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 .
DETAILED ACTION
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 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.
Election/Restrictions
Applicant’s election with traverse of Group I, claims 1, 12-21 and 24-27, in the reply filed on Aug. 15, 2026 is acknowledged. Claims 22, 23, and 28-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention.
The traversal is on the grounds that the groups of inventions share the special technical feature.
Specifically, Applicant argues that the specific process feature constitutes a special technical feature distinguishing the invention not the broad concept of cell source and extract as cited by the Examiner (Remarks pg. 11 para. 4). Applicant argues that Chu only mentions that adipose-derived stem cell extract contains proteins, but does not teach the specific nuclease enzymatic hydrolysis step and chromatographic purification conditions claimed and therefore does not teach the preparing a neural repair protein composition with a specific molecular weight and composition through a specific process (Remarks pg. 11-12 bridging para.). Applicant argues that the specific enzymatic hydrolysis and chromatographic purification steps produces a composition that has a molecular weight range of 20 to 250 kDa (Remarks 12 pg. para. 2). Applicant argues that Example 2 and 3 demonstrate that this specific composition has significant effects in repairing ischemic stroke injury (Remarks 12 pg. para. 2). Applicant argues that the ordinary mesenchymal stem cell extract such as Chu’s have not undergone the specific chromatographic purification to enrich functional proteins within a particular range and further contains large-molecule nucleic acids or other impurities that could cause immune reactions or adverse effects unlike the claimed composition has a high purity, high activity and low immunogenicity. Applicant argues that the specific enzymatic hydrolysis-chromatographic purification process feature and resulting product characteristics is a special technical feature shared by the claimed groups of inventions and not disclosed in Chu (Remarks pg. 12-13 bridging para.). Applicant argues that the category of the present invention is “a produce, a process specially adapted for the manufacture of the said product, and a use of the said product” and groups I-V have the same special technical features and form a single general inventive concept under PCT Rule 13.1 (Remarks pg. 13 para. 2).
These arguments were not found persuasive because as indicated by the rejections below, the groups do not share the special technical feature which contributes over the prior art at the time the invention was made.
In addition, as stated in the MPEP 716.01(c) I, “Objective evidence which must be factually supported by an appropriate affidavit or declaration to be of probative value includes evidence of unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the applicant.” Attorney statements or arguments cannot take the place of evidence which must be supported by an appropriate affidavit or declaration. MPEP 716.01(c) II
With respect to the argument Groups I-V fit the category of “a produce, a process specially adapted for the manufacture of the said product, and a use of the said product” The PCT rules provide for the examination of the first claimed product, the first claimed method of making that product, and the first claimed method of using that product in one application, but do not provide for the examination of multiple products or unrelated methods.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1, 12-21 and 24-27 are presented for examination on the merits.
Status of the Claims
Claims 1 and 12-30 are currently pending.
Claims 28-30 are amended.
Claims 22, 23, and 28-30 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 1-11 are cancelled.
Claims 1, 12-21 and 24-27 have been considered on the merits.
Specification
The disclosure is objected to because of the following informalities: the use of trademarks.
The use of the terms: WondaGuard™ C18 on pg. 20 para. 1, and pg. 21 para. 2; Shimsen® Ankylo on pg. 20 para. 1, pg. 21 para. 2, and pg. 22 last para., which are a trade names or a marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Objections
The disclosure is objected to because of the following informalities:
Claims 1 and 18 are objected to in the recitation of “the mesenchymal passage cells are derived from an umbilical cord” in the last line, and in the interest of improving claim form, it is suggested that the recited phrase be amended to recite “wherein the mesenchymal passage cells are derived from an umbilical cord”.
Claim 24 is objected to in the recitation of “wherein neural composition the is composed of” in lines 1-2 and the recitation of “of any one of claims 1” in line 2, and in the interest of improving claim form, it is suggested that the recited phrases be amended to recite “wherein the neural composition claim 1”.
Claim 25 is objected to in the recitation of “wherein neural composition the is composed of” in lines 1-2 and the recitation of “of any one of claims 18” in line 2, and in the interest of improving claim form, it is suggested that the recited phrases be amended to recite “wherein the neural composition claim 18”.
Claim 26 is objected to in the recitation of “injection paste” in line 2, and in the interest of improving claim form, it is suggested that the recited phrases be amended to recite “injection[[,]] paste”. In other words, a comma is missing between “injection” and “paste”.
