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 .
Claims 39-43,45,49-56 are under examination.
Request for Continued Examination
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 5, 2026 has been entered.
Response to Applicants Arguments/Amendments
The recent amendments have changed the scope of the claims. Therefore, the former rejections are withdrawn and new rejections put forth. Applicants argue that the declaration dated August 13, 2025 show the criticality of the claimed amount (200 mg) of placental composition administered. The examiner was not persuaded by the declaration dated August 13, 2025. The independent claims are so broad that they encompass treating any type of musculoskeletal disorder. However, the declaration dated August 13, 2025 focuses only on treating osteoarthritis which is just one type of musculoskeletal disease (Page 2). Page 3 of the declaration discusses potency assays used to measure the anti-inflammatory levels impacted by of the placental formulation recited in the claims. The instant claims are so broad that they encompass any form of musculoskeletal treatment and are not limited to only controlling the levels of some cytokines and catabolic effects shown in pages 3-5 of the declaration.
Pages 8-9 discuss a clinical study that involves treating individuals with osteoarthritis by administering to these subjects a placental particulate composition. This study presented in the declaration is problematic for several reasons. The clinical study presented in the declaration does not indicate what is present in the placental particulate such as the precise amount of chorion, amnion, and umbilical cord material. It is not clear if all the individuals with osteoarthritis receiving the treatment had the exact same formulation of placental particulate composition. Instant claim 39 recites a composition where the range of each component is broadly claimed (amniotic membrane 10-30 wt%), chorionic membrane (30-75 wt%), and umbilical cord material (5-50 wt %). Thus, the instant claims do not recite a specific formulation. Furthermore, claim 55 only requires the presence of amnion and umbilical cord material, and claim 56 only requires the presence of umbilical cord material. Applicants’ arguments would be more persuasive if applicant could show that each individual received the exact same composition with the exact same concentration of each placental component and the claims were amended to recite the specific formulation given to study participants. Furthermore, applicants have not shown that each component (umbilical cord, chorion, and amnion) at each point in the concentration ranges recited in the claims produce the same effect in treating the osteoarthritis. Each component of the placental tissue particulate is associated with a very broad range which produces significantly different formulations.
The clinical study shows that participants in the study are either given no treatment, 100 mg of the placental tissue particulate, or 200 mg of the placental tissue particulate. However, the declaration does not clearly state the exact composition with the precise concentrations of chorion, amnion, and umbilical cord that are administered to the participants in the study. The instant claims do not recite one specific formulation. Concentration ranges are recited in the instant claims for the umbilical cord, chorion, and amnion material which can result in a multitude of formulations used to treat musculoskeletal disorders, not just osteoarthritis.
Conclusion: The examiner was not persuaded by the declaration dated August 13, 2025 because a specific placental tissue particulate formulation with distinct critical concentrations of chorion, amnion, and umbilical cord was not shown to produce unexpected and/or improved results when treating all forms of musculoskeletal disorders.
Claim Objections
Claims 52 and 55 are objected to because of the following informalities: “HA” is an abbreviation and needs to be written out. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 55 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 55 recites “at least about 5 wt%.” This is indefinite because “at least” means that the amount must be the stated value or more. However, “about” means that the amount can be both less than or greater than a stated value. Because of this conflict, the term “at least about” is indefinite.
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.
Claims 39-40,42-43,45,49-54 are rejected under 35 U.S.C. 103 as being unpatentable over Tseng (US 20150342998) in view of Tseng II (US 20140147511)
and Daniel (US 20140017280). Daniel is already of record and has been used in previous office actions.
Tseng teaches a therapeutic composition that comprises morselized amniotic membrane tissue and morselized umbilical cord tissue (Abstract). Paragraph 27 of Tseng further states that the mixture of morselized amniotic membrane tissue and umbilical cord can be in any ratio from 0.001:99.999 w/w% to 99.999:0.001 w/w % and can be morselized from either fresh or frozen tissue. The morselized tissue pieces can range in size from about 0.1 mm to about 1.0 cm in length, width, or thickness which would be consistent with a particle size (Paragraph 27 of Tseng). Tseng teaches that the proportion of UCAM (umbilical cord and amnion) described herein in the compositions can vary from between 0.01% to about 99.9 wt.% of the total amount of the composition (Paragraph 54 of Tseng). Thus, Tseng suggests that the amount of morselized amnion can be roughly 0.001 to 99.999% of the entire composition and the amount of morselized umbilical cord can similarly be in the range of roughly 0.001 to 99.999% of the entire composition. The umbilical cord used in Tseng can include all the umbilical cord components (Paragraphs 3-4 of Tseng). Tseng teaches that the resulting morsels can be further homogenized (Paragraph 27 of Tseng) and lyophilized/dehydrated (Paragraphs 6 and 31-33 of Tseng) as in instant 39.
