DETAILED ACTION
Receipt is acknowledged of applicant’s Amendment/Remarks filed 8/4/2025.
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 the Claims
Claims 24-29 have been amended. Claims 1-23 are cancelled. Claims 30-35 are newly added. Accordingly, claims 24-35 remain pending in the application and are currently under examination.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application Nos. 61/677,011, 13/933,747, 15/082,421 and 16/250,304 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Said prior-filed applications do not contain support for the limitation “uniform mixture” as recited in the instant claims. Accordingly, instant claims 24-35 are afforded an effective filing date of April 3, 2022.
In addition, the disclosure of the prior-filed applications, Application Nos. 61/677,011 and 13/933,747 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Said prior-filed applications do not contain support for the limitation, “suitable copolymer” as recited in instant claim 29. However, prior-filed application 15/082,421 contains support for said limitation.
Interview Request
Applicant’s request for interview is acknowledged. However, time constraints did not permit such as interview to occur. It is also noted that a new Office policy is permitting one interview per round of prosecution and any subsequent interviews are only permitted if the interview advances prosecution and must be approved by a supervisor.
Maintained Rejections
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 24-29 stand rejected and newly added claims 30-33 and 35 are newly rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US 2008/0181967 A1, published July 31, 2008, hereafter as “Liu”) and Philipp (“Collagen Corneal Shields”, The Dry Eye Zone Forums, available online Sept. 13, 2005, hereafter as “Philipp”) as evidenced by Merriam-Webster (Definitions of “Soak” and “Rehydrate”; hereafter as “Merriam-Webster”) and Fan et al. (“Deciphering UVA/Riboflavin Collagen Crosslinking: A Pathway to Improve Biomedical Materials”, Adv. Funct. Mater. 2024, 34, 2401742, pp. 1-14; hereafter as “Fan”).
The claims are drawn to a lens-shaped patch for application to the cornea of an eye for the treatment of diseases and injuries to the cornea of an eye, comprising: a patch formed into the shape of a contact lens, wherein the patch is a uniform mixture of a biodegradable carrier material comprising collagen from a mammalian source or a suitable copolymer and wherein an active ingredient comprising an amniotic extract, a placental extract, or a combination thereof is incorporated into the uniform mixture; wherein an interior surface of the lens-shaped patch conforms to the external surface of the cornea and the lens-shaped patch adheres to the cornea, and wherein the lens-shaped patch degrades and completely dissolves while on the cornea and need not be removed within a pre-determined degradation period of time dependent on a cross-linking agent, and wherein the patch treats a medical condition selected from dry eye syndrome, corneal trauma, corneal inflammation, corneal burn injury, or corneal ulcers.
Regarding instant claims 24 and 29, Liu teaches compositions comprising placental tissue (e.g., amniotic membrane), umbilical cord membrane, or both for the purpose of treating conditions of the eye (abstract; [0006] and [0021]). Liu indicates that the membrane pieces are homogenized to produce an umbilical cord membrane suspension. Homogenization is repeated as necessary in order to obtain a visibly homogenous suspension and any particulate matter can be filtered out to produce a solution ([0060], [0072], [0141] and [0142], implying a uniform mixture). Liu teaches that a bandage contact lens comprising collagen, wherein the collagen is crosslinked by riboflavin and wherein the contact lens comprises a solution, gel or paste of the invention ([0011]-[0012], reads on the limitation of lens-shaped patch). Liu teaches that the bandage contact lens can be immersed, soaked or rehydrated in the solution comprising placental tissue (e.g., amniotic membrane), umbilical cord membrane, or both ([0011]-[0012] and [0117]-[0118]). Liu further discloses that a method of treating an ocular condition includes irritation, dry eye, symblepharon (implying eye trauma), red eye, inflammation of a tissue of an eye or injury ([0012], reads on the limitations regarding eye conditions).
