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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/19/2026 has been entered.
Claims status
Claims 21-23 is/are new. Claims 1, 2, 4-10, 12-14, 16-18, 20-23 is/are currently pending and is/are under examination.
Duplicate Claim Warning – Updated in accordance with claim amendments
Applicant is advised that should claim 6 be found allowable, claims 10, 12-13 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
In the instant case, Claim 6 is “A method for substituting a subcutaneous adipose tissue comprising: administering to a human patient the mature adipocyte-containing composition according to claim 1”.
Claims 10, 12, 13 recite methods similar to claim 6 with the only difference being in claims 10, 12, 13 the mature adipocyte-containing compositions are provided by claims 2, 4 and 5.
The mature adipocyte-containing compositions provided by claims 1, 2, 4 and 5 are identical. Claim 1 sets forth the method steps that derive the mature adipocyte-containing composition from adipose tissue. Claim 2 provides a step that occurs before the steps recited in claim 1 such that the mature adipocyte-containing composition derived from the method of claim 2 is the same as the method of claim 1. Claims 4 and 5 do not recite additional method step but identify factors present in the conditioned media of claim 1, thus the mature adipocyte composition of claim 1 inherently comprises the factors recited in claims 4 and 5 such that the mature adipocyte-containing composition derived from the method of claim 4 and 5 are the same as the method of claim 1.
Thus, each of claims 6, 10, 12, 13 are directed to identical method that comprises administering identical compositions for identical intended purpose recited in their preambles.
Applicant is advised that should claim 7 be found allowable, claims 14, 16, 17 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
In the instant case, Claim 7 is “The method for performing augmentation mammaplasty, breast reconstruction surgery, or tissue recess reconstruction surgery”, comprising administering composition of claim 1.
Claims 14, 16, 17 recite methods similar to claim 7 with the only difference being in claims 14, 16, 17 the mature adipocyte-containing compositions are provided by claims 2, 4 and 5.
As noted above, the mature adipocyte-containing compositions provided by claims 1, 2, 4 and 5 are identical. Thus, each of claims 7, 14, 16, 17 are directed to identical method that comprises administering identical compositions for identical intended purpose recited in their preambles.
Applicant is advised that should claims 8 be found allowable, claims 18, 20 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
In the instant case, Claim 8 is “A method for producing a revascularization promoting agent comprising: formulating the mature adipocyte-containing composition according to claim 1 with a pharmaceutically acceptable carrier”.
Claims 18 and 20 recite methods similar to claim 8 with the only difference being in claims 18 and 20 the mature adipocyte-containing compositions are provided by claims 2, and 4.
As detailed above, the mature adipocyte-containing compositions provided by claims 1, 2, and 4 are identical such that claims 8, 18 and 20 are directed to identical methods.
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.
Rejection of Claims 6, 7, 10, 12-14, 16, 17 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 claim amendments.
Claims 1, 2, 4-10, 12-14, 16-18, 20-23 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.
Claim 1 recites “the microfat being obtained without treating with an enzyme”. Claim does not recite what element is not being treated with an enzyme in the obtention of the said microfat element? For the purpose of compact prosecution, the claim(s) 1 is/are interpreted as “the microfat being obtained without treating the adipose tissue or the shredded adipose tissue with an enzyme”.
Claim 2, 4-10, 12-14, 16-18, 20-23 is/are rejected due their dependence on claim 1 because they do not clarify the 112b issue noted with claim 1.
Claim Interpretation
Claims 4 and 5 recite elements (and their ratio-metric relations) that are inherently present in the conditioned media of a cultured mature adipocyte produced by the method of claim 2. Therefore, prior art that anticipates or renders obvious the methods of claim 2 also meet the inherent limitation of claims 4 and 5.
Claims 8, 18, 20 recite methods comprising formulating the mature adipocyte compositions of claim 1, 2 and 4 respectively with a pharmaceutically acceptable carriers. The preambles for these claim each recite that the intended use of the formulation produced by the methods is “for producing a revascularization agent”. According to MPEP 2111.02, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction”. The intended use recited in the preamble of claims 8, 18-20 do not impart any structure to the claimed method steps or the product produced. Therefore, an art that anticipates or renders obvious a method wherein the mature adipocyte compositions of claim 1, 2 and 4 is formulated with a carrier that is pharmaceutically acceptable meets the intended use recited in the claim preamble.
