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 .
Election/Restrictions
Applicant's election with traverse of Group I, drawn to claims 1-15, in the reply filed on 09/10/2025 is acknowledged. The traversal is on the ground(s) that the invention of Group II, drawn to claims 16-20, fall within the scope of the invention of Group I, and therefore examination of all claims does not present a serious search or examination burden. This is not found persuasive because independent claim 16 is drawn to a product comprising a frame configured to retain a mammalian tissue thereon (line 2), a limitation which is not present in the invention of Group I. Furthermore, independent claim 19 is drawn to a method comprising a step of shaping a mammalian mediastinal pleura tissue to fit around at least a portion of a frame (lines 2-3), a limitation which is not present in the invention of Group I. The requirement is still deemed proper and is therefore made FINAL.
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 09/10/2025.
Priority
The instant application is a Continuation of 14/847,695 filed 09/08/2015, which claims benefit of Provisional application 62/047,206 filed 09/08/2014.
Claim Interpretation
The method of claim 1 comprises three distinct steps (acquiring a tissue in line 2; selecting a sample in line 3; and fixing the sample in line 4). Claim 1, as written, does not limit the order in which these three steps are performed. Therefore, claim 1 is interpreted as a method of processing a tissue comprising the three steps as recited, wherein the steps may be performed in any order.
The word patient (claim 15, line 2) is not defined in the specification and is therefore given its broadest reasonable interpretation in the art, which is an animal receiving medical treatment.
Improper Markush Grouping Rejections
Claim 8 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claim 8 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the alternatives listed in claim 8 comprise tissue or organ covers, compositions used during surgery, and tissue replacement. These alternatives do not share a structural similarity; for example, a suture reinforcement is structurally different from a tissue replacement. Neither do these alternatives share a common use; for example, a suture reinforcement is used to add extra support and strength to a suture, whereas a tissue replacement is used in place of damaged or missing tissue.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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.
Claim 5 is 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. Claim 5 recites the phrase “a sample of mediastinal pleura tissue from a section of the parietal pleura tissue that extends between a pericardium and a diaphragm of the mammal” (lines 2-5). It is unclear what is meant by this phrase, as the mediastinal pleura does not extend between a pericardium and diaphragm (see “Heart in situ” diagram below, Encyclopaedia Britannica, 2010). For purposes of examination, this phrase is interpreted as “a sample of mediastinal pleura tissue from a section of the parietal pleura tissue that extends along a pericardium to a diaphragm of the mammal.”
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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.
Claim 4 is 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. Claim 4 is drawn to “The method of claim 1, wherein the step of selecting a sample of mediastinal pleura tissue further comprises isolating and harvesting a sample of mediastinal pleura tissue from a section of the parietal pleura tissue positioned between a right lung and a left lung of the mammal” (emphasis added). By definition, the mediastinal pleura is the section of the parietal pleura tissue positioned between a right and left lung (specification, p 6, para 2: As the mediastinal pleura separates the right and left lungs). The phrase “isolating and harvesting” (line 2) is implied in the phrases “acquiring a tissue” and “selecting a sample of mediastinal pleura tissue” in lines 1 and 2 of claim 1, respectively, and therefore does not further limit the method of claim 1. 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 § 112(a) Scope of Enablement
Claim 15 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for using the fixed sample of mammalian mediastinal pleural tissue in a surgical procedure to treat a patient of a compatible mammalian species, wherein the tissue has been formed into a product as recited in claim 8, does not reasonably provide enablement for treating a patient of any species using any mode of treatment, using the fixed sample of mediastinal pleural tissue. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to carry out the invention commensurate in scope with these claims.
Analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention without undue or unreasonable experimentation. See Mineral Separation v. Hyde, 242 U.S. 261, 270 (1916). The key word is 'undue,' not experimentation.' " (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. While all these factors are considered, a sufficient number are discussed below so as to create a prima facie case.
The nature of the invention: The nature of the invention is a method for treating a patient using a fixed sample of mammalian mediastinal pleura tissue.
The breadth of the claim:
Diseases and conditions, and mode of administration
The claim does not limit the diseases or conditions to be treated, or the mode of treatment. As written, the claim encompasses the treatment of any disease or condition, including tissue replacement and psychiatric disorders, using any mode of treatment, including surgical application and oral and intravenous administrations.
