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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 3, 2025, has been entered.
DETAILED ACTION
Applicant’s response filed March 3, 2025, has been considered. Rejections and/or objections not reiterated from the previous office action mailed December 2, 2024, are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The amended claims filed on March 3, 2025, have been acknowledged. Claims 2 and 8-10 were cancelled. Claims 1, 4-7, 11, and 13-15 were amended. Claims 1, 3-7, and 11-15 are pending and examined on the merits.
Priority
Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. 119(a)-(d).The applicant claims foreign priority from CN201910100503.9 filed on January 31, 2019. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55, received August 02, 2021 and a certified translation received on February 3, 3025. Claims 1, 7-10, and 14-18 find support in foreign application CN201910100503.9 filed on January 31, 2019.
Claim Objections
Claim 4-5 and 7 are objected to because of the following informalities:
In claims 4, lines 1-2, “the organoid contains stem cells” should read “the organoid contains a stem cell”.
In claims 5 and 7, line 3, “dorsal muscle of abdominal cavity” should read “dorsal muscle of the abdominal cavity” as the abdominal cavity is an inherent feature of the animal or human.
Appropriate correction is required.
Claim Interpretation
Claims 1-5 and 11-12 are product claims with two interpretations for the product.
The first interpretation is that the product is the biomaterial and the active substance. Under this interpretation, the biomaterial and the active substance are the only structural components. Claims 1 and 11-12 follow this interpretive path as they focus on the biomaterial and the active substance.
The second interpretation is that the product is the organoid (stem cell generator) created by the body after implantation. Under this interpretation, the only structural component is the organoid containing stem cells (stem cell generator). Under this interpretation, the claim is not directed to the implanted material but to the resulting product created by the body.
Withdrawn Claim Rejections - 35 USC § 112(b)
The prior rejection of claim 4 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 is withdrawn in light of Applicant’s amendment to claim 4 to recite the organoid contains stem cell and identifies the type of stem cell.
The prior rejection of claims 5 and 7 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 is withdrawn in light of Applicant’s amendments to claims 5 and 7 to recite “a muscle pocket”.
New 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 1, 3-7, and 11-15 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 1, 6, and 13 recite the limitation “a biomaterial containing only an active substance”. A biomaterial is not inherently container like. As such, there is an unknown association between the active substance (the contained substance) and the biomaterial (the container). For example, if an active substance is bound to the outside of a biomaterial, it’s unclear whether this would be considered contained by the biomaterial.
Claims 3-5 and 11-12 are also rejected because of their dependency on claim 1. Claim 7 is also rejected because of its dependency on claim 6. Claims 14-15 are also rejected because of their dependency on claim 13.
Regarding claim 1, 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 1 recites the broad recitation “a stem cell generator, and the claim also recites the organoid 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.
Claims 3-5 and 11-12 are also rejected because of their dependency on claim 1.
Regarding claim 3, where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “pluripotent stem cells” in claim 3 is used by the claim to mean “multipotent or pluripotent stem cells” as the specification provides examples of pluripotent stem cells that include multipotent stem cells such as hematopoietic stem/progenitor cells (HSC/HPC) and mesenchymal stem cells (MSC) (specification page 2, paragraph 5) while the accepted meaning is “pluripotent (i.e. differentiates into all three germ layers)” while multipotent stem cells are further differentiated stem cells with more limited differentiation patterns compared to pluripotent stem cells. The term is indefinite because the specification does not clearly redefine the term.
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 5 and 11-12 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.
Under the interpretation that the product is the stem cell generator, claim 5 fails to further limit the stem cell generator as claim 1 is a product-by-process and the implantation sites recited in claim 5 are considered process limitations that do not limit the structure of the stem cell generator.
Under the interpretation that the product is the stem cell generator, claims 11-12 fail to further limit the stem cell generator as claim 1 is a product-by-process and the limitations to the composition of the biomaterial and the ratio of the biomaterial to the active substance are considered process limitations that do not limit the structure of the stem cell generator.
