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 .
Status of Claims
Claims 1, 3, 6, 8-9, 11-12, 14, 20-21, 23, 30, 32-34, 41, 44, 46-47, and 49.
Priority
Claims 1, 3, 6, 8-9, 11-12, 14, 20-21, 23, 30, 32-34, 41, 44, 46-47, and 49 are a 371 of PCT/US 2023/019100 filed on April 19, 2023, which has priority to PRO 63/332.749 filed on April 20, 2022.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on October 21, 2024, and on November 1, 2024, and on March 24, 2026, and April 9, 2026. The Non-Patent Literature is in compliance with the provisions of 37 CFR 1.97 and are being considered by the examiner.
Drawings
The drawings are objected to because:
Figures 5-12 are not legible.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, 6, 8-9, 11, 14, and 41 are rejected under 35 U.S.C. §102(a)(1) as being anticipated by Beaudry et al. [US 2016 375064 A1].
Regarding claim 1, Beaudry et al. teaches a multi-processed human amniotic composition configured for treatment of Peyronie’s disease [¶ 0005, Fig. 1A, 0049] by intracorporeal injection in a subject in need thereof with an effective amount of the multi-part processed human amniotic composition [¶ 0049, 0010], the multi-part processed human amniotic composition comprising:
a micronized human amnion composition [¶ 0010, Fig. 1A]; and
an aqueous human amniotic fluid filtrate configured to reconstitute and suspend the micronized human amnion composition therein [¶ 0005], wherein:
the multi-part processed human amniotic composition are not processed with exogenous enzymes during production thereof and do not include exogenous enzymes added thereto [Example 1].
Regarding claim 3, Beaudry et al. teaches the multi-part processed human amniotic composition configured for treatment of Peyronie’s disease by intracorporeal injection according to claim 1, wherein the micronized human amnion composition has a particle diameter size ranging from greater than 1 µm to less than 300 µm [¶ 0009].
Regarding claim 6, Beaudry et al. teaches the multi-part processed human amniotic composition configured for treatment of Peyronie’s disease by intracorporeal injection according to claim 1, wherein the micronized human amnion composition comprises hyaluronic acid (HA) and/or hyaluronan, fibronectin, insulin growth factor binding protein-1 (IGFBP-1), sulfated glycosaminoglycans (sGAGs), exosomes, interleukin-1 receptor antagonist (IL-1ra), hepatocyte growth factor (HGF), transthyretin, or any combination thereof [¶ 0130].
Regarding claim 8, Beaudry et al. teaches the multi-part processed human amniotic composition configured for treatment of Peyronie’s disease by intracorporeal injection according to claim 1, wherein the aqueous human amniotic fluid filtrate comprises hyaluronic acid (HA) and/or hyaluronan, fibronectin, insulin growth factor binding protein-1 (IGFBP-1), sulfated glycosaminoglycans (sGAGs), exosomes, interleukin-1 receptor antagonist (IL-1ra), hepatocyte growth factor (HGF), transthyretin, or any combination thereof [¶ 0130].
Regarding claim 9, Beaudry et al. teaches the multi-part processed human amniotic composition configured for treatment of Peyronie’s disease by intracorporeal injection according to claim 1, wherein the aqueous human amniotic fluid filtrate further comprises an isotonic solution [¶ 0005].
Regarding claim 11, Beaudry et al. teaches, the multi-part processed human amniotic composition configured for treatment of Peyronie’s disease by intracorporeal injection according to claim 1, wherein the aqueous human amniotic fluid filtrate comprises particles that are less than 70 µm in diameter therein [¶ 0009].
Regarding claim 14, Beaudry et al. teaches the multi-part processed human amniotic composition configured for treatment of Peyronie’s disease by intracorporeal injection according to claim 1, wherein the micronized human amnion composition and the aqueous human amniotic fluid filtrate are configured for admixing at a ratio of 1 cm2: 1 ml to 2 cm2: 1 ml [¶ 0126].
Regarding claim 41, Beaudry et al. teaches a method of treating Peyronie’s disease in a subject in need thereof, comprising:
providing the multi-part processed human amniotic composition configured for treatment of Peyronie’s disease of claim 1; and
injecting the multi-part processed human amniotic composition configured for treatment of Peyronie’s disease at an effective amount into a corpus cavernosum in the subject in need thereof thereby treating Peyronie’s disease, reducing symptoms associated with Peyronie’s disease, and/or reducing plaque size associated with Peyronie’s disease in the subject in need thereof [¶ 0049].