Appropriate correction is appreciated.
Claim Interpretation
Claim 1 contains the term “mesenchymal passage cells” in line 12. Similarly, Claim 18 contains the term “mesenchymal passage cells” in line 3. This term is not a standard or a commonly used term in the art. The term “mesenchymal passage cells” will be interpreted to mean primary mesenchymal stem cells that have been passaged in culture based on the description in the specification in para. 0105 of the published application which describes the passage culture of primary mesenchymal stem cells.
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 12-17, 20-21, and 27 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.
In claim 12, line 2, the phrase "mesenchymal stem cells" lacks sufficient antecedent basis and renders the claim and its dependents indefinite. Claim 1 recites mesenchymal passage cells and not mesenchymal stem cells.
Since claims 13-17 depend from indefinite claim 12 and does not clarify the above points of confusion, claim 13-17 must also be rejected under 35 USC § 112, (b) or second paragraph (pre-AIA ).
The term “rpm” in claims 14, 16, 20 and 21 is a relative term which renders the claim indefinite. The term “rpm” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “rpm” refers to revolutions per minute which varies depending on the size of the centrifuge. It is advised that the relative centrifugal force (rcf) be used instead. However, it is noted that this may potentially introduce new matter depending on the disclosure.
In claim 27, line 2, the phrase "the administration method of the combination" lacks sufficient antecedent basis and renders the claim and its dependents indefinite. Claim 25 from which claim 27 depends from recites a neural repair composition and not an administration method of a combination.
Appropriate correction is required.
Claims 1, 12-21 and 24-27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01.
The omitted elements are: the components comprising the neural repair protein composition. Claim 1 is a product claim directed to a neural repair protein composition. However, the claims lacks positive structural components forming the composition and only defines the product by how the protein composition is produced. There are no physical structures or components disclosed or claimed. Instead the claim recites method steps for producing a cell protein extract. For the sake of compact prosecution the claim will be interpreted to mean that the neural repair protein composition comprises a cell extract from mesenchymal stem cells.
Similarly, claim 18 is a product claim directed to a cell protein extract. However, the claims lacks positive structural components forming the composition and only defines the product by how the cell protein extract is produced. There are no physical structures or components disclosed or claimed. Instead the claim recites method steps for producing a cell protein extract. For the sake of compact prosecution the claim will be interpreted to mean that the neural repair protein composition comprises a cell extract from mesenchymal stem cells.
All other claims depend directly or indirectly from rejected claims and are, therefore, also rejected under USC 112 for the reasons set forth above.
Appropriate correction is required.
Claim Rejections - 35 USC § 102/103
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.
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.
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, 12-21 and 24-27 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Nishikawa et al. (Digestive Diseases and Sciences, 2021).
With respect to claim 1, Nishikawa teaches that MSC (mesenchymal stem cell) lysate contains anti-inflammatory and regenerating factors and has been reported to have anti-apoptotic activity that reduces tissue damage by inhibiting apoptosis and promotes regeneration (pg. 1035 Col. 1 last para.). Nishikawa further teaches a protein composition containing MSC lysate (pg. 1035 Col. 2 para. 1).
Although Nishikawa does not teach the method by which the protein composition is made as recited in claims 1, 12-16, and 18-21, these limitations are interpreted as product by process type limitations. It is noted that the patentability of a product does not depend on its method of production. If the claimed product is the same or obvious from a product in the prior art (i.e. the product disclosed in the cited reference), the claim is unpatentable even though the reference product was made by a different process. When the prior art discloses a product which reasonably appears to be identical with or slightly different than the claimed product-by-process, rejections under 35 U.S.C 102 and/or 35 U.S.C 103 are proper. (MPEP 2113)
Nishikawa is silent with respect to the molecular weight of the neural protein composition and does not teach that it is 20-250 kDa as recited in claim 17. Nishikawa is silent as to whether the composition has neural repair efficacy as recited in claims 18 and 24. The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not applicants' protein composition differ, and if so to what extent, from the protein composition of Nishikawa. Nishikawa’s protein composition is the same or similar because it is lysate from mesenchymal stem cells which have been expanded in culture as claimed by applicant. Additionally, Nishikawa teaches that MSC lysate contains anti-inflammatory and regenerating factors and has been reported to have anti-apoptotic activity that reduces tissue damage by inhibiting apoptosis and promotes regeneration which would aid in neural repair (pg. 1035 Col. 1 last para.). In further support, Nishikawa teaches filtering the MSC lysate a 0.2 µm membrane filter (pg. 1035 Col. 2 para. 1). The cited art taken as a whole demonstrates a reasonable probability that the protein composition of Nishikawa is either identical or sufficiently similar to the claimed protein composition that whatever differences exist are not patentably significant. Therefore, the burden of establishing novelty or unobviousness by objective evidence is shifted to applicants. Clear evidence that the method for producing protein composition of the cited prior art does not possess a critical characteristic that is possessed by the claimed method (for example, Nishikawa does not have a molecular weight of 20 to 250 kDa or does not repair neural tissue) would advance prosecution and might permit allowance of claims to applicants' protein composition.
