotropic gel, however, a thixotropic gel would have a density.
Zine teaches gel-like compositions useful for separating and partitioning whole blood with the composition having a specific gravity of 1.030 to 1.090 (abstract and summary of the invention). Zine teaches 1.037 to 1.050 in the specific embodiments and claim 2 of Zine. Zine recognizes the composition as thixotropic (claim 7 of Zine).
In regards to claim 2, one of ordinary skill in the art before the time of filing would have utilized the specific gravity thixotropic compositions of Zine as the thixotropic gels of ‘516 as these compositions are seen as useful for forming a barrier between the serum and clot portions of centrifuged blood material (see abstract of Zine). As the specific gravity multiplied by 1 g/cm3 would offer the density, the density of Zine’s compositions are 1.037 g/cm3 to 1.050 g/cm3 or 1.030 g/cm3 to 1.090 g/cm3. Therefore, there was a reasonable expectation of success of using thixotropic gels with the densities of Zine to produce a working container of ‘516 where its thixotropic gel would allow separation of serum from clot portions.
Conclusion
No claims are allowed.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613