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 12, 20, 21, 23, 30, 32, 33, 34, 44, 46, 47, and 49 are rejected under 35 U.S.C. §103 as being unpatentable over Beaudry et al. [US 2016 375064 A1], in view of Werber et al. [US 2015 035749W], in view of Ames et al. [US 2017 216195 A1], in view of Vascotto et al. [Oxidized transthyretin in amniotic fluid as an early marker of preeclampsia, Journal of Proteome Research, 2006], in view of Brahm [US 2016 082152A1], in view of Spencer and Sith (Hereinafter Spencer) [US 2015 335686 A1].
For claim 12, Beaudry et al. and Ames et al. teach the presence of such things as hyaluronic acid, fibronectin, etc. [¶ 0024, 0063, respectively]. Additionally, MPEP § 2144(II)(A) states “…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)”. Furthermore, MPEP § 2144(II)(A) goes on to state “"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." Lastly, the Markush listing in claim 12 are known elements found in amnionic fluid. For instance, Vascotto et al. teaches transthyretin is a known marker present in amnionic fluid [Abstract]. Here, it would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the claimed invention to modify the systems and methods of Beaudry et al. and Ames et al. that disclose an amniotic composition that can be used in various treatments that a person of ordinary skill would have known that components such as hyaluronic acid, transthyretin, exosomes, as well as other factors, are naturally present in amniotic fluid.
For claim 20 where the multi-part processed human amniotic composition for the treatment of Peyronie’s disease is contained in a kit, both Werber et al. and Ames et al. teach the use of kits and/or packaging [¶ 0002 and 0017, respectively].
For claim 21 where the kit does not include collagenase, Ames et al. teaches that although there are a number of decellularization methods known in the art that include the use of collagenase, methods that are better suited for preserving the extracellular matrix structure are preferred [¶ 0040].
For claim 23 where the micronized human amnion composition has a particle diameter size ranging from greater than 1µm to less than 300 µm, Beaudry et al. teaches that particle size can range anywhere from 0.5 µm to 10 µm which includes sizes larger than Applicant’s 1 µm and smaller than the Applicant’s claimed less than 300 µm [¶ 0009].
For claim 30 where the aqueous amnionic fluid filtrate further comprises an isotonic solution, Beaudry et al. also teaches the use of Plasma Lyte-A, an isotonic solution [¶ 0005]. Here, it would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the claimed invention to modify the systems and methods of Beaudry et al. that discloses a human amniotic composition that can be used in the treatment of Peyronie’s disease where the particle size is greater than 1 µm and less than 300 µm and where the aqueous human amniotic fluid filtrate contains an isotonic solution, such as Plasma Lyte-A can be included in a kit and/or packaging for use to be administered to a subject in need where the kit does not include any agents such as collagenase that are capable of further breaking down the extracellular matrix particles of the amniotic composition and other components. Given this, there is a reasonable expectation of success that a person of ordinary skill would recognize the teachings of Beaudry et al., Ames et al. and Werber et al. in order to create a human amniotic composition capable of treating Peyronie’s disease that could then be packaged in a kit for storage/administration to a person and/or patient diagnosed with Peyronie’s disease.
For claim 32, please see the analysis for claim 23.
For claim 33 where the micronized human amnion composition and the aqueous amniotic fluid filtrate are admixed at a ratio of 2:1 to 1:2, Beaudry et al. teaches combining amniotic derived components and varying the amount of amniotic fluid-derived material incorporated into the composition [¶ 0007]. The relative amounts of the components would have been recognized as a result-effective variable, and determining an appropriate relative amount would have been within the ordinary skill in the art through routine experimentation. The claimed 2:1 to 1:2 represents a selection of workable relative amounts absent evidence that the claimed range provided any unexpected results. See MPEP § 2144.05(II)(A) “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”.
For claim 34, please see the analysis for claim 12.