Cross-species treatment
The word patient (claim 15, line 2) is not defined in the specification and is therefore given its broadest reasonable interpretation in the art, which is an animal receiving medical treatment. The claim encompasses treating a patient of any animal species.
Therefore, the claim as a whole encompasses a method of treating any animal patient using the fixed sample of mediastinal pleura tissue, for any disease or condition and using any mode of treatment.
The state of the prior art:
Diseases and conditions, and mode of administration
The closest prior art is Kassab (WO 2013/120082 A1), which discloses a method for treating a patient using a fixed sample of pulmonary tissue, including visceral pleura tissue. Kassab teaches that the fixed tissue sample can be processed into medical articles, including a cover for stents, a patch, biological skin substitute, suture reinforcement, bladder and urethra tissue replacement, and muscle replacement (p 8, para 4; p 25). The medical articles taught in Kassab overlap with the products recited in instant claim 8. Kassab does not teach a method of treating a patient using a fixed sample of mammalian tissue, wherein the tissue has not been formed into a product for use in external and surgical application to the patient. The prior art does not teach, for example, treating neurological disorders using a fixed sample of mammalian tissue.
Cross-species treatment
At the effective filing date of the claimed invention (09/08/2014), the prior art on xenotransplantation is largely limited on discussion of the use of porcine tissue in primate patients. For example, Ekser (The Lancet, 2012, 379: 672-683) teaches that pigs provide an alternative source of tissue and cells for use in human transplantation (Abstract). Even then, issues such as development of thrombotic microangiopathy in the graft or systemic consumptive coagulopathy in the patient remains an issue (Abstract). Therefore, the porcine grafts tend to be structural tissues from which the pig cells have been removed, such that after transplantation, the tissues are repopulated with human recipient cells (Introduction, para 1).
Kassab does teach that pulmonary ligaments and visceral pleura can be harvested from any number of mammalian species and used in the same or different species (p 24, para 2). Kassab teaches that said tissue can be harvested from pigs, horses, cows, goats, sheep, etc., and used to treat the same species or different species, including humans (p 24, para 2). However, Kassab does not exemplify or reduce to practice said cross-species treatment.
The level of one of ordinary skill: One of ordinary skill in the art is a, research scientist holding a postgraduate degree or equivalent experience.
The level of predictability in the art:
Diseases and conditions, and mode of administration
The prior art teaches that products comprising fixed mammalian tissue can be used in surgical applications (e.g., Kassab, as discussed above). However, the prior art does not teach the use of fixed mammalian tissue to treat a broad range of conditions and diseases as claimed in claim 16. The prior art does not teach or suggest, for example, that fixed mammalian tissue can be used to treat a psychiatric disorder such as anxiety. Likewise, the prior art does not teach the use of fixed mammalian tissue for applications other than surgical uses, such as for formulation into an oral tablet or into a liquid I.V.
Cross-species treatment
The prior art teaches that porcine tissue may be used as xenotransplantation material in human patients (e.g., Ekser 2012, as discussed above). However, the prior art does not teach combinations and permutations of xenotransplantation within, or beyond, mammalian species. Within mammals, the prior art does not teach, for example, a method of treating a human patient using a platypus tissue sample. Moreover, the prior art does not teach the use of fixed mammalian tissue to treat a non-mammalian patient, such as a bird or snake.
Therefore, there was a high level of unpredictability regarding the use of a fixed sample of mammalian mediastinal pleura tissue to treat a patient, as encompassed in claim 15.
Working examples and the amount of guidance:
Diseases and conditions, and mode of administration
The specification recites that “The mammalian pulmonary ligament, the mammalian visceral pleura, and the mammalian mediastinal pleura, as referenced in detail below and disclosed within the present application, can be harvested, fixed, and used for a number of medical applications previously unknown and not identified in the medical arts” (p 5, para 2). The specification does show products formed from fixed mammalian mediastinal pleura (see, e.g., Figs 5A-D). The specification also provides examples of uses for such products (p 18-19), which are the products recited in claim 8. However, the specification does not provide guidance on what “medical applications previously unknown and not identified in the medical arts” may be, beyond the recitation of said products. The specification does not provide guidance on the formulation of fixed mammalian mediastinal pleura into a medication to be administered orally or intravenously into a patient, or non-surgical treatment of diseases or conditions.
