DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
Claims 1, 3-8, 10-21, and 23-25 are pending in the application. Claims 2, 9, and 22 have been canceled. Claims 1 and 10 have been amended.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3-5, 7, 8, 19, 20, 24, and 25 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tarrant et al. (US 2007/0162121 A1) (“Tarrant”) in view of Mizuno et al. (US 2003/0040113 A1) (“Mizuno”), Murray et al. (US 2004/0059416 A1) (“Murray”), and Miyata et al. (US 4,592,864) (“Miyata”).
Regarding claims 1 and 3, Tarrant discloses (Figures 6A-8D) a tissue healing device configured to repair a ligament or a tendon (paragraph 0058), comprising: a. a hydrophilic scaffold (protective sleeve/support matrix, paragraphs 0093-0094), comprising: one or more bioabsorbable polymers (polyglycolic acid, paragraph 0094); and Type I collagen (paragraph 0094), wherein the hydrophilic scaffold is free of thrombin and hyaluronic acid (there is no disclosure of thrombin or hyaluronic acid in the scaffold), wherein the hydrophilic scaffold is in the form of a sheet configured to be rolled entirely around the ligament or tendon such that the integrity and structure of the ligament or tendon is maintained (paragraph 0035), wherein the hydrophilic scaffold is capable of absorbing blood (Tarrant discloses a sponge structure that is biocompatible, biodegradable, and hydrophilic; paragraph 0094) having white blood cells and platelet rich plasma, and wherein the hydrophilic scaffold is capable of encouraging the migration of appropriate healing cells to form scar and new tissue and capable of facilitating healing and regeneration (Tarrant discloses that fibroblasts are incorporated, adhered to, embedded, or seeded into the support matrix, paragraphs 0063 and 0099); and b. at least one suture configured to attach to the hydrophilic scaffold to secure the hydrophilic scaffold in position around the ligament or tendon (Tarrant discloses that the scaffold is directly attached to the uninjured portion of the ligament or tendon via surgical stitches, paragraphs 0140 and 142).
However, Tarrant fails to disclose that the at least one suture is bioabsorbable. Tarrant also fails to explicitly disclose that the Type I collagen comprises heterotrimeric collagen, wherein the Type I collagen is at a concentration of at least 15 mg/mL to less than or equal to 50 mg/mL, and one or more bioabsorbable polymers. Tarrant also fails to disclose the scaffold is derived from a collagen solution at 280 mOs/kg to 360 mOs/kg.
Mizuno teaches that Type I collagen comprising heterotrimeric collagen is predominantly found in bone, skin (in sheet-like structures), and tendon (in rope-like structures; paragraph 0062). Mizuno teaches that the concentration of collagen in a scaffold is a result effective variable. Varying the concentration of collagen adjusts the porosity of the scaffold (paragraph 0099). Increasing the pore size of the scaffold improves cell infiltration into the scaffold (paragraph 0100).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the Type I collagen disclosed by Tarrant to comprise heterotrimeric collagen, as taught by Mizuno. The tissue healing device serves to repair a ligament or tendon, and heterotrimeric collagen is found in rope-like structures (tendons and ligaments) in the body (Mizuno, paragraph 0062). Further, “it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice” In re Leshin, 125 USPQ 416.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the Type I collagen to be at a concentration of at least 15 mg/mL to less than or equal to 50 mg/mL as a matter of routine optimization, since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Mizuno teaches that collagen concentration is a result effective variable in that varying the concentration of collagen in a scaffold adjusts the porosity of the scaffold. Increased pore size of the scaffold improves cell infiltration into the scaffold (paragraphs 0099-0100). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the scaffold disclosed by Tarrant to have the claimed concentration of Type I collagen.
In the same field of endeavor, Murray teaches that those skilled in the art will recognize that many attachment methods and devices may be appropriate for attaching a repair scaffold, but not limited to, tacks, sutures, biological adhesives, anchors, screws, and staples. Preferably, the attachment devices are bioabsorbable with a structural life longer than that of the scaffold to ensure proper placement of the scaffold (paragraph 0117).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the at least one suture to be bioabsorbable, to ensure proper placement of the scaffold (Murray, paragraph 0117).