Tseng teaches that its composition can be used as a treatment (Paragraphs 6 and 12 of Tseng). In paragraph 84, Tseng mentions that the composition can be used to treat conditions such as rheumatoid arthritis which is considered a musculoskeletal disorder that causes damages to joints, bones, and the surrounding tissue. Tseng does not teach administering the composition to the knees specifically. However, Tseng II teaches that such a placental tissue particulate composed of whole umbilical cord, amnion, and chorion (Paragraphs 3, 33, and 46 of Tseng II) can be used to treat a host of conditions including osteoarthritis, rheumatoid arthritis, septic arthritis, ankylosing spondylitis by injecting the placental tissue particulate directly into a joint such as a knee (Paragraph 245 of Tseng II). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have administered the treatment into an impacted knee as taught by Tseng II. An artisan would have been motivated to have treated a knee specifically because Tseng II discloses that a “placental/fetal support tissue power product disclosed herein is used to treat arthritis (e.g. osteoarthritis, rheumatoid arthritis, septic arthritis, ankylosing spondylitis, spondylosis). In some embodiments, a fetal support tissue powder product disclosed herein is injected into an arthritis joint (e.g. a knee) (Paragraph 245 of Tseng II). Because paragraph 254 of Tseng II discloses that injection into a joint such as a knee can cure different types of arthritis, there would have been a high expectation for success as in instant Claim 39.
Paragraph 38 and Claim 14 of Tseng state that “at least some chorion tissue remains with the morselized amniotic membrane tissue.” Tseng is silent on the amount of chorion that can be included. However, Daniel teaches a placental therapeutic composition in which the amount of chorion is in the range of 20 to 60% (Paragraph 59 of Daniel). Daniel further teaches that the amount of amnion present can be 10 to 50% (Paragraph 59 of Daniel). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used the amount of chorion/amnion taught by Daniel. An artisan would have been motivated to have used that amount of chorion and amnion taught by Daniel because it can treat joints/bone (Paragraph 31 of Daniel). There would have been a high expectation for success because paragraph 31 of Daniel teaches that the composition with a percent weight of chorion of 20 to 60% can successfully treat a range of disorders and conditions associated with bones and joints (Paragraph 31 of Daniel) as in instant Claims 39,51.
The claim recites that the amount of particulate composition is at least 200 mg. The amount of particulate material used will be dependent upon the area of the joint that needs to be treated. MPEP § 2144.05 (II) states the following: 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 reAller, 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 reHoeschele, 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 reKulling, 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.”).
A review of the specification fails to provide evidence that the claimed concentration of the particulate composition is critical. Absent such evidence it would have been obvious to an artisan of ordinary skill at the time of effectively filing Tseng to try a finite number of possible concentrations of placental tissue particulate to predictably arrive at the claimed concentration through routine optimization. The amount needed would depend upon the size of the wound and/or damaged site. An artisan would have had a reasonable expectation of success in optimizing the concentrations because determining the amount of placental particulate was long established in the art as demonstrated by Tseng. Thus, the reference renders the instantly claimed concentration of at least 200 mg.
Since the 3 references cited teach the claim limitations, it would be expected that the placental particulate composition taught by the combination of the references would reduce pain as measured by a patient outcome score, causing more than an eight point difference in mean change from the baseline WOMAC pain score and delay the progression of tissue damage which can be measured by an X-ray and/or MRI as in instant Claims 39,42.