Cross-species treatment
The specification recites that “mediastinal pleura tissue… can be harvested from any number of mammalian species and be used in the same or other species. For example, pulmonary ligaments 30, visceral pleura 556, and/or mediastinal pleura 38 tissue can be harvested from pigs, horses, cows, goats, sheep, etc. and used to treat the same species or different species, including humans” (p 17, para 1). However, this is merely a recitation of a prophetic embodiment; the specification does not exemplify or reduce to practice a method of cross-species treatment using a fixed mediastinal pleura tissue. Rather, the working examples given in the specification relate only to a method of processing mammalian mediastinal pleura tissue, rather than the use of said tissue for treating a patient.
The quantity of experimentation necessary:
Based on the content of the disclosure and the state of the prior art, undue experimentation is required to carry out the invention as claimed. As discussed above, the examples disclosed in the specification are limited to the manufacture of a product comprising mammalian mediastinal pleura tissue, and do not relate to the use of said product to treat a patient. The prior art does teach the use of a fixed mammalian tissue sample in certain surgical applications, but does not teach the use of said samples in non-surgical contexts, for the treatment of all conditions and diseases, or for all permutations of cross-species treatment.
Given the lack of guidance in the disclosure and the unpredictability of the art, additional experimentation is required to determine how to use a fixed mammalian mediastinal pleura tissue to treat conditions such as psychiatric disorders and viral infections. The experimentation required encompasses determining the route of administration, formulating the tissue into an appropriate product for application, and the determination of cross-species efficacy and tolerance. Therefore, in light of the breadth of the claims, the limited guidance in the specification with respect to the breadth, and the state of the art, undue experimentation is required to carry out the invention as broadly claimed.
In conclusion, the evidence provided in the disclosure, in light of the teachings available in the art, does not enable one skilled in the art to make the claimed invention without undue or reasonable experimentation. Therefore, the method recited in claim 15 is not enabled in its full breadth.
Claim Rejections - 35 USC § 112(a) Written Description
Claim 15 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
From M.P.E.P. § 2163, the analysis of whether the specification complies with the written description requirement calls for the examiner to compare the scope of the claim with the scope of the description to determine whether applicant has demonstrated possession of the claimed invention from the standpoint of one of skill in the art at the time the application was filed. For inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession.
For claims drawn to a genus, possession may be shown (for example) through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. A “representative number of species” means that the species which are adequately described are representative of the entire genus, and is an inverse function of the skill and knowledge in the art. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly. If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112, para. 1.
In the instant case, “treating a patient,” as encompassed by claim 15, lacks a written description. Claim 15 is drawn to the method of claim 1, further comprising the step of treating a patient using the fixed sample of mediastinal pleura tissue. Neither treatment nor patient is defined in the instant specification. Therefore, as claimed, the phrase “treating a patient” encompasses the treatment of a variety of conditions, such as cancer, pulmonary disease, neurological disorder, and traumatic injury, in a patient from a variety of animal species, including mammals, birds, and reptiles.
The instant specification does not limit the diseases or conditions to be treated using the fixed sample of mediastinal pleura tissue. The instant specification shows products formed from fixed mammalian mediastinal pleura (see, e.g., Figs 5A-D) and provides examples of uses for such products (p 18-19), which are the products recited in claim 8 and used in surgical treatment. The specification recites that “The mammalian pulmonary ligament, the mammalian visceral pleura, and the mammalian mediastinal pleura, as referenced in detail below and disclosed within the present application, can be harvested, fixed, and used for a number of medical applications previously unknown and not identified in the medical arts” (p 5, para 2), but does not provide guidance on what is meant or encompassed by “medical applications previously unknown and not identified in the medical arts.”
Regarding the patient, the speciation recites that “mediastinal pleura 38 tissue can be harvested from pigs, horses, cows, goats, sheep, etc. and used to treat the same species or different species, including humans. Further, pulmonary ligaments 30, visceral pleura 556 and/or mediastinal pleura 38 tissue could be harvested from one human and used to treat another human” (p 17, para 1). The specification does not disclose other mammalian species from which the mediastinal pleura tissue is harvested, or other species to be treated with said tissue.