Miyata teaches an aqueous collagen solution having a pH of about 6.5 to about 8.0 and an osmolality in the range from about 250-320 mOs/kg (Column 2, lines 40-43). Miyata teaches that the pH and osmolality of the scaffold are adjusted so that the solution has properties that are close to biological conditions (Column 2, lines 9-15 and lines 51-54).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the scaffold taught by Tarrant in view of Mizuno and Murray above to be derived from a collagen solution at 280 mOs/kg to 360 mOs/kg, as taught by Miyata, since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, Miyata teaches that this range will provide a collagen solution that has properties that are close to biological conditions (Miyata, Column 2, lines 9-15 and lines 51-54).
Regarding claim 4, Tarrant as modified by Mizuno, Murray, and Miyata teaches one or more growth factors configured to be disposed within or on the scaffold (Tarrant, paragraphs 0094 and 0162).
Regarding claim 5, Tarrant as modified by Mizuno, Murray, and Miyata teaches one or more cellular components configured to be disposed within or on the scaffold (Tarrant, paragraphs 0099-0102).
Regarding claim 7, Tarrant as modified by Mizuno, Murray, and Miyata teaches stem cells configured to be disposed within or on the scaffold (Tarrant, paragraphs 0063 and 0099).
Regarding claim 8, Tarrant as modified by Mizuno, Murray, and Miyata teaches fibroblasts configured to be disposed within or on the scaffold (Tarrant, paragraphs 0063 and 0099).
Regarding claim 19, Tarrant as modified by Mizuno, Murray, and Miyata teaches the one or more bioabsorbable polymers include a polylactic acid base (Tarrant, paragraph 0094).
Regarding claim 20, the at least one suture taught by Tarrant as modified by Mizuno, Murray, and Miyata is capable of being tied using maximum tension to secure the scaffold around the ligament (Tarrant, paragraphs 0140-0143, 0150-0151, 0155).
Regarding claim 24, Tarrant as modified by Mizuno, Murray, and Miyata above teaches the invention substantially as claimed. However, the combined teaching above fails to explicitly teach that the hydrophilic scaffold is free of crosslinking agent.
Tarrant teaches that the hydrophilic scaffold is typically porous, sponge, honeycomb, lattice or scaffold structure made of collagenous or collagen containing material. The support matrix is preferably biocompatible, biodegradable, hydrophilic, non-reactive, has a neutral charge and is able to have or has a defined structure. The support matrix is fabricated from materials such as Type I collagen, Type II collagen, Type IV collagen, gelatin, agarose, or derivatized or cross-linked collagen, collagen containing proteoglycans, glycosaminoglycans or glycoproteins, polymers of aromatic organic acids, fibronectin, laminin, bioactive peptide growth factors, cytokines, elastin, fibrin, synthetic polymeric fiber made of poly-acids such as polylactic, polyglycolic or polyamino acids, polycaprolactones, polyamino acids, polypeptide gel, copolymers thereof, mixtures thereof and any and all combinations thereof.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the hydrophilic scaffold taught by Tarrant in view of Mizuno, Murray, and Miyata to be free of crosslinking agent, since “it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice” In re Leshin, 125 USPQ 416.
Regarding claim 25, Tarrant as modified by Mizuno, Murray, and Miyata above teaches the invention substantially as claimed. The combined teaching teaches that the hydrophilic scaffold has a neutral charge (Tarrant, paragraph 0094). However, the combined teaching above fails to explicitly teach a neutralizing agent.
Murray further teaches that sodium hydroxide or hydrochloric acid are neutralizing agents that are added to neutralize a collagen scaffold (paragraph 0102).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the scaffold taught by Tarrant in view of Mizuno, Murray, and Miyata to include a hydroxide or hydrochloric acid neutralizing agent, as further taught by Murray to achieve the disclosed neutral charge of the hydrophilic scaffold (Murray, paragraph 0102).
Claim 6 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tarrant et al. (US 2007/0162121 A1) (“Tarrant”) in view of Mizuno et al. (US 2003/0040113 A1) (“Mizuno”), Murray et al. (US 2004/0059416 A1) (“Murray”), and Miyata et al. (US 4,592,864) (“Miyata”) as applied to claim 1 above, and further in view of Connelly et al. (US 2004/0005297 A1) (“Connelly”).
Regarding claim 6, Tarrant in view of Mizuno, Murray, and Miyata teaches the invention substantially as claimed. However, the combined teaching fails to teach one or more cell surface receptors configured to be disposed within or on the scaffold.