Claims 9 recite elements that are inherently present in the conditioned media of a cultured mature adipocyte produced by the method of claim 1. Therefore, prior art that anticipates or renders obvious the methods of claim 8 also meet the inherent limitation of claim 9.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Rejection of Claim(s) 1, 2, 4, 5, 8, 9, 18, 20 under 35 U.S.C. 103 as being unpatentable over Huber et al (Tissue Engineering: Part C, Vol. 21, Nov. 12, 2015) and Alharbi (Journal of Plastic, Reconstructive & Aesthetic Surgery (2013) 66, 1271-1278; ref of record) in view of Valk et al (Toxicology in Vitro 24 (2010) 1053–1063) as evidenced by Zhang et al (Journal of Endocrinology (2000) 164, 119–128) and Cytiva (What is fetal bovine serum (FBS)?; Nov. 10, 2025) is withdrawn in light of claim amendment.
Rejection of Claim(s) 6, 7, 10, 12, 13, 14, 16, 17 under 35 U.S.C. 103 as being unpatentable over Huber et al (Tissue Engineering: Part C, Vol. 21, Nov. 12, 2015) and Alharbi (Journal of Plastic, Reconstructive & Aesthetic Surgery (2013) 66, 1271-1278; ref of record) in view of Valk et al (Toxicology in Vitro 24 (2010) 1053–1063) as evidenced by Zhang et al (Journal of Endocrinology (2000) 164, 119–128) and Cytiva (What is fetal bovine serum (FBS)?; Nov. 10, 2025) as applied to claim 1, 2, 4, 5 above, and further in view of Yanaga et al (24th Annual Meeting of Japanese Breast Cancer society, 2016, p. 364, Abstract DP-2-63-4, Tokyo, Japan; ref of record) is withdrawn due to withdrawal of rejection of claim 1, 2, 4, 5 above.
Claim(s) 1, 2, 4, 5, 8, 9, 18, 20-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huber et al (Tissue Engineering: Part C, Vol. 21, Nov. 12, 2015; ref of record), Alharbi (Journal of Plastic, Reconstructive & Aesthetic Surgery (2013) 66, 1271-1278; ref of record) and Kakudo et al (Biochemical and Biophysical Research Communications 359 (2007) 239–244) in view of Cohen et al (Aesthetic Surgery Journal Open Forum, September 2019, pg. 1-11) and Valk et al (Toxicology in Vitro 24 (2010) 1053–1063; ref of record) as evidenced by Zhang et al (Journal of Endocrinology (2000) 164, 119–128; ref of record).
Regarding claims 1 and 2, Huber teaches a method for culturing mature adipocytes in a medium for 3 weeks (page 1238, col. 1, para 7) such that Huber’s method is a method for producing a mature adipocyte-containing composition. Huber’s method comprises washing fat suctioned from a patient and then removing a blood component (as required by claim 2; Materials and Methods: Adipocyte isolation and measurement of cell size). This is also evidenced by Zhang that Huber references as the source of their base method. Zhang explicitly evidences “Adipose tissue was promptly washed with Hank’s balanced salt solution (HBSS; Gibco-BRL Life Technology, Paisley, Strathclyde, UK), and visible blood vessels were removed” (Materials and Methods: Isolation and culture of adipocytes).
Next, Huber teaches shredding the obtained adipose tissue using an collagenase-enzyme based method and then filtering the shredded adipose tissue by passing through a 500um sieve followed by centrifugation to collect fat component floating in the supernatant layer after centrifugation (Materials and Methods: Adipocyte isolation and measurement of cell size; Zhang evidences collection of supernatant in Materials and Methods: Isolation and culture of adipocytes).
Finally, Huber cultures the fat component floating in the supernatant layer after centrifugation in various culture media for at least 3 week to obtain a mature adipocytes and their conditioned media composition (Materials and Methods: Encapsulation of mature adipocytes into collagen type I hydrogels). Although Huber does not explicitly state the use of a 5% CO2 incubator, Zhang evidences that adipocytes were cultured in 5% CO2 (page 120, col. 2, para 1). 5% CO2 inherently means 95% air which comprises at least 1-10% O2 (as required by claim 23).