As such, the instant specification does not provide a sufficient representative sampling of the diseases or conditions to be treated with the fixed mediastinal pleura tissue, the mammalian species from which the tissue is harvested, or the species that can be treated with said tissue, which are encompassed in claim 15.
The prior art is unpredictable. Kassab (WO 2013/120082 A1) teaches that fixed sample of pulmonary tissue can be processed into medical articles, including a cover for stents, a patch, biological skin substitute, suture reinforcement, bladder and urethra tissue replacement, and muscle replacement (p 8, para 4; p 25). Kassab also suggests, but does not exemplify or reduce to practice, a method of treating a patient using a fixed sample of mammalian tissue. However, the prior art does not teach the use of a fixed tissue sample for non-surgical treatment, such as the treatment or neurological or psychiatric disorders or viral infections. Furthermore, the prior art does not teach cross-species use of tissue for treatment, aside from established models such as the use of porcine tissue for human patients (e.g., Ekser 2012, as discussed above). The prior art does not teach, for example, the use of human tissue to treat an avian or piscine patient. Therefore, the prior art cannot be relied upon for making up for the deficit of the instant specification with regard to a sufficient representative number of species of diseases or conditions, species of mammals from which the mediastinal pleura tissue is harvested, or species of patients to be treated with said tissue, to be used in the method of claim 15.
Accordingly, neither the specification nor the prior art establishes that the fixed mammalian mediastinal tissue can be used to treat a broad species of conditions or diseases in a broad species of patients, as encompassed in claim 16. Therefore, the skilled artisan would not have reasonably concluded at the time of the invention that the applicant was in possession of the invention as claimed.
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.
Claim(s) 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mariassy (Experimental Lung Research, 1983, 4(4): 293-314), as evidenced by The Goofy Anatomist (Chapter 3: Pleurae. Retrieved from the Internet 2018) and Encyclopaedia Britannica (2010, Heart in situ).
Claim Interpretation: The method of claim 1 comprises three distinct steps (acquiring a tissue in line 2; selecting a sample in line 3; and fixing the sample in line 4). Claim 1, as written, does not limit the order in which these three steps are performed. Therefore, claim 1 is interpreted as a method of processing a tissue comprising the three steps as recited, wherein the steps may be performed in any order.
As discussed above, the limitation in claim 5 is interpreted as “a sample of mediastinal pleura tissue from a section of the parietal pleura tissue that extends along a pericardium to a diaphragm of the mammal” (lines 2-4).
Mariassy discloses a method of processing parietal tissue from sheep for microscopy (Abstract). Mariassy discloses euthanizing sheep (claims 2-3), then removing the lungs (acquiring a tissue, claim 1) and fixing the lungs by tracheal infusion using Karnosky’s fixative (p 294, para 1). The parietal pleura was fixed by immersion (p 294, para 1) (claim 1). Following overnight fixation, the parietal pleura was taken from the mediastinal regions (p 294, para 2) (selecting a sample of mediastinal pleura tissue, claim 1). The Goofy Anatomist shows that the mediastinal pleura lines the medial aspect of the lung, and is thus located between the right and left lungs (p 5, para 2) (claim 4). Encyclopaedia Britannica shows that the mediastinal pleura extends along a pericardium to a diaphragm (claim 5).
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.
Claim(s) 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Kassab (WO 2013/120082 A1), in view of Mariassy (Experimental Lung Research, 1983, 4(4): 293-314), as evidenced by as evidenced by The Goofy Anatomist (Chapter 3: Pleurae. Retrieved from the Internet 2018), Encyclopaedia Britannica (2010, Heart in situ), and Kenney (Diagnostic Pathology, 2007, 2:21).
The teachings of Mariassy are set forth above.
Kassab teaches a method for harvesting and fixing mammalian visceral pleura for use in medical applications (p 14, Detailed Description, para 2 – p 15, para 1).
Regarding claim 1: Kassab teaches harvesting the visceral pleura from a mammal, then fixing the dissected tissue in a fixative (p 22, para 1).
Kassab does not teach a method of processing a tissue, wherein the tissue is mediastinal pleura from the parietal pleura.