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 § 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, 3-5 and 11-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. Section 33(a) of the America Invents Act reads as follows: Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1, 3-5, and 11-12 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Furthermore, claim 1 is interpreted as a product-by-process claim. As such, only the positively recited structures of the stem cell generator are considered germane to the patentability of the device. The recited structures of the stem cell generator are considered:
a. A 3 week old organoid
b. Comprises stem cells
The recitation of a process limitation in claim 1 is not viewed as positively limiting the claimed product absent a showing that the process of making recited in claim 1 (i.e. implanting a biomaterial containing only an active substance) imparts a novel or unexpected property to the claimed product, as it is assumed that equivalent products are obtainable by multiple routes. The burden is placed upon the applicants to establish a patentable distinction between the claimed and referenced products. The method in which the organoid was produced is immaterial to their patentability.
"Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). See also MPEP §2113.
In the instant case the scope of invention as claimed (see claim 1) is drawn to a stem cell generator that generates a 3 week old organoid comprising stem cells, which encompasses humans as blastocysts implanted into humans generate a 3 week old organoid comprising stem cells.
For IVF and embryo transfer, blastocysts (Embryonic day 5) are transferred and implant into the uterus. Wikipedia (Human Embryonic Development) shows that by embryonic day 21 (16 days post transfer), the developing embryo and extra-embryonic tissue has begun differentiating into distinct organs, such as the amniotic sac, placenta, the heart, and the digestive system (page 1, Figure: The initial stages of human embryogenesis, page 3, paragraphs 2-3, and page 6, paragraph 6-page 7, paragraph 1 and Figure: Development of the Heart, and page 7, paragraph 1).
As such, a developing embryo would read on a 3 week old organoid comprising stem cells. It is PTO policy not to allow claims to humans (supra).
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, 4-5, and 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wikipedia (Human Embryonic Development. 2018).
Regarding claim 1, claim 1 is interpreted as a product-by-process claim. As such, only the positively recited structures of the stem cell generator are considered germane to the patentability of the device. The recited structures of the stem cell generator are considered:
a. A 3 week old organoid
b. Comprises stem cells
The recitation of a process limitation in claim 1 is not viewed as positively limiting the claimed product absent a showing that the process of making recited in claim 1 (i.e. implanting a biomaterial containing only an active substance) imparts a novel or unexpected property to the claimed product, as it is assumed that equivalent products are obtainable by multiple routes. The burden is placed upon the applicants to establish a patentable distinction between the claimed and referenced products. The method in which the organoid was produced is immaterial to their patentability.
"Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). See also MPEP §2113.
For IVF and embryo transfer, blastocysts (Embryonic day 5) are transferred and implant into the uterus. Wikipedia (Human Embryonic Development) shows that by embryonic day 21 (16 days post transfer), the developing embryo and extra-embryonic tissue has begun differentiating into distinct organs, such as the amniotic sac, placenta, the heart, and the digestive system (page 1, Figure: The initial stages of human embryogenesis, page 3, paragraphs 2-3, and page 6, paragraph 6-page 7, paragraph 1 and Figure: Development of the Heart, and page 7, paragraph 1).
As such, a developing embryo would read on a 3 week old organoid comprising stem cells.
Regarding claim 4, Wikipedia (Human Embryonic Development) teaches that gastrulation occurs at embryonic day 17, which is when mesenchymal stem cells begin to form (page 4, paragraph 4-page 5, paragraph 1). As such, the 26 day old embryo (3 weeks since transfer) would include mesenchymal stem cells.
Regarding claims 5 and 11-12, as these are considered process claims and do not provide additional structural limitations to the stem cell generator, these claims are also rejected based on the developing embryo.
Claims 1, 3-5, and 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kusumoto et al. (British Journal of Plastic Surgery 51: 275-280. 1998).
Regarding claims 1 and 5, under the first interpretation wherein the product is the biomaterial and the active substance, Kusumoto teaches that they mixed recombinant BMP-2 (the active substance) with collagen (the biomaterial) and compressed it in a syringe to form a disk. Kusumoto teaches that they implanted the BMP-2 and collagen disk into a muscle pocket of the latissimus dorsi muscle flap (abstract and page 275, column 2, paragraph 2-page 276, column 1, paragraph 2).
Regarding claim 11, Kusumoto, as stated supra, teaches that they used collagen as the biomaterial (abstract).
Regarding claim 12, Kusumoto teaches that they mixed 2, 10 or 50 μg of BMP-2 with 3 mg of collagen (page 275, column 2, paragraph 5-page 276, column 1, paragraph 1). This equates to a ratio of BMP-2 to collagen of 0.0006:1, 0.003:1, and 0.016:1, respectively. Each are within the mass ratio recited in claim 12.