Regarding enzyme-free methods as claimed, Huber does not teach an enzyme-free method wherein the shredding is done by mechanical process to obtain their composition. However, such methods were known in the art. Alharbi taught use of an enzyme free method to shred adipose tissue into micronized fats which they filtered, centrifuged and cultured same as Huber (as required by claim 22; Methods and materials: Micro-fat-harvesting technique, Washing and centrifugation of the obtained Lipoaspirate, Testing fat tissue viability and survival rate in vitro). Thus, Alharbi teaches an alternative method to obtain adipocytes for culture.
Regarding enzyme-using vs enzyme-free methods, Cohen teaches that “the enzymatic digestion of adipose tissue has been deemed by the FDA as a more than minimal manipulation of tissues, which makes it a clinical disadvantage compared with the minimally manipulative mechanical methods of isolation.” (page 2, col. 1, para 3)
Regarding the culture medium composition, Huber teaches inclusion of adipogenic and lipogenic factors in the culture medium to promote maintenance of mature adipocytes in culture which are prone to dedifferentiation (Abstract, Introduction-para 3). Huber specifically teaches inclusion of dexamethasone (400ng/ml in the culture medium; page 1238, col. 2, para 1).
Although Huber does not teach hydrocortisone, however dexamethasone and hydrocortisone are equivalents known in the art such that substituting equivalent known for the same purpose is prima facie obvious (see MPEP 2144.06). “Smith v. Hayashi, 209 USPQ 754 (Bd. of Pat. Inter. 1980) (The mere fact that phthalocyanine and selenium function as equivalent photoconductors in the claimed environment was not sufficient to establish that one would have been obvious over the other. However, there was evidence that both phthalocyanine and selenium were known photoconductors in the art of electrophotography. "This, in our view, presents strong evidence of obviousness in substituting one for the other in an electrophotographic environment as a photoconductor." 209 USPQ at 759.)”. In the instant case, an ordinary artisan recognizes that both dexamethasone and hydrocortisone were known glucocorticoids in the cell culture art and were commonly used as alternatives in cell culture media. Valk teaches optimization of cell culture medium and identifies hydrocortisone and dexamethasone as alternative glucocorticoids used in cell culture media (page 1056, col. 1, para 1; Figure 1). Therefore, in teaching dexamethasone, Huber renders its equivalent hydrocortisone prima facie obvious.
Regarding inclusion of FGF2, Huber does not teach inclusion of FGF2 in their culture medium, However, FGF2 was a known adipogenic factor. Kakudo teaches FGF2 as an adipogenic factor that promotes adipocyte formation (Abstract; Discussion, para 1). Kakudo also teaches combined effect of FGF2 and dexamethasone, the corticosteroid alternative of the claimed hydrocortisone, in promoting adipogenesis (Figure 3; Discussion, para 1). Kakudo uses FGF2 at 10ng/ml (as required by claim 21; Cell culture).
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Huber’s method for producing mature-adipocyte-containing composition to comprise an enzyme-free mechanical shredding step, as taught by Alharbi, and include FGF2, an additional adipogenic factor that functions synergistically with corticosteroids such as dexamethasone or hydrocortisone, as taught by Kakudo. An ordinary artisan would be motivated to use an enzyme-free mechanical shredding step, as taught by Alharbi, in place of the enzymatic shredding step of Huber because of teachings from Cohen regarding disadvantage of enzymatic digestion. Further, an ordinary artisan would be motivated to additionally include FGF2 in the culture medium of Huber because Huber teaches that inclusion of adipogenic factors in the culture medium promote mature adipocyte culture and Kakudo teaches that FGF2 is an adipogenic factor. An ordinary artisan would reasonably expect to use Alharbi’s enzyme-free mechanical shredding step in place of the enzymatic shredding step of Huber because both result in generation of microfats for culture and both culture the fats after shredding. Further, an ordinary artisan would reasonably expect to include FGF2 in Huber’s culture medium by adding FGF2 to Huber’s culture medium.