Dependent Claims taught by Tseng
Tseng teaches wherein the method comprises injecting a single localized injection of the therapeutically effective amount of the particulate composition (Claim 9 of Tseng) as in instant Claim 40. Tseng teaches wherein a second dose is administered within about two weeks (Paragraph 73 of Tseng) as in instant Claim 43. Tseng does not state that portions of the umbilical cord must be removed before being morselized; therefore, the umbilical cord can be morselized intact including all layers (Paragraphs 2-5 of Tseng) as in instant Claims 39,49-50. Tseng teaches wherein the particulate composition is dehydrated/lyophilized (Paragraphs 6 and 27 of Tseng) and filled with collagen (Paragraph 18 of Tseng) as in instant Claim 52. Tseng teaches wherein the particulate composition further comprises an antimicrobial agent or an antifungal agent (Paragraph 31 of Tseng) as in instant Claim 53.
Dependent Claims taught by Tseng II
Tseng II teaches that the material can consist of the whole umbilical cord (Paragraph 33 of Tseng II) as in instant Claims 39,49-50. Tseng II teaches that the placental composition can include collagen, hyaluronic acid, or fibrin (Paragraph 18 of Tseng II) and be dehydrated (Paragraph 39 of Tseng II) as in instant Claim 52. Tseng II teaches that the musculoskeletal disease can be osteoarthritis, rotator cuff repairs, or a cartilage deficit (Paragraphs 21-22,64-65, 201, or 203 of Tseng II) as in instant Calm 54.
Dependent Claims taught by Daniel
Daniel teaches injecting a single therapeutically effective amount of the particulate composition (Paragraph 76 of Daniel) as in instant Claim 40.
Since the references teach the placental product of claimed composition, it would be expected that the placental product produced by combining the teachings of the references cited would also be capable of reducing pain by more than an eight point difference form a baseline WOMAC pain score as in instant Claim 42. Furthermore, Tseng II mentions that such a particulate placental product also has growth factors (Paragraph 229 of Tseng II). Since the combined teachings of the references cited in the rejection also teach particulate placental material composed of amnion, chorion, and umbilical cord as recited in the claims, it would be expected that the particulate placental material taught in Tseng I, Tseng II, and Daniel would also be capable of producing quantifiable amounts of beta FGF, IL-1Rα,IL-1α, TIMP-1,TIMP-2,TIMP-3, and fibronectin as in instant Claim 45.
Tseng teaches a therapeutic composition containing amnion, chorion, and umbilical cord particulate material that can be used to treat musculoskeletal disorders such as rheumatoid arthritis. Tseng does not teach administering the placental particulate composition to a knee; however, Tseng II teaches that injecting such as composition into the knee is possible in order to treat conditions such as rheumatoid arthritis and/or osteoarthritis. An artisan would have been motivated to have administered such a treatment to the knee since that is a region that is commonly impacted by musculoskeletal disorders such as arthritis. Although Tseng and Tseng II mention that chorion material may be present in such a particulate composition, these references fail to state the precise amount of chorion material that may be present. However, Daniel teaches a placental particulate composition which is used to target bone/joint conditions. Daniel teaches an amount of chorion in its particulate composition within the range recited in the claims. An artisan would have been motivated to have used such an amount of chorion in a placental composition because Daniel teaches a placental composition with that concentration of chorion material used to treat bone/joints. Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants invention, it must be considered, absent evidence to the contrary that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combinations would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. V. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature. These people will have the practical knowledge in molecular biology and placental product preparation. Therefore, the level of ordinary skill in the art is high.
Claim 40-43,45,49-54 are rejected under 35 U.S.C. 103 as being unpatentable over Tseng (US 20150342998) in view of Tseng II (US 20140147511), Daniel (US 20140017280), and Brahm (US 20150088062). Brahm is already of record and has been discussed in previous office actions.
Tseng, Tseng II, and Daniel apply as above to teach claims 40,42-43,45,49-54 . These references fail to teach monitoring the placental composition implant and detecting (60 days plus after administration) the implant in order to ensure that the implant material is effectively treating the patient and not causing unwanted complications. Brahm teaches that after implantation of therapeutic material in a joint, the patient receiving the implant attends monthly follow up visits to check for healing (detection at the site) and/or monitoring complications that could develop (Paragraph 134 of Brahm). Paragraph 134 of Brahm specifically discusses monthly visits 4 weeks post-surgery and 11-weeks post-surgery (Paragraph 134 of Brahm). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have implemented the monitoring/detection taught by Brahm. An artisan would have been motivated to have implemented such monitoring/detection in order to ensure that the placental implant material was effectively healing in the wound area and that the patient was experiencing no pain after introduction of the implant material (Paragraph 134 of Brahm). Because monitoring and detection can be effectively used to assess the success of implanted material, there would have been a high expectation for success (Paragraph 134 of Brahm) as in instant Claim 41.