Kassab teaches that it is advantageous to identify and process thin scaffold biological tissue that consists of largely elastin and some collagen fibers, since elastin is not as prone to fixation as collagen, and thus fixation of tissue with elastin largely maintains its elasticity and biological mechanical activity (p 15, para 2).
Mariassy teaches that the mediastinal parietal pleura comprises a fibroelastic meshwork with massive three-dimensional network of elastic fibers (p 299, Table 1, Row 5).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Kassab by using mediastinal parietal pleural tissue. One of ordinary skill in the art would have been motivated to make this modification because Kassab teaches that an ideal tissue for use in medical applications comprises elastin (p 15, para 2), and Mariassy teaches that the mediastinal pleura comprises a fibroelastic meshwork with massive three-dimensional network of elastic fibers (p 299, Table 1, Row 5). One of ordinary skill in the art would have had a reasonable expectation of making this modification because Mariassy teaches that mediastinal parietal tissue can be processed and fixed.
Furthermore, Kassab teaches that the visceral pleura becomes continuous with the parietal pleura that covers the diaphragm, chest wall and mediastinum (p 15, para 3). Given the teachings of Kassab, there was a reasonable expectation that visceral pleura and mediastinal parietal pleura would work equivalently as a fixed tissue sample. Therefore, it would have been prima facie obvious for someone of ordinary skill in the art before the effective filing date of the claimed invention to have substituted visceral pleura tissue with mediastinal parietal pleura tissue with predictable results. Substitution of one element for another known in the field, wherein the result of the substitution would have been predictable, is considered to be obvious. See KSR International Co. v Teleflex Inc 82 USPQ2d 1385 (US 2007) at page 1395.
The combination of prior art cited above in all rejections under 35 U.S.C. 103 satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. ___, 82 USPQ2d 1385 (2007): "Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. In the present situation, rationales B and G are applicable, as set forth in the rejections above. The cited prior art meets the criteria set forth in both Graham and KSR. Therefore, Kassab, in view of Mariassy, renders obvious claim 1.
Regarding claims 2-3: Kassab teaches acquiring tissue from a deceased mammal, including a pig, horse, cow, goat, sheep, and human (p 1, para 5; p 24, para 2).
Regarding claim 4: The Goofy Anatomist shows that the mediastinal pleura lines the medial aspect of the lung, and is thus located between the right and left lungs (p 5, para 2).
Regarding claim 5: Encyclopaedia Britannica shows that the mediastinal pleura extends along a pericardium to a diaphragm.
Regarding claim 6: Kassab teaches cleaning the desired tissue by removing fat and muscle covering the tissue (p 22, para 1).
Regarding claim 7: Kassab teaches positioning the tissue sample upon a mount having known dimensions (p 22, para 1).
Regarding claim 8: Kassab teaches configuring the processed tissue into products, wherein the products include stent covers and tendon replacements, among others (p 24, para 5 – p 26, para 6).
Regarding claim 9: Kassab teaches that the product comprises a first surface and a second surface (e.g., Fig. 5A-D). Kenney shows that the parietal pleura comprises elastin fibers and are lined with mesothelial cells (Abstract).
Regarding claim 10: Kassab teaches a product comprising a frame configured to retain a mammalian tissue, such that when the product is positioned within a mammalian lumen, fluid native to the mammalian lumen passes through a lumen defined within the product (p 10, para 2).
Regarding claims 11-12: Kassab teaches a product comprising a valve, which has a bileaflet or trileaflet configuration (p 25, para b).
Regarding claim 13: Kassab teaches an embodiment of the invention, wherein the fixed sample comprises tissue having stretchability and durability properties to allow the fixed sample to move relative to the fluid flow through the lumen defined within the tissue product (p 6, para 2).
Regarding claim 14: Kassab teaches an embodiment of the tissue processing method, wherein the method comprises the step of decellularizing at least a portion of the sample of pulmonary region tissue prior to performing the fixing step (p 8, para 3).
Regarding claim 15: Kassab teaches treating a patient using the product comprising the fixed tissue sample (p 8, para 4; p 25).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Risa Takenaka whose telephone number is (571)272-0149. The examiner can normally be reached M-F, 12-7 EST.
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/RISA TAKENAKA/Examiner, Art Unit 1632
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632