For claim 44 where the making of the multi-part processed human amniotic composition includes providing fresh amnion, separating the human amnion from other human placental components, rinsing with alcohol, washing the separate human amnion with an isotonic solution, etc., Beaudry et al. teaches a method of making a multi-part processed human amniotic composition (abstract, A therapeutic composite, i.e., a multi-part processed composition, may be a dispersion of micronized amniotic membrane combined with a fluid, such as plasma, saline, amniotic fluid, combinations thereof and the like [¶ 0008]. The micronized amniotic membrane may comprise hydrated mammalian amniotic tissue [¶ 0127]. The final therapeutic composite was prepared, i.e., a method of making) configured for treatment of Peyronie's disease by intracorporeal injection in a subject in need thereof (abstract, A therapeutic composite may be used to treat any number of conditions through topical application, surgical introduction, and/or injection [¶ 0010]. The concentration of particles, such as micronized amniotic membrane, in the therapeutic composition and or fluid component may be provided in any effective amount [¶ 0049], patients suffering from Peyronie's disease may be treated by injection to the affected area, i.e., by intracorporeal injection, of the penis), the method [¶ 0127]. The final therapeutic composite was prepared) comprising: (a) providing a human amnio [¶ 0124]. Three amniotic membrane samples, obtained from three separate donors [¶ 0008]. The micronized amniotic membrane may comprise hydrated mammalian amniotic tissue); (b) separating the human amnion from other human placental components (Para. [0126], Three amniotic membranes, i.e., separated from other human placental components, were obtained and rinsed using Plasma Lyte-A [¶ 0008]. The micronized amniotic membrane may comprise hydrated mammalian amniotic tissue); (c) rinsing the separated human amnion of step (b) [¶ 0126]. Three amniotic membranes were obtained and rinsed using Plasma Lyte-A [¶ 0008]. The micronized amniotic membrane may comprise hydrated mammalian amniotic tissue); (d) washing the separated human amnion of step (c) with an isotonic solution [¶ 0126], any remaining debris/blood was removed using sterile laps, i.e., an isotonic solution [¶ 0008]. The micronized amniotic membrane may comprise hydrated mammalian amniotic tissue); (e) drying separated human amnion of step (d) at ambient temperature for 2-6 hours in biosafety cabinet with circulating fan (optional), or in a dehydrator for 15 minutes to 1 hour at a temperature, thereby forming dried human amnion [¶ 0126], the amount of amniotic membrane needed to obtain a concentration of 1 cm2/ml of therapeutic solution was retained and placed on a sterile drying rack, i.e., a dehydrator, and allowed to dry for one hour); (f) grinding the dried human amnion thereby forming a micronized human amnion composition having particle diameters ranging from 1 to 500 microns [¶ 0126]. The amniotic membrane was then cut into small pieces, less than a 1 cm2 and placed inside a milling chamber containing a blunt impactor [¶ 0009]. Particles of amniotic membrane may have any suitable particle size, average particle size and particle sized distribution. For example, the amniotic membrane derived particles, or micronized particles, may have a particle size, or an average particle size of no more than about 10 µm, no more than about5 µm, no more than about 2 µm, no more than about 1 µm, no more than about 0.5 µm and any range between and including the average particle sizes provided = about 0.5 µm to about 10 µm); (a') providing a human amniotic fluid [¶ 0124]. Three fluid components were made and cell viability was measured as reported in Table 1.); (b') filtering the human amniotic fluid through a filter thereby forming a first human amniotic fluid filtrate [¶ 0007], an amniotic fluid may be first filtered, i.e., a first filtrate, to remove large debris and subsequently centrifuged to separate the cells from the amniotic fluid component. The fluid component may further be processed, such as by filtration to remove any particle); (c') filtering the first human amniotic fluid filtrate through a filter thereby forming a second human amniotic fluid filtrate [¶ 0007], an amniotic fluid may be first filtered to remove large debris and subsequently centrifuged to separate the cells from the amniotic fluid component. The fluid component may further be processed, such as by filtration, i.e., filtering the first filtrate, to remove any particle); (d') filtering the second human amniotic fluid filtrate through a 70-micron filter thereby forming a third human amniotic fluid filtrate [¶ 0007], an amniotic fluid may be first filtered to remove large debris and subsequently centrifuged to separate the cells from the amniotic fluid component. The fluid component may further be processed, such as by filtration, i.e., the second filtrate further processed, to remove any particle); (f') optionally diluting the third human amniotic fluid filtrate in a predetermined amount of a balanced salt solution thereby forming a dilute third human amniotic filtrate [¶ 0007], an amniotic fluid may be first filtered to remove large debris and subsequently centrifuged to separate the cells from the amniotic fluid component. The fluid component may further be processed, such as by filtration to remove any particle. In addition; the amniotic fluid component may be concentrated or diluted as desired diluted by addition of liquid, such as water or saline solution, i.e., diluting in a predetermined amount of a balanced salt solution); (i) mixing the micronized human amnion composition with either the third human amniotic fluid filtrate (optional) or the dilute third human amniotic filtrate thereby forming the multi-part processed human amniotic composition [¶ 0007], an amniotic fluid may be first filtered to remove large debris and subsequently centrifuged to separate the cells from the amniotic fluid component. The fluid component may further be processed, such as by filtration to remove any particle. In addition, the amniotic fluid component may be concentrated or diluted as desired. diluted by addition of liquid, such as water or saline solution [¶ 0127]. The final therapeutic composite was prepared by combining 100 ml or the fluid component and micronized amniotic membrane with equal volume (100 ml), of cryoprotectant solution. Using a repeater pipet, cryovials were then filled at the desired volume) configured for treatment of Peyronie's disease by intracorporeal injection, wherein none of the steps include introduction of exogenous enzymes [¶ 0124]. Three amniotic membrane samples, obtained from three separate donors, were cryo-fractured and dispersed in fluid to create a fluid component, as described herein [¶ 0127]. The final therapeutic composite was prepared by combining 100 ml or the fluid component and micronized amniotic membrane with equal volume (100 ml), of cryoprotectant solution. Using a repeater pipet, cryovials were then filled at the desired volume [¶ 0007]. In addition, the amniotic fluid component may be concentrated or diluted as desired diluted by addition of liquid, such as water or saline solution.