Tseng teaches a therapeutic placental composition containing amnion, chorion, and umbilical cord particulate material that can be used to treat musculoskeletal disorders such as rheumatoid arthritis. Tseng does not teach administering placental particulate composition to a knee joint; however, Tseng II teaches that injecting such a composition into the knee is possible in order to treat conditions such as rheumatoid arthritis and/or osteoarthritis. An artisan would have been motivated to have administered such a treatment to the knee joint since that is a region that is commonly impacted by musculoskeletal disorders such as arthritis. Although Tseng and Tseng II mention that chorion material may be present in such a placental particulate composition, these references fail to state the precise amount of chorion material that may be present. However, Daniel teaches a placental particulate material which is used to treat bones/joints. Daniel teaches an amount of chorion in its particulate composition recited within the range. An artisan would have been motivated to have used such an amount of chorion because Daniel teaches that such a composition can treat bone/joints. Furthermore, an artisan would have been motivated to have used the post implant monitoring taught in Brahm in order to ensure that the implant material was successfully adjusting to the wound and/or damaged site. Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants invention, it must be considered, absent evidence to the contrary that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combinations would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. V. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature. These people will have the practical knowledge in molecular biology and placental product preparation. Therefore, the level of ordinary skill in the art is high.
Claims 55-56 are rejected under 35 U.S.C. 103 as being unpatentable over Tseng (US 20150342998) in view of Tseng II (US 20140147511)
Tseng teaches a composition that comprises morselized amniotic membrane tissue and morselized umbilical cord tissue (Abstract). Paragraph 27 of Tseng further states that the mixture of amniotic membrane tissue and umbilical cord can be in any ratio from 0.001:99.999 w/w to 99.999:0.001 w/w % and can be morselized from either fresh or frozen tissue. The morselized tissue pieces can range in size from about 0.1 mm to about 1.0 cm in length, width, or thickness (Paragraph 27 of Tseng). Tseng teaches that the proportion of UCAM (umbilical cord and amnion) described herein in the compositions can vary from between 0.01% to about 99.9 wt.% of the total amount of the composition (Paragraph 54 of Tseng). Thus, this reference suggests that the amount of morselized amnion can be roughly 0.001 to 99.999% of the entire composition. The amount of umbilical cord can similarly be in the range of roughly 0.001 to 99.999% of the entire composition. Both the range for the umbilical cord material and the amnion are very large. The umbilical cord material used in Tseng can include all the umbilical cord components (Paragraphs 3-4 of Tseng). Tseng teaches that the resulting morsels can be further homogenized (Paragraph 27 of Tseng). Tseng teaches wherein the particulate composition is dehydrated (Paragraph 27 of Tseng) and filled with collagen (Paragraph 18 of Tseng). Tseng teaches wherein the particulate composition further comprises an antimicrobial agent and an antifungal agent (Paragraph 31 of Tseng). Tseng teaches wherein the particulate composition is dehydrated (Paragraph 27 of Tseng) and filled with collagen (Paragraph 18 of Tseng. Tseng teaches wherein the particulate composition further comprises an antimicrobial agent and an antifungal agent (Paragraph 31 of Tseng) as instant claims 55-56.