Connelly teaches (Figure 1) a biological scaffold (10) comprising collagen (paragraph 0045). Connelly teaches that cell surface receptors are synergistic in regulating gene transcription, cellular differentiation and function (paragraph 0045).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the tissue healing device taught by Tarrant in view of Mizuno, Murray, and Miyata to comprise one or more cell surface receptors configured to be disposed within or on the scaffold to regulate gene transcription, cellular differentiation and function (Connelly, paragraph 0045).
Claims 10-13 and 15-18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tarrant et al. (US 2007/0162121 A‘) (“Tarrant”) in view of Mizuno et al. (US 2003/0040113 A1) (“Mizuno”), Murray et al. (US 2004/0059416 A1) (“Murray”), Stone (US 5,702,422), and Miyata et al. (US 4,592,864) (“Miyata”).
Regarding claims 10 and 11, Tarrant discloses a tissue healing device configured to repair a ligament or a tendon, comprising: a. a hydrophilic scaffold (protective sleeve/support matrix, paragraphs 0093-0094), comprising: one or more bioabsorbable polymers (polyglycolic acid, paragraph 0094); and Type I collagen (paragraph 0094), wherein the hydrophilic scaffold is free of thrombin and hyaluronic acid (there is no disclosure of thrombin or hyaluronic acid in the scaffold), wherein the hydrophilic scaffold is in the form of a sheet and configured to be rolled into a tube that surrounds the ligament or tendon (paragraph 0045) such that the integrity and structure of the ligament or the tendon is maintained (paragraph 0035), wherein the hydrophilic scaffold is capable of absorbing platelet rich plasma and white blood cells (Tarrant discloses a sponge structure that is biocompatible, biodegradable, and hydrophilic, thus capable of absorbing PRP and white blood cells; paragraph 0094), wherein the scaffold is resistant to degradation by synovial fluid around the ligament or tendon (Tarrant discloses that the scaffold repairs a ligament/tendon in a joint, paragraph 0162), and wherein the scaffold encourages the migration of appropriate healing cells to form scar and new tissue and facilitates healing and regeneration (Tarrant discloses that fibroblasts are incorporated, adhered to, embedded, or seeded into the support matrix, paragraphs 0063 and 0099); and b. at least one suture configured to secure the scaffold in position relative to the ligament or the tendon (Tarrant discloses that the scaffold is directly attached to the uninjured portion of the ligament or tendon via surgical stitches, paragraphs 0140 and 142).
Tarrant discloses that the scaffold is attached to the injured portion of the ligament or tendon or to the bone or muscle using surgical stitches, staples, or other means of attachment (paragraph 0140). However, Tarrant fails to disclose at least one fixation device configured to lie adjacent the first bone, the at least one fixation device having an opening through which the least one suture extends, such that the hydrophilic scaffold is connectable to the ligament or tendon and the first bone to the first bone via the at least one fixation device. Tarrant also fails to disclose that the at least one suture is bioabsorbable. Tarrant further fails to explicitly disclose that the Type I collagen comprises heterotrimeric collagen, wherein the Type I collagen is at a concentration of at least 15 mg/mL to less than or equal to 50 mg/mL. Tarrant also fails to disclose platelet rich plasma configured to be absorbed into the scaffold. Tarrant fails to disclose that the scaffold is derived from a collagen solution at 280 mOs/kg to 360 mOs/kg.
Mizuno teaches that Type I collagen comprising heterotrimeric collagen is predominantly found in bone, skin (in sheet-like structures), and tendon (in rope-like structures; paragraph 0062). Mizuno teaches that the concentration of collagen in a scaffold is a result effective variable. Varying the concentration of collagen adjusts the porosity of the scaffold (paragraph 0099). Increasing the pore size of the scaffold improves cell infiltration into the scaffold (paragraph 0100).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the Type I collagen disclosed by Tarrant to comprise heterotrimeric collagen, as taught by Mizuno. The tissue healing device serves to repair a ligament or tendon, and heterotrimeric collagen is found in rope-like structures (tendons and ligaments) in the body (Mizuno, paragraph 0062). Further, “it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice” In re Leshin, 125 USPQ 416.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the Type I collagen to be at a concentration of at least 15 mg/mL to less than or equal to 50 mg/mL as a matter of routine optimization, since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Mizuno teaches that collagen concentration is a result effective variable in that varying the concentration of collagen in a scaffold adjusts the porosity of the scaffold. Increased pore size of the scaffold improves cell infiltration into the scaffold (paragraphs 0099-0100). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the scaffold disclosed by Tarrant to have the claimed concentration of Type I collagen.