However, Beaudry et al. does not teach the use of fresh human amnion, fresh human amniotic fluid, rinsing the amnion with alcohol, drying the amnion at a temperature ranging from 30˚C to 40˚ C, filtering through a 200-micron filter, filtering through a 100-micron filter, and filtering through a 70-micron filter. For these limitations, Brahm teaches morselized amniotic membrane and an amniotic fluid for treatment of a disease or condition [Abstract, ¶ 0008] teaches (a) a fresh human amnion [¶ 0008]. The birth tissue material includes at least one morselized placental tissue component; Para. [0049], In a preferred embodiment, the human birth tissue material is subject to the method of preparation described herein no more than four hours after recovery to preserve cell viability); and (a') a fresh human amniotic fluid [¶ 0008]. The birth tissue material includes at least an amniotic fluid composition [¶ 0049]. In a preferred embodiment, the human birth tissue material is subject to the method of preparation described herein no more than four hours after recovery to preserve cell viability).
Additionally, Spencer teaches rinsing an amnion with an alcohol [¶ 0014], The term "placental tissue" means any and all of the well-known components of the placenta including but not limited to amnion, chorion, and the like, and including processed tissue. This includes dehydrated placental tissue and micronized placental tissue [¶ 0044], the chemical dehydration step is performed by contacting the Umbilical Cord Tissue with a polar organic solvent for a sufficient time and amount, i.e., rinsing. The solvent can be protic or aprotic. Examples of polar organic solvents useful herein include, but are not limited to, alcohols Specific, non-limiting examples include DMSO, acetone, tetrahydrofuran, ethanol, isopropanol, or any combination thereof.); and (e) drying the amnion at a temperature ranging from 30°C to 40°C [¶ 0014].
For claim 46 where steps (a)-(c) include removing blood clots present in the human amnion, Beaudry et al. discloses removing any blood clots present within the human amnion [¶ 0008].
For claim 47, Beaudry et al. teaches that the supernatant was washed with Plasma Lyte-A between centrifugation and that centrifugation occurred at least two times [¶ 0125].
For claim 49 where a grinding tool was used, Beaudry et al. teaches the use of a milling chamber where the grinding time was three minutes followed by intermediate cooling of two minutes [¶ 0127]. Although Applicant’s claim is directed to using a grinding tool configured to grind and/or mince the dried human amnion at 40 to 200 revolutions per minute resulting in a micronized human amnion composition with a particle size ranging from 1 to 500 microns, the milling chamber used in Beaudry et al. represents the same general operation, i.e. mechanically reducing amniotic tissue into smaller particles. Although, Beaudry et al. does not specifically teach the use of a grinding tool where the revolutions per minute are between 40 and 200, a person of ordinary skill in the art seeking to grind amnion would have been motivated to select a suitable grinding or milling apparatus and operating conditions capable of achieving the desired degree of size reduction. The selection of a particular grinding tool and operating speed, including the speed of the claimed range, would have been a matter of routine process selection based on desired particle size and characteristics of the resulting amnion particles and would not produce a different kind of amnion product from that produced from a milling chamber versus a grinding tool set to specific rpm, and given that the particle sizes produced by Beaudry et al. [¶ 0009] fall within the Applicant’s claimed range. Here, it would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the claimed invention to modify the systems and methods of Beaudry et al. to choose a mechanical grinding method in order to micronize the amnion in the respective particle sizes. Given this, there is a reasonable expectation of success that a person of ordinary skill would choose from a variety of known mechanical methods for grinding amnion in order to obtain a particle size within the claimed range given that Beaudry et al. discloses human amnion particle sizes within Applicant’s claimed range.
The Supreme court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable varition..103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions…
…the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) emphasis added.
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court reaffirmed "the conclusion that when a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273,282 (1976)). The Supreme Court also emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton.").
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims allowed.
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/JOHN DAVID MOORE/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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