Regarding the specific concentration of hydrocortisone and FGF2 recited in claim 1, an ordinary artisan could identify optimal concentration of these agents using routine optimization. In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (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, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art."). In the instant case, Huber teaches inclusion of adipogenic factors, such as dexamethasone (400ng/ml in the culture medium; page 1238, col. 2, para 1). Valk identifies dexamethasone and hydrocortisone as equivalents (page 1056, col. 1, para 1; Figure 1). Kakudo uses FGF2 at 10ng/ml as an adipogenic factor (Cell culture). Thus, the prior art teaches and motivates an artisan to include hydrocortisone and FGF2 in Huber’s culture medium with the only difference from the claims being substitution of equivalents and identification of optimal working concentration. Furthermore, there is no evidence of record that such differences are critical or produce superior results to an unexpected degree. Thus, in teaching hydrocortisone and FGF2, Huber, Alharbi, Valk and Kakudo render the instantly claimed concentrations prima facie obvious.
Regarding claims 4 and 5, as detailed in the claim interpretation section above, prior art that renders instantly claimed composition prima facie obvious renders the factors and their ratio-metric relationship recited in claims 4 and 5 prima facie obvious since these would inherently result from the method of claim 1. Thus, Huber, Alharbi, Valk and Kakudo that render claims 1 and 2 prima facie obvious, also render claims 4 and 5 prima facie obvious.
Regarding claims 8, 9, 18, 20, claims 18 and 20 are duplicates of claim 8; as noted in the Duplicate Claim Warning above. Claims require formulating the mature adipocyte composition with a pharmaceutically acceptable carrier. As noted above, Huber and Alharbi teach a mature adipocyte composition of claims 1, 2, 4 and 5. This composition comprises buffers, HEPES, that are pharmaceutically acceptable and thus meet the limitation of claims 8, 9, 18, 20.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in
the art at the effective time of filing of the invention, especially in the absence of evidence to the
contrary.
Claim(s) 6, 7, 10, 12, 13, 14, 16, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huber et al (Tissue Engineering: Part C, Vol. 21, Nov. 12, 2015; ref of record), Alharbi (Journal of Plastic, Reconstructive & Aesthetic Surgery (2013) 66, 1271-1278; ref of record) and Kakudo et al (Biochemical and Biophysical Research Communications 359 (2007) 239–244) in view of Cohen et al (Aesthetic Surgery Journal Open Forum, September 2019, pg. 1-11) and Valk et al (Toxicology in Vitro 24 (2010) 1053–1063; ref of record) as evidenced by Zhang et al (Journal of Endocrinology (2000) 164, 119–128; ref of record) as applied to claim 1, 2, 4, 5 above, and further in view of Yanaga et al (24th Annual Meeting of Japanese Breast Cancer society, 2016, p. 364, Abstract DP-2-63-4, Tokyo, Japan; ref of record).
As noted in the Duplicate Claim Warning above, claims 10, 12, 13, 14, 16, 17 are duplicates of claims 6 and 7.
The teachings of Huber, Alharbi, Kakudo, Cohen, Valk, Zhang, presented in the U.S.C. 103 rejection above are relied upon for the instant rejection.
Huber, Alharbi and Kakudo in view of Valk and Cohen, as evidenced by Zhang, teaches the mature adipocyte composition of claims 1, 2, 4, 5.
Huber suggests the use of their composition in implants (page 1243, col. 2, para 1). Huber and Alharbi do not teach administering their composition to a human patient wherein the administration is performed for augmenting subcutaneous adipose tissue or augmentation mammaplasty or breast reconstruction surgery or tissue recess reconstruction surgery. However use of mature adipocytes in augmenting subcutaneous adipose tissue such as augmentation mammaplasty, breast reconstruction surgery or tissue recess reconstruction surgery were known.