Tseng teaches that its composition can be used as a treatment (Paragraphs 6 and 12 of Tseng). In paragraph 84, Tseng mentions that the composition can be used to treat conditions such as rheumatoid arthritis which is considered a musculoskeletal disorder that causes damages to joints, bones, and the surrounding tissue. Tseng does not teach administering the composition to the knee joints specifically. However, Tseng II teaches that such a placental powder product composed of whole umbilical cord, amnion, and chorion particulate material (Paragraphs 3, 33, and 46 of Tseng II) can be used to treat a host of conditions including osteoarthritis, rheumatoid arthritis, septic arthritis, ankylosing spondylitis by injecting the placental product directly into a joint such as a knee (Paragraph 245 of Tseng II). Tseng II teaches that the material can consist of the whole umbilical cord (Paragraph 33 of Tseng II). Tseng II teaches that the placental composition can include collagen, hyaluronic acid, or fibrin (Paragraph 18 of Tseng II) and be dehydrated (Paragraph 39 of Tseng II)
It would have been obvious to an artisan of ordinary skill at the time of effective filing to have administered the treatment into an impacted knee as taught by Tseng II. An artisan would have been motivated to have treated a knee specifically because Tseng II discloses that “placental/fetal support tissue power product disclosed herein is used to treat arthritis (e.g. osteoarthritis, rheumatoid arthritis, septic arthritis, ankylosing spondylitis, spondylosis). In some embodiments, a fetal support tissue powder product disclosed herein is injected into an arthritis joint (e.g. a knee) (Paragraph 245 of Tseng II). Because paragraph 254 of Tseng II discloses that injecting a composition of umbilical cord, amnion, and chorion particulate material into a joint such as a knee can cure different types of arthritis, there would have been a high expectation for success as in instant Claims 55-56.
Since the references cited teach the claim limitations, it would be expected that the placental particulate taught by the combination of the references would reduce pain as measured by a patient outcome score and delay the progression of tissue damage which can be measured by an X-ray and/or MRI as in instant Claims 55-56.
The claim recites that the amount of particulate composition administered is at least 200 mg. The amount of particulate material used will be dependent upon the area of the joint that needs to be treated. MPEP § 2144.05 (II) states the following: 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 reAller, 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 reHoeschele, 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 reKulling, 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.”).
A review of the specification fails to provide evidence that the claimed concentration administered is critical. Absent such evidence it would have been obvious to an artisan of ordinary skill at the time of effectively filing Tseng to try a finite number of possible concentrations of placental particulate material to administer/inject to predictably arrive at the claimed concentration through routine optimization. The amount needed would depend upon the size of the wound. An artisan would have had a reasonable expectation of success in optimizing the concentrations because determining the amount of placental particulate was long established in the art as demonstrated by Tseng. Thus, Tseng renders the instantly claimed concentration of 200 mg above.
Tseng teaches a therapeutic composition containing amnion, chorion, and umbilical cord particulate material that can be used to treat musculoskeletal disorders such as rheumatoid arthritis. Tseng does not teach administering placental particulate composition to a knee joint; however, Tseng II teaches that injecting such as composition into the knee is possible in order to treat conditions such as rheumatoid arthritis and/or osteoarthritis. An artisan would have been motivated to have administered such a treatment to the knee since that is a region that is commonly impacted by musculoskeletal disorders such as arthritis as taught by Tseng II. Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants invention, it must be considered, absent evidence to the contrary that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combinations would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. V. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature. These people will have the practical knowledge in molecular biology and placental product preparation. Therefore, the level of ordinary skill in the art is high.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 39-43,45,49-51,54,56 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-10, and 13 of copending Application No. 17/778,333 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of 17/778,333 represent a species of 18/608,371. Application 17/778,333 teaches a species of claim 39 because claims 8 and 10 of Application 17/778,333 teaches a method of treating a musculoskeletal disorder in a subject by administering multiple doses of a placental composition that comprises about 10wt% to about 30wt% amniotic particles, 30wt% to about 75wt% chorion membrane particles, and about 5wt% to about 50wt% umbilical cord particulates. The composition is a specie because it requires that multiple doses of the composition are administered to said subject, a first and second dose of said multiple doses are administered at least one week to one month apart. Therefore claims 8 and 10 of Application 17/778,333 teach the limitation of instant claim 39. Furthermore, the administered composition described in instant claims 40-42,45,49-50 is not different from the composition taught by instant claim 39 because these claims do not alter the structure of the administered composition or the function of such a composition. Instant Claim 43 states that a second dose is administered within about two weeks. Claim 13 of Application 17/778,333 stress that multiple administrations are accomplished. Instant claim 51 corresponds to claims 8 and 10. Instant claim 54 corresponds to claim 9 of Application 17/778,333. Instant claim 56 also corresponds to claims 8 and 10. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to the Double Patenting Rejection
Applicants have not submitted a terminal disclaimer so the double patenting rejection remains. Applicants have only argued that the instant claims are not obvious over Application 17/778,333 without providing additional arguments and/or reasoning.
Conclusion
All claims stand rejected.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638