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 IV, claims 20-25, and the election of the species encompassing claims 20, 23, 24, 26 in the reply filed on 3/31/2025 is acknowledged. The traversal is on the ground(s) that the examiner has not shown the burden on the examiner to search all of the inventions. Applicant is reminded of the extensive literature search which is NOT co-extensive. This is not found persuasive because they differ in structure and function.
Therefore, claims 1-14, 21, 22, 25 are withdrawn from further consideration by the Examiner as being drawn to non-elected inventions.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claims 20, 23, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/136786.
WO teaches a solution or hydrogel obtained by powdering extracellular matrix (ECM) obtained by decellularizing a pig kidney (paragraph 165) and claim 4. In addition, WO indicates that the solution or hydrogel increases metabolic activity in kidney pig stem cells (see paragraphs 22, 90-95, 118, 23, 24) can be applied to the repair or regeneration of damaged tissue and can be used to deliver therapeutic substances for treating acute kidney injury.
Furthermore, the document indicates that the ECM can be obtained from the liver, the spleen, the lungs, the pancreas, the intestines blood vessels, etc., the ECM is obtained as a result of being subjected to washing, a trypsin treatment, a surfactant (tween 20 and sodium deoxycholate) treatment after tissue slicing and the hydrogel is obtained by being subjected to lyophilization and pulverization steps and the final concentration of the hydrogel is 6 mg/m.
A comparison of the invention as in the claims 20, 23, 24 and 26 of the present application reveals that the extracellular matrix obtained by decellularizing organs described in the references, and the agent described in the documents, which increase metabolic activity in kidney stem cells (KSCs) is delivered to the kidney, and can be used in the repair or regeneration of damaged tissue corresponds to the “kidney regeneration accelerator”.
Applicant argues that allegedly WO does not provide any specific examples demonstrating that components obtained by decellularizing an organ of a mammal (dECM} promote kidney regeneration in vivo, nor does it specifically examine the characteristics of dECM that are suitable for kidney regeneration.
There is NO requirement for any specific examples to be in a reference to show non-obviousness. Disclosure can be from any part of the reference which is NOT limited to only the examples.
Applicant argues that allegedly the Examples in the specification of this application, demonstrate that regeneration of kidnev tissue occurs in vivo in pigs and rats using L-dECM (liver-derived) at a concentration of 8 mg/mL, and K-dECM (kidney-derived) at concentrations of 8 mg/mL and 16 mg/mL
If applicant is inferring unexpected results, it is not seen how these results are unexpected or what they are.
By adjusting the concentration {viscosity} of dECM in a specific range, it is possible to achieve the effect of remaining in the defective area of the kidney and also promoting cellular infiltration, according to applicant. See for example, paragraphs [0067], [0078], [0080], and [0083] of the present specification.
Even a person skilled in the art who had read WO would not have been able to conclude that dECM promotes kidney regeneration in vivo, and it would have been difficult to arrive at the concentration of dECM that could promote kidney regeneration in vivo, according to applicant.
Note that “promotion” reads on WO inherently since the same composition as claimed is being used to “promote” the kidney regeneration in vivo.
MPEP 2144.05, subsection II.
II. ROUTINE OPTIMIZATION
A. Optimization Within Prior Art Conditions or Through Routine Experimentation
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
B. There Must Be an Articulated Rationale Supporting the Rejection
In order to properly support a rejection on the basis that an invention is the result of "routine optimization", the examiner must make findings of relevant facts, and present the underpinning reasoning in sufficient detail. The articulated rationale must include an explanation of why it would have been routine optimization to arrive at the claimed invention and why a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017). See also In re Van Os, 844 F.3d 1359,1361,121 USPQ2d 1209, 1211 (Fed. Cir. 2017 ("Absent some articulated rationale, a finding that a combination of prior art would have been ‘common sense’ or ‘intuitive’ is no different than merely stating the combination ‘would have been obvious.’"); Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1362, 119 USPQ2d 1822 (Fed. Cir. 2016) ("[R]eferences to ‘common sense’ … cannot be used as a wholesale substitute for reasoned analysis and evidentiary support … .").
The Supreme Court has clarified that an "obvious to try" line of reasoning may properly support an obviousness rejection. In In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977), the CCPA held that a particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation, because "obvious to try" is not a valid rationale for an obviousness finding. However, in KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions. 550 U.S. at 421 ("The same constricted analysis led the Court of Appeals to conclude, in error, that a patent claim cannot be proved obvious merely by showing that the combination of elements was ‘[o]bvious to try.’ ... When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103."). Thus, after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.
Clearly viscosity and concentration are result effective variables. The viscosity and concentration are clearly important variables when adjusted to provide the proper viscosity and concentration for the smooth operation of the pharmaceutical composition.
Applicant amended claim 20 to read, “wherein the pharmaceutical composition has a viscosity in a range of 350 mPa-s to 1000 mPa-s, and wherein a concentration of the component is in a range of 16 mg/mL to 25 mg/mL relative to the pharmaceutical composition”. Applicant argued that allegedly as shown in Figures 8 and 9 and in the specification at paragraphs 81 and 84 that in obtaining a viscosity and concentration in these ranges dECM promotes kidney regeneration in vivo.
Note that “promotion” reads on WO inherently since the same composition as claimed is being used to “promote” the kidney regeneration in vivo.
Even applicant’s own specification and arguments teach away from using 8 mg/ml K-dECM versus using 16 mg/ml K-dECM. Applicant’s specification only supports a purported critical viscosity of 16 mg/ml K-dECM and a concentration of 350 mPa-s NOT across the claimed ranges. These are merely end points and NOT ranges. The Figures do not help to support anything. If applicant is inferring unexpected results, it is not seen how these results are unexpected or what they are.
It is further noted that applicant never defines “dECM” anywhere in the specification.
Clearly viscosity and concentration are result effective variables. The viscosity and concentration are clearly important variables when adjusted to provide the proper viscosity and concentration for the smooth operation of the pharmaceutical composition.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL V MELLER whose telephone number is (571)272-0967. The examiner can normally be reached M-F 9 am-5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MICHAEL V. MELLER
Primary Examiner
Art Unit 1655
/MICHAEL V MELLER/Primary Examiner, Art Unit 1655
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