DETAILED ACTION
Claims 1-17 are pending and under examination in the instant application. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . An action on the merits follows.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/10/24, 11/4/24, and 4/29/26 are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the information disclosure statements have been considered by the examiner, and initialed and signed copies of the 1449s are attached to this action.
Claim Objections
Claims 1-17 are objected to because of the following informalities: the claims are identified with claim numbering that does not conform to claim number practice. The claims are identified as “ [Claim 1]”, “ [Claim 2]”, etc. Claim numbers, however, should be set forth simply as sequential numbers followed by a period. For example, a claim listing with two claims would list:
1. Claim text
2. Claim text
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-17 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.
Independent claim 1 recites, “[c]ells for burn treatment that are used in treatment of a burn and are characterized by being placenta-derived cells of an animal, including a human, and promoting healing”. It is unclear as written whether the claim is drawn to a product which is cells with an intended use for treatment of a burn, or whether the claim is drawn to a method of burn treatment. The recitation of cells “that are used in treatment of a burn” is confusing as it is written as an active method step, i.e. “are used in treatment”. If applicant intends to claim a cell product, it is suggested that applicant amend claim 1 to recite, “cells for use in the treatment of a burn”. If applicant intends to claim a method for burn treatment, then applicant is advised to amend the claims to recite a method of burn treatment with specific method steps. Claim 1 is further indefinite in the use of the phrase “are characterized by”. This phrase is confusing as it seems to imply a method step of characterization of cells. Alternatively, if this phrase is being used to identify the type of cell, then it is suggested that applicant amend the claim to recites cells, “which are placenta-derived cells”. In addition, the phrase “and promoting healing” is further indefinite as it is unclear whether this is intended to be a method step, as it is in the present verb tense, or whether the applicant intends to recite a functional feature of the cells or an intended use of the cells. Thus, for the reason listed above, claim 1 as a whole is indefinite such that the metes and bounds of the claim cannot be determined. Claims 2-9 depend on claim 1 and thus are included in this rejection.
Claim 2 is further indefinite in the use of the phrase “characterized by” which could be interpreted being either method step or a recitation of a functional characteristic, and is thus confusing. It is suggested that applicant amend claim 2 to recite, “The cells for burn treatment of claim 1, wherein the cells comprise amniotic mesenchymal stem cells”.
Claims 3 and 4 are drawn to what appear to be a product which is cells, but which are rendered indefinite by the recitation of “characterized by” followed by what appear to active method steps of “being used for issue regeneration” and “promoting granulation formation” (claim 3), or “by regenerating tissue for a burn and having anti-bacterial and anti-inflammatory effects” (claim 4). As it is unclear whether these claims are product or method claims, the metes and bounds of these claims cannot be determined. If these limitations are supposed to be intended use of the cells then it is suggested that applicant the claims to recite instead, “which are capable of being used for used for tissue regeneration for a burn…or for the promotion of granulation formation” (claim 3), or for claim 4, “which are capable of regenerating tissue for a burn and which have anti-bacterial and anti-inflammatory effects.
Claims 5-6 and 8-9 are further indefinite for the following reasons. Claim 5 is indefinite for reciting that cells, “characterized by being included in a solvent”. As explained above, the phrase “characterized by” could be interpreted as either a method step or as a reference to an additional physical limitation related to the cells or a functional property of the cells. If applicant intends to claim cells, then it is suggested that applicant amend claim 5 and also claim 6 which depends on claim 5 to delete “characterized by” and simply recite the additional limitation or the functional property, which for claim 5 would be that the cells “are present in a solvent”, and for claim 6, “wherein the solvent has high viscosity”. Likewise, for claims 8-9, which also recite “characterized by” followed by what appear to be functional properties, it is suggested these cells be amended to delete “characterized by” with a wherein clause, i.e. “wherein the cell are capable of ….”. or “wherein the burn dressing and/or burn regenerative scaffold is …”.
Claims 6 and 15 are further indefinite in the recitation of “the solvent having high viscosity” (claim 6) or “the solvent has high viscosity” (claim 15). The term “high” is a relative term of degree. In the absence of any comparative level of viscosity, it is unclear what constitutes a “high” level of viscosity. As such, the metes and bounds of the claims cannot be determined.