Regarding the limitation, a “uniform mixture” of the biodegradable carrier and active ingredient, MPEP 2112.01(I) states,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
As discussed above, Liu teaches a bandage contact lens comprising crosslinked collagen immersed, soaked or rehydrated in a homogenous solution comprising placental tissue (e.g., amniotic membrane), umbilical cord membrane, or both. Rehydration is defined as “to restore fluid to (something dehydrated)” as evidenced by Merriam-Webster. Soak is defined as “to lie immersed in liquid (such as water): become saturated by or as if by immersion” or “to place in a surrounding element (such as liquid) to wet or permeate thoroughly” as evidenced by Merriam-Webster. Additionally, collagen crosslinked with riboflavin produces a porous structure as evidenced by Fan (paragraph bridging pages 3-4). In light of the evidentiary teachings, the soaking, immersing or rehydration of the porous collagen bandage contact lens in a homogenous solution comprising placental tissue (e.g., amniotic membrane), umbilical cord membrane, or both would result in a saturated collagen lens and thereby a uniform mixture of the biodegradable carrier (collagen) and the active ingredient (amniotic and/or placental extract). Where the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of either anticipation or obviousness has been established (MPEP 2112.01(I)).
While Liu teaches collagen, Liu does not expressly teach that the source of collagen is mammalian nor does Liu expressly teach that the lens-patch degrades and completely dissolves while on the cornea and need not be removed.
Philipp discloses collagen corneal shields (title). Philipp teaches that the collagen corneal shield is a newly developed, potentially multipurpose ophthalmic lens (1st paragraph, page 1/4, readable on the lens-shaped patch). Philipp teaches that collagen, in humans, is one of the most widespread and important proteins found in the body (1st paragraph, page 1/4, implying mammalian source). Philipp also teaches that collagen from porcine sclera (a mammalian source) and shaped in the form of a contact lens that can easily be placed on the surface of the eye is known (2nd paragraph, page 1/4). Philipp also teaches that the collagen shield is currently available to physicians for use among patients with dry eye syndromes (4th paragraph, page 1/4). Philipp teaches that early experience with this collagen “contact lens” showed that it was able to protect the ocular surface and also that it was dissolvable because the naturally occurring enzymes in the tear film causes the collagen contact lens to dissolve over a period of time (2nd paragraph, page 1/4).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include mammalian collagen as taught by Philipp as the particular biodegradable carrier material to be incorporated into the bandage contact lens of Liu with a reasonable expectation of success. A person of ordinary skill would have been motived to do so because Philipp teaches that collagen in humans is one of the most widespread and important proteins found in the body and because Philipp teaches using mammalian collagen for the same eye conditions (e.g., dry eye syndrome) as Liu. Thus, in view of the teachings of Liu and Philipp, there would have been a reasonable expectation that a lens-shaped patch comprising a collagen from a mammalian source and an active ingredient comprising a placental/amniotic extract could be successfully prepared and used in treating diseases of the eye.
Regarding the limitation, “a pre-determined degradation period of time dependent on a cross-linking agent”, the instant specification states that the rate of degradation of the collagen can be controlled by the degree of crosslinking, riboflavin can be utilized as a crosslinking additive in amounts of 0.05% to 0.75%, and UV irradiation can be utilized to induce crosslinking ([0070]). Liu teaches that, in a specific embodiment, the composition of the invention comprises collagen that is crosslinked by riboflavin ([0012], [0118], and claim 13). Liu teaches that the riboflavin is used to crosslink collagen proteins in a collagen-containing gel to improve or increase the mechanical strength of the gel ([0085], i.e., modify the degradation rate) and such a riboflavin solution can be about 0.01% to about 1% riboflavin, e.g., 0.1% ([0086]). Liu also teaches that the crosslinking occurs due to exposure to ultraviolet (UV) light for about 10 minutes to about 60 minutes ([0086]). MPEP 2144.05 states, “[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 (CCPA 1955)”. Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to optimize the amount of riboflavin and UV exposure time duration by way of routine experimentation to thereby optimize the amount of crosslinking of the collagen with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to do so because Liu teaches that the degree of crosslinking directly affects the mechanical strength (i.e., degradation rate) of said collagen. A skilled artisan would have reasonably expected a lens-shaped patch comprising collagen and a placental/amniotic extract having an optimized degree of crosslinking and, thereby, a desired amount of mechanical strength and degradation rate. While Liu does not explicitly teach a degradation time of one to thirty days or 8 to thirty days, Liu teaches the same process of making utilizing the same ingredients in the same amounts and optimization thereof. MPEP 2112.01(I) states,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Thus, a skilled artisan would reasonably expect that the prior art product of Liu/Philipp would possess the same characteristics including degradation time as the claimed product.