Regarding claims 1 and 5, under the second interpretation wherein the product is the organoid (stem cell generator) created by the body 3 weeks after implantation, Kusumoto teaches that they mixed recombinant BMP-2 (the active substance) with collagen (the biomaterial) and compressed it in a syringe to form a disk. Kusumoto teaches that they implanted the BMP-2 and collagen disk into a muscle pocket of the latissimus dorsi muscle flap. After three weeks, there was ectopic osteoinduction at the site of implantation and the tissue was removed for histological examination (abstract and page 275, column 2, paragraph 2-page 276, column 2, paragraph 3). Kusumoto teaches that 3 weeks post-implantation, new bone tissue (i.e. a bone organoid) formed at the site of implantation. A mass of implanted collagen fibers was observed at the center of the lump. Osteoblasts lined the central side of trabeculae in a single line. A few osteoclasts directly contacted the trabecular bone. At the central side of the trabeculae, bone marrow partially containing angioid tissue was observed in some places. Angioid structures containing a circle of intimal cells and pooled red cells, were scattered throughout the mass (i.e. the lump consisted of trabeculum, bone marrow and remnants of collagen fibers) (page 276, column 2, paragraph 7 and Figure 4). As such, a bone organoid was formed.
Regarding claims 3-4, as stated in the 112b rejection above, “pluripotent” is considered to include multipotent stem cells such as HSCs/HSPCs and MSCs. Figure 4 of Kusumoto shows that the newly produced bone organoid contains a bone marrow region. As such, the newly formed bone organoid would include bone marrow cells in the bone marrow region and hematopoietic stem and progenitor cells (identified as a pluripotent stem cell by the Applicant) as these cells are known to reside in and be important for the development and maintenance of bone marrow.
Claims 6-7 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kusumoto et al. (British Journal of Plastic Surgery 51: 275-280. 1998).
Kusumoto teaches that they mixed recombinant BMP-2 (the active substance) with collagen (the biomaterial) and compressed it in a syringe to form a disk. Kusumoto teaches that they implanted the BMP-2 and collagen disk into a muscle pocket of the latissimus dorsi muscle flap. After three weeks, there was ectopic osteoinduction at the site of implantation and the tissue was removed for histological examination (abstract and page 275, column 2, paragraph 2-page 276, column 2, paragraph 3). Kusumoto teaches that 3 weeks post-implantation, new bone tissue (i.e. a bone organoid) formed at the site of implantation. A mass of implanted collagen fibers was observed at the center of the lump. Osteoblasts lined the central side of trabeculae in a single line. A few osteoclasts directly contacted the trabecular bone. At the central side of the trabeculae, bone marrow partially containing angioid tissue was observed in some places. Angioid structures containing a circle of intimal cells and pooled red cells, were scattered throughout the mass (i.e. the lump consisted of trabeculum, bone marrow and remnants of collagen fibers) (page 276, column 2, paragraph 7 and Figure 4). As such, a bone organoid was formed that could be used as a bone graft/filler or bone repair material.
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.
Claim 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Kusumoto et al. (British Journal of Plastic Surgery 51: 275-280. 1998).
The teachings of Kusumoto are as discussed above.
Although Kusumoto teaches making a bone organoid that is excised after three weeks, Kusumoto does not perform the step of administering the bone repair material (the bone organoid) to a subject.
However, Kusumoto directly contemplates that their bone organoid generates a prefabricated flap including bone (PFFIB) and that PFFIBs can be grafted along with the surrounding soft tissue to treat a skeletal defect due to fracture (i.e. trauma-induced bone defect) (page 275, column 1, paragraph 1-column 2, paragraph 2).
As such, it would have been obvious to perform the additional step of administering the bone organoid (the PFFIB) of Kusumoto to a patient with a trauma induced skeletal defect as it is directly contemplated by Kusumoto that PFFIBs can be used in this manner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEENAN A BATES whose telephone number is (571)270-0727. The examiner can normally be reached M-F 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Doug Schultz can be reached on (571) 272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KEENAN A BATES/Examiner, Art Unit 1631
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631
/DANIEL M SULLIVAN/Director, Technology Center 1600