Independent claim 10 recites “A burn treatment method”. However, the claim is rendered indefinite because instead of reciting specific method steps, the claim recites, “characterized by promoting healing by placing placenta-derived cell from an animal, including a human , at a burn wound site”. The phrase “characterized by” is a confusing phrase that renders the claim indefinite as it is unclear whether the method has two steps where the first is “promoting healing” and the second is placing the cells at a burn wound site, or whether the “characterized by promoting healing” refers to the result of a singular method step which is placing the cells at a wound site. Thus, the metes and bounds of the claim cannot be determined. It is suggested that applicant delete the phrase “characterized by” and recite instead specific method steps and specific results or functional effects. For example, “A method of burn treatment comprising placing placenta-derived cells from an animal, including a human, at a burn wound site, thereby promoting healing”. Claims 11-17 depend on claim 10 and thus are included in this rejection.
For claims 11-17, all of which utilized the “characterized by” language, which as discussed in detail above, is indefinite in that it is unclear whether this phrase refers to an active method step, a limitation of a preceding claim element, a functional feature of claim element or activity, or an intended use. It is suggested, as above, that applicant replace “characterized by” with specific method steps as exemplified above, or specific “wherein” clauses which define additional limitations or functional activities, or specific “capable of” clauses which recite additional intended uses.
Claim Interpretation
While claims 1-17 have issues of indefiniteness under 35 U.S.C. 112(b) as discussed in detail above, these claims been given their broadest reasonable interpretation as reading on a product comprising placenta derived cells for claims 1-9, and a method of using the cells for burn treatment for claims 10-17. For claims 8 and 9, is noted that clause “capable of being used” has been given its broadest reasonable interpretation as a functional property of the cells in that they can be used alone or in combination with a burn dressing and/or a burn regenerative scaffold. Neither claim 8 nor claim 9, which further defines the nature of the burn dressing or regenerative scaffold, actually recites that the cells are present in combination with any additional element. As such, claims 8 and 9 are interpreted as reading on the cell product by itself.
In addition, the following claim interpretation has been applied to the term “solvent” as recited in claims 5-6 and 12-15. Since the specification does not provide a specific definition for “solvent”, the term has been given its broadest reasonable interpretation based on it’s common dictionary definition as noun meaning “a usually liquid substance capable of dissolving or dispersing one or more other substances” - see the definition of solvent in the Merriam Webster online dictionary. https://www.merriam-webster.com/dictionary/solvent, accessed on 8/27/26, pages 1-9, see page 1). As such, the term “solvent” has been interpreted as encompassing any liquid capable of dispersing cells.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception which is a product of nature without significantly more. As noted in the discussion of claims 1-9 above under 35 U.S.C. 112(b) and claim interpretation, these claims have been interpreted as reading on a product which is cells. Independent claim 1 recites cells “characterized by being placenta-derived cells of an animal”. Claim 2 limits the cells to amniotic mesenchymal stem cells. Claim 3-4 and 7-9 recite intended uses or functional features of the cells. Claims 5-6 recite that the cells are in a solvent (claim 5), or a solvent with high viscosity (claim 6). As discussed above in the rejection of claim 6 under 35 U.S.C. 112(b), it is unclear what constitutes “high” viscosity. The cells as claimed are not identified as being “isolated” or removed from a host animal. As such, the claims read on amniotic mesenchymal stem cells present in an animal. Note as well that the physiological environment of the amnion serves as a “solvent” for the cells, and can further be considered a “high” viscosity solvent compared to water. Further, in so far as the claims may encompass isolated amniotic mesenchymal stem cells, there is no evidence that the process of isolation of these cells materially changes the structure or physical properties of the isolated cells from those found naturally in the body of an animal.
This judicial exception is not integrated into a practical application because the cells are claimed as products and are not part of a method of use of the cells in a specific practical application. Further, the cells as claimed do not include any additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim Rejections - 35 USC § 102
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.
Claims 1-5, 7-11, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (2019) Stem Cell Res. & Ther., Vol. 10:247, pages 1-17.