Nishikawa does not teach the intended use of the composition for neural repair as recited in claim 1. Similarly, Nishikawa does not teach the composition for an administration method of intravenous injection, intrathecal injection, lumbar puncture or combination thereof as recited in claim 27. Although Nishikawa does not teach these claimed uses of the protein composition, the protein composition of Nishikawa is the same as that claimed by applicant. Thus, the intended use of the protein composition is also inherent in the protein composition of Nishikawa. It is noted that the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112).
With respect to claims 24 and 25, Nishikawa teaches the composition containing the cell protein extract and phosphate-buffered saline (PBS), a pharmaceutically acceptable carrier (pg. 1036 Col. 1 para. 1). With respect to claim 26, Nishikawa teaches the composition for injection (pg. 1036 Col. 1 para. 1).
Therefore, the invention reference anticipates the claimed subject matter or the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp
Claims 1, 12-21 and 24-27 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 3, 5-6, 10, 14 and 17-18 of copending Application No. 18/833708. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims encompass those of the copending patent application.
In addition, both claim protein compositions and the limitations of instant claims 1 and 18, are recited by claims 1 and 14 of Appl. No. 18/833708 which disclose a protein composition for repairing hair follicles where the steps of preparing the composition are nearly identical to the claimed steps of preparing.
The claims of Appl. No. 18/833708 do not recite the same period of time (2 to 6 hours) of culturing the mesenchymal passage cells with the stressor in step S-1 and recite a period of 10 to 60 minutes. Even though the claims of Appl. No. 18/833708 do not recite the exact ranges recited in the instant claims, one of ordinary skill in the art would recognize that the period of culturing a cell population with a stressor is a result effective variable and that the time period would be matter of routine optimization depending on the culture conditions and intended outcome.
It is noted that the claims of Appl. No. 18/833708 do not recite that the protein composition can be used in the manner instantly claimed for the neural repair as recited in claim 1. However, in claim 1 the preamble fails to limit the structure of the claimed invention and the statement is considered a statement of purpose or an intended use of the corresponding inventions. “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction”. (MPEP 2111.02 Section II) In the instant case, the claim body describes a structurally complete invention in which the deletion of the preamble would not affect steps of the claimed invention.
Additionally, the claims of Appl. No. 18/833708 do not recite that the cell protein extract has neural repair efficacy as recited in claim 18. However, the claims recite the claimed composition, therefor, this should be an inherent characteristic of the cell protein extract of the claims of Appl. No. 18/833708.
The claims of Appl. No. 18/833708 do not recite the density of the mesenchymal stem cell in step S-1 is 8.0x106 to 1.0x107 cells/mL as recite in claim 12. Although the claims of Appl. No. 18/833708 do not teach the exact ranges recited in claim 12, the range (5.0x106 to 1.0x107 cells/mL, see claim 1 of Appl. No. 18/833708) overlap significantly with the claimed range. Furthermore, one of ordinary skill in the art would recognize that the cell density is a result effective variable and that the cell density of a cell culture would be matter of routine optimization depending on the conditions and desired outcomes.
With respect instant claims 13 and 19, claim 5 of Appl. No. 18/833708 recites conditions for sonicating of step S-2 are: operating at 2°C-8°C, 25kHZ, 360W for 3 seconds with a gap of 1 second, and sonicating for 1-5 minutes.
With respect to instant claims 14 and 20, claim 10 of Appl. No. 18/833708 recites the separating in step S-3 is a centrifugation of 2000-8000rpm * 10-30min.
With respect instant claims 15, 16 and 21, claim 10 of Appl. No. 18/833708 recites the separating in step S-3 is a multi-stage centrifugation, and the multi-stage centrifugation is sequentially 3000-4000 rpm*3-5 minutes, 5000-6000 rpm*3-5 minutes, and 7000 rpm*5-8 minutes.