Yanaga teaches administering cultured adipocytes during surgeries for “4 cases of postoperative scaring, 8 cases of postoperative implant deformity, 2 cases of postoperative
myocutaneous valve deformity, 2 cases of total mastectomy, and 2 cases of breast atrophy.” to human patients (as required for claims 7, 14, 16, 17; Purpose, Subjects and Methods). Each of these surgeries are for augmenting a subcutaneous adipose tissue (as required by claims 6, 10, 12, 13). Therefore, Yanaga teaches administering mature adipocytes in at least augmentation mammaplasty (in case of total mastectomy), breast reconstruction surgery (in case of breast atrophy) which are for augmenting a subcutaneous adipose tissue.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the mature adipocyte composition of Huber, Alharbi and Kakudo in at least augmentation mammaplasty, breast reconstruction surgery, as taught by Yanaga. An ordinary artisan would be motivated to use Huber, Alharbi and Kakudo’s mature adipocyte composition in Yanaga’s method because although Yanaga teaches that they cultured adipocytes for 4 weeks and that their method results in highly satisfied patients (Subjects and Methods , and Results), Yanaga do not teach the method for culturing adipocyte. Such a method is taught by Huber, Alharbi and Kakudo. An ordinary artisan would reasonably expect to administer Huber, Alharbi and Kakudo’s mature adipocyte composition to human patients because Yanaga teaches that cultured adipocyte can be administered to human patients.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in
the art at the effective time of filing of the invention, especially in the absence of evidence to the
contrary.
Response to Arguments
Applicant's arguments filed 3/19/2026 regarding the Double patenting Objections have been fully considered but they are not persuasive.
Regarding the double patenting objection of claims 6, 10, 12, 13, Applicant argue that “Because the underlying compositions differ in their structural and biochemical characteristics, the methods defined in these claims are directed to distinct embodiments and are not duplicative.” (page 5, para 6). Applicant do not address the double patenting objection of claims 7, 14, 16, 17. Applicant do not address the double patenting objection of claims 8, 18 and 20.
In response, as noted in the double patenting objection, the underlying compositions of claim 1, 2, 4 and 5 do not differ structurally and thus not biochemically. Claim 1 sets forth the method steps that derive the mature adipocyte-containing composition from adipose tissue. Claim 2 provides a step that occurs before the steps recited in claim 1 such that the mature adipocyte-containing composition derived from the method of claim 2 is the same as the method of claim 1. Claims 4 and 5 do not recite additional method step but identify factors present in the conditioned media of claim 1, thus the mature adipocyte composition of claim 1 inherently comprises the factors recited in claims 4 and 5 such that the mature adipocyte-containing composition derived from the method of claim 4 and 5 are the same as the method of claim 1. Thus, amendments to claims 6, 10, 12, 13 do not overcome the objection.
Applicant’s arguments with respect to the U.S.C. 103 rejection of claim(s) 1, 2, 4, 5, 8, 9, 18, and 20 and claims 6, 7, 10, 12, 13, 14, 16, and 17 have been considered but are moot because the new ground of rejection necessitated by claim amendments.
Arguments pertinent to instant U.S.C. 103 rejection of the claims are addressed below.
Applicant argue that “Alharbi simply taught the use of different sized cannulas in fat harvesting but did not teach an enzyme-free method to shred adipose tissue into micronized fats.” because “Alharbi examines whether fat-harvesting procedures using different cannulas of small diameters will impact the properties of lipoaspirates” while “The present invention instead employs mechanical shredding followed by centrifugal separation to obtain microfat without enzymatic digestion” (page 7, para 1 and 2).
In response, indeed Alharbi use different size cannulas to harvest tissue, specifically “micro fats” (see “Micro-fat-harvesting technique” on page 1273). This is an enzyme-free step. Alharbi then culture these microfats (see “Testing fat tissue viability and survival rate in vitro” on page 1273 stating “In parallel, purified lipoaspirates obtained from conventional fat-harvesting or micro-fat-harvesting procedures were transferred into a six-cell culture plate”). Applicant do not identify how Alharbi’s cannula-based mechanical shredding of adipose tissue to produce microfats is different from claimed “mechanical shredding”. To this end, as was noted in the now withdrawn U.S.C 112(a) rejection in OA dated 6/24/2025, the specification does not provide any description for how shredding and filtration was performed. However, Applicant persuasively argued that any routine shredding and filtration could perform these steps. Taken together, there is no evidence that Applicant’s mechanical shredding or claimed mechanical shredding is not met by Alharbi’s cannula-based mechanical shredding.
Applicant’s arguments pertaining to specific culture medium conditions newly added to the claims and cytokine profile generated from the now amended claims are addressed in the new grounds of rejection above (page 7, 8).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATASHA DHAR whose telephone number is (571)272-1680. The examiner can normally be reached M-F 8am-4pm (EST).
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/MATASHA DHAR/Examiner, Art Unit 1632
Prosecution Insights