For claims 1-9, which have broadly interpreted as encompassing a product comprising placenta derived cells, it is noted that various recitations of the intended use of these cells in these claims must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Li et al. teaches isolated human amniotic membrane derived mesenchymal stem cells (hAMSCs) and methods of using said cells to treat a burn wound, and in particular a second degree burn wound (Li et al., pages 1, 4, and 6). More specifically, Li et al. teaches the subcutaneous administration of 2X10-6 hAMSCs suspended in 200 ul of PBS or media at the wound site resulting in significantly accelerated wound healing and closure compared to the injection of PBS alone or media alone (Li et al., pages 4, 6, and 17, and Figure 2). Note that 2X10-6 hAMSCs suspended in 200 ul of PBS is 500,000 hAMSCs per 50 ul of PBS. Note as well that PBS qualifies as “solvent” for cells. Thus, by teaching all the limitations of claims as written, Li et al. anticipates instant claims 1-5, 7-11, and 17.
Claims 1-15 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication 2019/0046573 (2019), hereafter referred to as Galue.
Galue teaches a composition comprising a cellular spraying compound comprising microvascular endothelial cells of skin and mesenchymal stem cells obtained from various tissues including amniotic mesenchymal stem cells resuspended in a regenerative solution for cellular implantation composed mainly of platelet-rich plasma alone or mixed with collagen type 1 and hyaluronic acid (Galue, paragraphs 10, 12, 23, and 103). Galue further teaches the addition of a second component to the cellular spraying compound which comprises human thrombin, CaCl2, a fibrinolytic agent, and a saline solution (Galue, paragraphs 14-15). Note that the solution in which the cells are suspended qualifies as a “solvent”. Galue teaches that the cellular spraying compound is applied to a cutaneous wound using a spray nozzle which can emit either fine or thick drops of the cellular regenerative solution which polymerize in the air such that a polymerized thee-dimensional network (Gel) comprising the cells is deposited on the cutaneous wound (Galue, paragraphs 15, 89, and 91-92). Note that a gel can be considered to have “high” viscosity compared to a liquid media. Galue further teaches that the cellular regenerative solution contains 10-100X10-6 resuspended mesenchymal stem cells per 1-100 ml, which can be expressed as between 500,000 mesenchymal stem cells per 50 ul of solution and 5,000,000 mesenchymal stem cells per 50 ul of solution, and that the spray application of this cellular spray solution deposits 10-100X10-6 mesenchymal stem cells in an even distribution over the skin lesion (Galue, paragraph 92). Finally, Galue teaches methods of treating a burn, including second or third degree burns, by spraying drops of the cellular spraying compound, i.e. “dripping” the cells in the solvent, onto a cutaneous burn lesion to treat the burn by promoting rapid re-epithelialization of the epidermis (Galue, paragraph 98-99). Thus, by teaching all the limitations of the claims as written, Galue anticipates the instant invention as claimed.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 10-17 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication 2019/0046573 (2019), hereafter referred to as Galue, in view of Oba et al. (2020) Burns & Trauma, Vol. 8, doi: 10.1093/burnst/tkaa014, pages 1-18, and Okabe et al. (2014) J. Biomed. Res. Part , Vol. 102A, 862-870.
Galue teaches a composition comprising a cellular spraying compound comprising microvascular endothelial cells of skin and mesenchymal stem cells obtained from various tissues including amniotic mesenchymal stem cells resuspended in a regenerative solution for cellular implantation composed mainly of platelet-rich plasma alone or mixed with collagen type 1 and hyaluronic acid (Galue, paragraphs 10, 12, 23, and 103). Galue further teaches the addition of a second component to the cellular spraying compound which comprises human thrombin, CaCl2, a fibrinolytic agent, and a saline solution (Galue, paragraphs 14-15). Note that the solution in which the cells are suspended qualifies as a “solvent”. Galue teaches that the cellular spraying compound is applied to a cutaneous wound using a spray nozzle which can emit either fine or thick drops of the cellular regenerative solution which polymerize in the air such that a polymerized thee-dimensional network (Gel) comprising the cells is deposited on the cutaneous wound (Galue, paragraphs 15, 89, and 91-92). Note that a gel can be considered to have “high” viscosity compared to a liquid media. Galue further teaches that the cellular regenerative solution contains 10-100X10-6 resuspended mesenchymal stem cells per 1-100 ml, which can be expressed as between 500,000 mesenchymal stem cells per 50 ul of solution and 5,000,000 mesenchymal stem cells per 50 ul of solution, and that the spray application of this cellular spray solution deposits 10-100X10-6 mesenchymal stem cells in an even distribution over the skin lesion (Galue, paragraph 92). Finally, Galue teaches methods of treating a burn, including second or third degree burns, by spraying drops of the cellular spraying compound, i.e. “dripping” the cells in the solvent, onto a cutaneous burn lesion to treat the burn by promoting rapid re-epithelialization of the epidermis (Galue, paragraph 98-99).