With respect instant claim 17, claim 3 of Appl. No. 18/833708 recites the molecular weight of the protein composition for repairing hair follicles is 20kDa to 300kDa which overlaps significantly with the claimed range of 20-200 KDa.
With respect instant claims 24, 25 and 26, claims 6 and 17 of Appl. No. 18/833708 recites a freeze dried protectant and claim 9 recites a pharmaceutically acceptable carrier.
With respect instant claim 26, claim 18 of Appl. No. 18/833708 recites the composition is selected from any kind of freeze-dried preparation, gel, nasal spray, paste, cream, emulsion, liquid dressing, injection and suppository.
Although the claims of Appl. No. 18/833708 do not teach the claimed use of the composition of administering the composition by one or a combination of intravenous injection, intrathecal injection, or lumber puncture as recited in claim 27, the protein composition of the claims of Appl. No. 18/833708 are the same as those instantly claimed. Thus, the intended use of the protein composition of the claims of Appl. No. 18/833708 is also inherent in the protein composition of the claims of Appl. No. 18/833708. It is noted that the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting.
Claims 1, 12-21 and 24-27 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 3, 9, 13, 16-17, 20-21 and 23-24 of copending Application No. 18/833909. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims encompass those of the copending patent application.
In addition, both claim protein compositions and the limitations of instant claims 1 and 18, are recited by claims 1 and 24 of Appl. No. 18/833909 which disclose a protein composition having cell repair effect where the steps of preparing the composition are nearly identical to the claimed steps of preparing.
The claims of Appl. No. 18/833909 do not recite the same period of time (2 to 6 hours) of culturing the mesenchymal passage cells with the stressor in step S-1 and recite a period of 10 minutes to 14 hours. Even though the claims of Appl. No. 18/833909 do not recite the exact ranges recited in the instant claims, one of ordinary skill in the art would recognize that the period of culturing a cell population with a stressor is a result effective variable and that the time period would be matter of routine optimization depending on the culture conditions and intended outcome.
With respect to instant claims 1 and 12, claim 3 of Appl. No. 18/833909 recites the density of the mesenchymal passaged cells for step S-1 is 2.0x106 to 2.0x107 cells/mL and claim 13 of Appl. No. 18/833909 recites the density of the mesenchymal passaged cells for step 1 is 5.0x106 to 1.0x107 cells/mL. The claims of Appl. No. 18/833909 do not recite the density of the mesenchymal stem cell in step S-2 is 5.0x106 to 5.0x107 cells/mL as recite in claim 1 and do not recite the density of the mesenchymal stem cell in step S-1 is 5.0x106 to 5.0x107 cells/mL and in step S-2 is 5.0x106 to 5.0x107 cells/mL as recite in claim 18. Although the claims of Appl. No. 18/833909 do not teach the exact ranges recited in claims 1, 12 and 18, the ranges (step S-1 of 5.0x106 to 1.0x107 cells/mL, see claim 1 of Appl. No. 18/833909 and step S-2 of 5.0x106 to 1.0x107 cells/mL) overlap significantly with the claimed range. Furthermore, one of ordinary skill in the art would recognize that the cell density is a result effective variable and that the cell density of a cell culture would be matter of routine optimization depending on the conditions and desired outcomes.
With respect instant claims 24 and 25, claim 9 of Appl. No. 18/833909 recites a pharmaceutically acceptable carrier.
With respect instant claims 14 and 20, claim 16 of Appl. No. 18/833909 recites the separation described in step S-3 is selected from any one or a combination of 2000-8000rpm, 10-30min centrifugation, multi-stage centrifugation, and multi-stage filtration.
With respect instant claims 15, 16 and 21, claim 17 of Appl. No. 18/833909 recites the separating in step S-3 is a multi-stage centrifugation, and the multi-stage centrifugation is sequentially 3000-4000 rpm*3-5 minutes, 5000-6000 rpm*3-5 minutes, and 7000 rpm*5-8 minutes. With respect instant claim 26, claim 20 of Appl. No. 18/833909 recites the composition is selected from any kind of freeze-dried preparation, gel, nasal spray, paste, cream, emulsion, liquid dressing, injection and suppository. With respect instant claim 27, claim 21 of Appl. No. 18/833909 recites the administration method of the composition is selected from intravenous injection and lumbar puncture.