Regarding instant claim 25, Liu further teaches that the subject can be human ([0104]).
Regarding instant claims 26, 27, 30 and 31, Liu and Philipp teach the elements above. It is noted that the instant specification states that the rate of degradation of the collagen can be controlled by the degree of crosslinking, riboflavin can be utilized as a crosslinking additive in amounts of 0.05% to 0.75%, and UV irradiation can be utilized to induce crosslinking ([0070]). Liu teaches that, in a specific embodiment, the composition of the invention comprises collagen that is crosslinked by riboflavin ([0012], [0118], and claim 13). Liu teaches that the riboflavin is used to crosslink collagen proteins in a collagen-containing gel to improve or increase the mechanical strength of the gel ([0085]) and such a riboflavin solution can be about 0.01% to about 1% riboflavin, e.g., 0.1% ([0086]). Liu also teaches that the crosslinking occurs due to exposure to ultraviolet (UV) light for about 10 minutes to about 60 minutes ([0086]). MPEP 2144.05 states, “[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 (CCPA 1955)”. Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to optimize the amount of riboflavin and UV exposure time duration by way of routine experimentation to thereby optimize the amount of crosslinking of the collagen with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to do so because Liu teaches that the degree of crosslinking directly affects the mechanical strength of said collagen. A skilled artisan would have reasonably expected a lens-shaped patch comprising collagen and a placental/amniotic extract having an optimized degree of crosslinking and, thereby, a desired amount of mechanical strength. While Liu does not explicitly teach a degradation time of one to thirty days or 8 to thirty days, Liu teaches the same process of making utilizing the same ingredients in the same amounts and optimization thereof. MPEP 2112.01(I) states,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Thus, a skilled artisan would reasonably expect that the prior art product of Liu/Philipp would possess the same characteristics including degradation time as the claimed product.
Regarding instant claim 28, Liu and Philipp teach the elements above. Liu additionally teaches that, in a specific embodiment, the composition of the invention comprises collagen that is crosslinked by riboflavin ([0012], [0118], and claim 13). Liu teaches that the riboflavin is used to crosslink collagen proteins in a collagen-containing gel to improve or increase the mechanical strength of the gel ([0085]) and such a riboflavin solution can be about 0.01% to about 1% riboflavin, e.g., 0.1% ([0086]). Liu also teaches that the crosslinking occurs due to exposure to ultraviolet (UV) light for about 10 minutes to about 60 minutes ([0086]). MPEP 2144.05 states, “[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 (CCPA 1955)”. Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to optimize the amount of riboflavin and UV exposure time duration by way of routine experimentation to thereby optimize the amount of crosslinking of the collagen with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to do so because Liu teaches that the degree of crosslinking directly affects the mechanical strength of said collagen.
Regarding instant claims 32 and 33, the references teach the elements discussed above. Specifically, Liu teaches that the riboflavin is used to crosslink collagen proteins in a collagen-containing gel to improve or increase the mechanical strength of the gel ([0085]) and such a riboflavin solution can be about 0.01% to about 1% riboflavin, e.g., 0.1% ([0086]). Liu also teaches that the crosslinking occurs due to exposure to ultraviolet (UV) light for about 10 minutes to about 60 minutes ([0086]). It is understood in the art that the amount of crosslinking agent and the UV exposure duration effect the degree of crosslinking and optimizing one or both variables will modify the degree of crosslinking and thereby the mechanical properties/degradation rate.