In the same field of endeavor, Murray teaches that those skilled in the art will recognize that many attachment methods and devices may be appropriate for attaching a repair scaffold, but not limited to, tacks, sutures, biological adhesives, anchors, screws, and staples. Preferably, the attachment devices are bioabsorbable with a structural life longer than that of the scaffold to ensure proper placement of the scaffold (paragraph 0117). Murray further teaches that a scaffold formed of Type I collagen can have platelet rich plasma incorporated (paragraphs 0102-0104) to enhance the adhesive properties of the collagen scaffold (paragraph 0348).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the at least one suture to be bioabsorbable, to ensure proper placement of the scaffold (Murray, paragraph 0117). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the scaffold to have platelet rich plasma absorbed therein to enhance the adhesive properties of the collagen scaffold (Murray, paragraph 0348).
In the same field of endeavor, Stone teaches (Figures 1-3) a means of attachment for connecting a suture (40) to bone (20). Stone teaches at least one fixation device (45) configured to lie adjacent the first bone (20), the at least one fixation device having an opening through which the least one suture extends (Figure 3), such that the suture is connectable to the ligament or tendon (16) and the first bone (20).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the tissue healing device taught by Tarrant in view of Mizuno and Murray to comprise at least one fixation device configured to lie adjacent the first bone, the at least one fixation device having an opening through which the least one suture extends, as taught by Stone, such that the hydrophilic scaffold is connectable to the ligament or tendon and the first bone via the at least one fixation device. Tarrant discloses that the scaffold is connectable to the uninjured portion of the ligament or tendon or to the bone or muscle using surgical stitches, staples, or other means of attachment (paragraph 0140). Stone teaches that a fixation device having an opening through which a suture extends is a means of attachment known in the art at the time the invention was made. Application of a known technique (coupling a suture to bone via a fixation device having an opening through which the suture extends) to a known device (the tissue healing device taught by Tarrant in view of Mizuno and Murray) to yield predictable results (attaching the scaffold to the ligament/tendon and to the first bone) would have been obvious to one having ordinary skill in the art at the time the invention was made.
Miyata teaches an aqueous collagen solution having a pH of about 6.5 to about 8.0 and an osmolality in the range from about 250-320 mOs/kg (Column 2, lines 40-43). Miyata teaches that the pH and osmolality of the scaffold are adjusted so that the solution has properties that are close to biological conditions (Column 2, lines 9-15 and lines 51-54).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the scaffold taught by Tarrant in view of Mizuno, Murray, and Stone above to be derived from a collagen solution at 280 mOs/kg to 360 mOs/kg, as taught by Miyata, since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, Miyata teaches that this range will provide a collagen solution that has properties that are close to biological conditions (Miyata, Column 2, lines 9-15 and lines 51-54).
Regarding claim 12, Tarrant as modified by Mizuno, Murray, Stone, and Miyata teaches one or more growth factors configured to be disposed within or on the scaffold (Tarrant, paragraphs 0094 and 0162).
Regarding claim 13, Tarrant as modified by Mizuno, Murray, Stone, and Miyata teaches one or more cellular components configured to be disposed within or on the scaffold (Tarrant, paragraphs 0099-0102).
Regarding claim 15, Tarrant as modified by Mizuno, Murray, Stone, and Miyata teaches stem cells configured to be disposed within or on the scaffold (Tarrant, paragraph 0099).
Regarding claim 16, Tarrant as modified by Mizuno, Murray, Stone, and Miyata teaches fibroblasts configured to be disposed within or on the scaffold (Tarrant, paragraphs 0063 and 0099).
Regarding claim 17, Tarrant as modified by Mizuno, Murray, Stone, and Miyata teaches the one or more bioabsorbable polymers include a polylactic acid base (Tarrant, paragraph 0094).
Regarding claim 18, Tarrant as modified by Mizuno, Murray, Stone, and Miyata teaches the at least one suture is capable of being tied using maximum manual tension to secure the scaffold around the ligament (Tarrant, paragraphs 0140-0143, 0150-0151, 0155).