With respect to instant claims 1 and 18, claim 23 of Appl. No. 18/833909 recites the cell repair composition is capable of being incorporated into a medication or product for the cell repair of nerve damage.
Although, the claims of Appl. No. 18/833909 do not recite the limitations of claims 13, 17 and 19. Although, the claims of Appl. No. 18/833909 do not teach the method by which protein composition is made as in claims 13, 17 and 19, these limitations are interpreted as product by process type limitations. It is noted that the patentability of a product does not depend on its method of production. If the claimed product is the same or obvious from a product disclosed in the cited reference (the claims of Appl. No. 18/833909), the claim is unpatentable even though the reference product was made by a different process.
Claims 1, 12-21 and 24-27 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 9, 11-15, 17-21 and 24 of copending Application No. 18/833860. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims encompass those of the copending patent application.
In addition, both claim protein compositions and the limitations of instant claims 1 and 18, are recited by claims 1, 17 and 18 of Appl. No. 18/833860 which disclose a protein composition having a joint repair function where the steps of preparing the composition are nearly identical to the claimed steps of preparing.
The claims of Appl. No. 18/833860 do not recite the same period of time (2 to 6 hours) of culturing the mesenchymal passage cells with the stressor in step S-1 and recite a period of 10 to 14 hours. Even though the claims of Appl. No. 18/833860 do not recite the exact ranges recited in the instant claims, one of ordinary skill in the art would recognize that the period of culturing a cell population with a stressor is a result effective variable and that the time period would be matter of routine optimization depending on the culture conditions and intended outcome.
The claims of Appl. No. 18/833860 do not recite the density of the mesenchymal stem cell in step S-2 is 5.0x106 to 5.0x107 cells/mL as recite in claim 1; do not recite the density of the mesenchymal stem cell in step S-1 is 5.0x106 to 5.0x107 cells/mL and in step S-2 is 5.0x106 to 5.0x107 cells/mL as recite in claim 18; and do not recite the density of the mesenchymal stem cell in step S-1 is 8.0x106 to 1.0x107 cells/mL as recited in instant claim 12. However, claim 11 of Appl. No. 18/833860 recites the density of the mesenchymal passaged cells in step S-1 is 6.0x106 to 2.0x107 cells/mL and claim 1 recites the density of the mesenchymal stem cell in step S-1 of 5.0x106 to 5.0x107 cells/mL and in step S-2 of 5.0x106 to 1.0x107 cells/mL. Although the claims of Appl. No. 18/833860 do not teach the exact ranges recited in claims 1, 12 and 18, the ranges overlap significantly with the claimed range. Furthermore, one of ordinary skill in the art would recognize that the cell density is a result effective variable and that the cell density of a cell culture would be matter of routine optimization depending on the conditions and desired outcomes.
With respect instant claims 13 and 19, claim 12 of Appl. No. 18/833860 recites conditions for sonicating of step S-2 are: operating at 2°C-8°C, 25kHZ, 360W for 3 seconds with a gap of 1 second, and sonicating for 1-5 minutes.
With respect instant claims 14 and 20, claim 13 of Appl. No. 18/833860 recites the separation described in step S-3 is selected from any one or a combination of 2000-8000rpm, 10-30min centrifugation, multi-stage centrifugation, and multi-stage filtration.
With respect instant claims 15, 16 and 21, claim 14 of Appl. No. 18/833860 recites the separating in step S-3 is a multi-stage centrifugation, and the multi-stage centrifugation is sequentially 3000-4000 rpm*3-5 minutes, 5000-6000 rpm*3-5 minutes, and 7000 rpm*5-8 minutes.
With respect instant claim 17, claim 15 of Appl. No. 18/833860 recites the molecular weight of the protein composition for repairing hair follicles is 25kDa to 245kDa which overlaps significantly with the claimed range of 20-200 KDa.
With respect instant claims 24 and 25, claims 9 and 19 of Appl. No. 18/833860 recites a pharmaceutically acceptable carrier.
With respect instant claim 26, claim 20 of Appl. No. 18/833860 recites the composition is selected from any kind of freeze-dried preparation, gel, nasal spray, paste, cream, emulsion, liquid dressing, injection and suppository.
With respect instant claim 27, claim 21 of Appl. No. 18/833860 recites the administration method of the composition is selected from intravenous injection and lumbar puncture.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 EST.
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/EMILY A CORDAS/Primary Examiner, Art Unit 1632
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