Regarding instant claim 35, said claim recites, “wherein the pre-determined period of time is further based on a variation of one or more of: type of added co-polymer, and ratio of the co-polymer to the active ingredient”. Said claims depends from 29. Claim 29 recites, “a biodegradable carrier material comprising collagen or a suitable co-polymer”. Accordingly, claim 29 allows for the selection of collagen or a suitable co-polymer. Claim 35 does not set forth that a co-polymer is required as the biodegradable carrier material. As such, the limitations of claim 35 are not relevant when collagen is selected as the biodegradable carrier material and are, thus, considered optional. Liu and Philipp teach collagen and, thus, meet the optional limitations of the claim.
Thus, the combined teachings of Liu and Philipp render the instant claims prima facie obvious.
Response to Arguments
Applicant's arguments, filed 8/4/2025, regarding the 103 rejection over Liu and Philipp have been fully considered but they are not persuasive.
Applicant argues that the cited references do not teach a uniform mixture. Remarks, pages 6-7 and 10-12.
In response, it is respectfully submitted that Liu teaches the membrane pieces are homogenized to produce an umbilical cord membrane suspension. Homogenization is repeated as necessary in order to obtain a visibly homogenous suspension and any particulate matter can be filtered out to produce a solution ([0060], [0072], [0141] and [0142], implying a uniform mixture). Thus, Liu effectively teaches that the umbilical cord suspension can be filtered to yield a uniform solution/mixture. Liu also teaches a bandage contact lens comprising collagen (crosslinked with riboflavin) immersed, soaked or rehydrated in a homogenous solution comprising placental tissue (e.g., amniotic membrane), umbilical cord membrane, or both. Rehydration is defined as “to restore fluid to (something dehydrated)” as evidenced by Merriam-Webster. Soak is defined as “to lie immersed in liquid (such as water): become saturated by or as if by immersion” or “to place in a surrounding element (such as liquid) to wet or permeate thoroughly” as evidenced by Merriam-Webster. In addition, collagen crosslinked with riboflavin produces a porous structure as evidenced by Fan (paragraph bridging pages 3-4). In light of the evidentiary teachings, the soaking, immersing or rehydration of Liu’s porous collagen bandage contact lens in a homogenous solution comprising placental tissue (e.g., amniotic membrane), umbilical cord membrane, or both would result in a saturated collagen lens and thereby a uniform mixture of the biodegradable carrier (collagen) and the active ingredient (amniotic and/or placental extract). Where the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of either anticipation or obviousness has been established (MPEP 2112.01(I)). Contrary to applicant’s assertions, Liu meets the limitations regarding a uniform mixture absent evidence to the contrary.
Applicant argues that the instant application describes a uniform mixture in Example 2 at [0082]-[0083], see “The collagen mixture, SPE mixture, and riboflavin were blended together into a uniform mixture” at [0083]. Applicant also points to Example 1 which describes the mixture as a result of a solvent casting and molding process leads to a highly uniform, high optical transparency product. Applicant asserts that Liu does not teach a highly uniform and high optical transparency product. Remarks, pages 8-10.
In response, it is respectfully submitted that the instant claims are drawn to product claims and not method of making claims. The method in which the claimed product is made is immaterial to the patentability of the instantly claimed invention. In other words, if the product is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. MPEP 2113. Additionally, “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not” (MPEP 2112.01(I)). It is further noted that highly uniform and high optical transparency are not limitations in the claims. Thus, Applicant is arguing limitations that are not in the claims. Even assuming arguendo, Applicant has not met their burden in showing that the two products are different.
Applicant also argues that Liu [0117] suggests that a bandage contact lens is “made from biomaterial derived from placental tissue” etc. but this vague and not enabling. Applicant asserts that a prior art refence must be enabling, but Liu does not mention contact lenses in any of the examples. Applicant also asserts that bandage contact lenses “made from” placental tissue (etc.) will not be operative because placental materials do not have mechanical strength. Applicant further asserts that Liu [0118] suggests a bandage contact lens comprising collagen, but this paragraph does not suggest using such a collagen contact lens with a placental material. Remarks, pages 10-11.