Galue differs from the method of instant claim 16 in that Galue does not teach to further cover the wound which has been sprayed with the mesenchymal stem cell regenerative gel solution with amniotic membrane, or more specifically with dried amniotic membrane, wherein the dried amniotic membrane has been dried to allow storage in air and so that epithelial cells, basement membrane, and connective tissue that compose the raw amniotic membrane are retained when the dried amniotic membrane is immersed in water or a buffer solution and rehydrated. Note that claim 16 depends on claim 10 such that this limitation is clearly an embodiment encompassed by the method of claim 10 and all its dependent claims. Oba et al. supplements Galue by teaching the use of hyper-dry amniotic membrane (HD-AM) as a wound dressing for third-degree burns (Oba et al., page 1). Oba et al. teaches that, “[s]evere burn injuries render the host susceptible to bacterial infection because of the large skin defects that are created. Burn wound infection often causes systemic sepsis and severe septicemia, resulting in an increase in mortality among patients with severe burn injuries” (Oba et al., page 2). Oba et al. teaches that the placement of HD-AM as a wound dressing after third-degree burn injury enhances the proliferation of granulation tissue, has both anti-inflammatory and anti-bacterial properties, improves moisture retention at the wound site, and promotes the migration of cells which improve the defense mechanisms against the entry of foreign substances which may improve patient survival (Oba et al., pages 2, and 14-15). Although Oba et al. does not provide a detailed description of the process for making HD-AM, Oba et al. cites Okabe et al. for methods of producing HD-AM. Okabe et al. teaches a detailed method for making HD-AM which involves drying the amniotic membrane using low pressure and irradiation without freezing, where the resulting dried AM exhibited substantially less degradation compared to freeze-dry methods of preparing dried AM (Okabe et al., page 863). Okabe et al. teaches that the HD-AM retained the morphological structure of the AM including the presence of epithelium and connective tissue (Okabe et al., page 866). Thus, Okabe et al. shows that the HD-AM used by Oba et al. retains the structural characteristics of the amniotic membrane.
Therefore, in view of the benefits to covering a third degree wound with HD-AM in order to enhances the proliferation of granulation tissue, improve moisture retention at the wound site, and promote the migration of cells which improve the defense mechanisms against the entry of foreign substances which may improve patient survival as taught by Oba et al., it would have been prima facie obvious to the skilled artisan at the time of filing to further cover the third degree burn wound site which has been sprayed with the mesenchymal stem cell regenerative solution according to Galue with the HD-AM taught by Oba et al. in order to protect the wound site from foreign substances and to enhance tissue granulation with a reasonable expectation of success.
No claims are allowed.
Any inquiry concerning this communication from the examiner should be directed to Anne Marie S. Wehbé, Ph.D., whose telephone number is (571) 272-0737. If the examiner is not available, the examiner’s supervisor, Maria Leavitt, can be reached at (571) 272-1085. For all official communications, the technology center fax number is (571) 273-8300. Please note that all official communications and responses sent by fax must be directed to the technology center fax number. For informal, non-official communications only, the examiner’s direct fax number is (571) 273-0737. For any inquiry of a general nature, please call (571) 272-0547.
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Dr. A.M.S. Wehbé
/ANNE MARIE S WEHBE/Primary Examiner, Art Unit 1634
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