Claim 14 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tarrant et al. (US 2007/0162121 A‘) (“Tarrant”) in view of Mizuno et al. (US 2003/0040113 A1) (“Mizuno”), Murray et al. (US 2004/0059416 A1) (“Murray”), Stone (US 5,702,422), and Miyata et al. (US 4,592,864) (“Miyata”) as applied to claim 10 above, and further in view of Connelly et al. (US 2004/0005297 A1) (“Connelly”).
Regarding claim 14, Tarrant in view of Mizuno, Murray, Stone, and Miyata teaches the invention substantially as claimed. However, the combined teaching fails to teach one or more cell surface receptors configured to be disposed within or on the scaffold.
Connelly teaches (Figure 1) a biological scaffold (10) comprising collagen (paragraph 0045). Connelly teaches that cell surface receptors are synergistic in regulating gene transcription, cellular differentiation and function (paragraph 0045).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the tissue healing device taught by Tarrant in view of Mizuno, Murray, Stone, and Miyata to comprise one or more cell surface receptors configured to be disposed within or on the scaffold to regulate gene transcription, cellular differentiation and function (Connelly, paragraph 0045).
Claim 21 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tarrant et al. (US 2007/0162121 A1) (“Tarrant”) in view of Mizuno et al. (US 2003/0040113 A1) (“Mizuno”), Murray et al. (US 2004/0059416 A1) (“Murray”), and Miyata et al. (US 4,592,864) (“Miyata”) as applied to claim 1 above, and further in view of Minamigawa et al. (US 2003/0194805 A1) (“Minamigawa”).
Regarding claim 21, the combined teaching of Tarrant as modified by Mizuno, Murray, and Miyata teaches the invention substantially as claimed. However, the combined teaching fails to teach the scaffold is derived from a solution comprising a minimum viscosity of 1,000 centipoise.
Minamigawa teaches that collagen concentration and viscosity of a collagen solution influences its shape and structure. Minamigawa teaches that viscosity being too high or too low can have adverse effects, such as the collagen being difficult to handle. Minamigawa teaches a collagen derived from a solution comprising a viscosity of 1,000 centipoise (paragraph 0073).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the scaffold to be derived from a solution comprising a minimum viscosity of 1,000 centipoise, as taught by Minamigawa. This modification would provide a scaffold with a viscosity that is not too high or too low, both of which can have adverse effects, such as the collagen being difficult to handle (Minamigawa, paragraph 0073).
Claim 23 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tarrant et al. (US 2007/0162121 A1) (“Tarrant”) in view of Mizuno et al. (US 2003/0040113 A1) (“Mizuno”), Murray et al. (US 2004/0059416 A1) (“Murray”), and Miyata et al. (US 4,592,864) (“Miyata”) as applied to claim 1 above, and further in view of Ashkar et al. (US 6,165,487) (“Ashkar”).
Regarding claim 23, the combined teaching of Tarrant as modified by Mizuno, Murray, and Miyata teaches the invention substantially as claimed. However, the combined teaching fails to explicitly teach that the hydrophilic scaffold further comprises hydroxyproline.
Ashkar teaches that Type I collagen comprises hydroxyproline (Column 6, lines 8-13).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the hydrophilic scaffold comprises hydroxyproline. Tarrant as modified by Mizuno, Murray, and Miyata teaches that the scaffold comprises Type I collagen. Ashkar teaches that hydroxyproline is a natural component of Type I collagen (Ashkar, Column 6, lines 8-13).
Response to Arguments
Applicant’s arguments with respect to claims 1, 3-8, 10-21, and 23-25 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The Miyata reference is newly cited to teach a collagen solution at 280 mOs/kg to 360 mOs/kg and does not teach hyaluronic acid like the previously cited Tsunenaga reference.
Applicant's arguments filed 2/3/26 regarding the claimed range of greater than 5 mg/mL to less than or equal to 50 mg/mL being critical on page 9 of the response have been fully considered but they are not persuasive.
The Applicant has argued that paragraph 0045 of the Specification establishes criticality of the claimed range. The Examiner respectfully disagrees. First, paragraph 0045 recites a concentration of 1-50 mg/mL, which includes values outside the claimed range. Therefore, the claimed range is not critical. Further, paragraph 0045 discloses the claimed range is “useful for producing viscosity levels that are desirable for the methods of the invention.” While this range is described as “useful”, there is no disclosure that it is critical.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771