In response, it is respectfully submitted that Liu teaches that a bandage contact lens comprising collagen, wherein the collagen is crosslinked by riboflavin and wherein the contact lens comprises a solution, gel or paste of the invention ([0011]-[0012]). Liu teaches that the bandage contact lens can be immersed, soaked or rehydrated in the solution comprising placental tissue (e.g., amniotic membrane), umbilical cord membrane, or both ([0011]-[0012] and [0117]-[0118]). Contrary to applicant’s assertion that Liu does not teach a collagen contact lens with a placental material, Liu’s teachings very clearly set out a collagen contact lens that is immersed, soaked or rehydrated in the solution comprising placental tissue (e.g., amniotic membrane), umbilical cord membrane, or both, i.e., a collagen contact lens comprising a placental solution. Regarding applicant’s enable argument, it is respectfully submitted that MPEP 2121 states that prior art is presumed to be operable/enabling. Affidavits or declarations attacking the operability of a patent cited as a reference must rebut the presumption of operability by a preponderance of the evidence (MPEP 716.07). It is noted that an affidavit or declaration has not been submitted by Applicant. It is also noted that MPEP 2164.03 states,
The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. Jn re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The "amount of guidance or direction" refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. Emphasis added.
In other words, if the prior art (before Liu) discloses how to make elements of Liu’s invention, then Liu need not teach how to make those elements because one of ordinary skill in the art would have had the knowledge already in their possession to make said elements and the predictability of the art would, therefore, be quite high. For example, Peyman (US 2005/0287223 A1, Dec. 29, 2005) provides evidence that a composition comprising amniotic membrane can be utilized to form a contact lens ([0005]) and in order to enhance the amniotic membrane rigidity, it may be treated with polymer and/or a crosslinking agent ([0006]). It should also be noted that a reference is relevant as prior art for all it contains and is not limited to only disclosed examples (MPEP 2123). Given the state of the art at the time of Liu, a skilled artisan would have had in their possession the knowledge of how to make the invention of Liu without undue experimentation.
Applicant argues that Li and/or Phillip do not teach a pre-determined degradation period of time dependent on cross-linking agent that is used in the uniform mixture. Remarks, page 12-16.
In response, it is respectfully submitted that the instant specification states that the rate of degradation of the collagen can be controlled by the degree of crosslinking, riboflavin can be utilized as a crosslinking additive in amounts of 0.05% to 0.75%, and UV irradiation can be utilized to induce crosslinking ([0070]). Liu teaches that, in a specific embodiment, the composition of the invention comprises collagen that is crosslinked by riboflavin ([0012], [0118], and claim 13). Liu teaches that the riboflavin is used to crosslink collagen proteins in a collagen-containing gel to improve or increase the mechanical strength of the gel ([0085], i.e., modify the degradation rate) and such a riboflavin solution can be about 0.01% to about 1% riboflavin, e.g., 0.1% ([0086]). Liu also teaches that the crosslinking occurs due to exposure to ultraviolet (UV) light for about 10 minutes to about 60 minutes ([0086]). MPEP 2144.05 states, “[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 (CCPA 1955)”. Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to optimize the amount of riboflavin and UV exposure time duration by way of routine experimentation to thereby optimize the amount of crosslinking of the collagen with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to do so because Liu teaches that the degree of crosslinking directly affects the mechanical strength (i.e., degradation rate) of said collagen. A skilled artisan would have reasonably expected a lens-shaped patch comprising collagen and a placental/amniotic extract having an optimized degree of crosslinking and, thereby, a desired amount of mechanical strength and degradation rate. While Liu does not explicitly teach a degradation time of one to thirty days or 8 to thirty days, Liu teaches the same process of making utilizing the same ingredients in the same amounts and optimization thereof. MPEP 2112.01(I) states,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Thus, a skilled artisan would reasonably expect that the prior art product of Liu/Philipp would possess the same characteristics including degradation time as the claimed product. For these reasons, applicant’s argument is unpersuasive.
Applicant argues that the mere practical application of Phillip was quite limited as that compared to the claimed product. Applicant asserts that there would not have been a reasonable expectation that a lens-shaped patch comprising collagen from a mammalian source and an active ingredient comprising a placental/amniotic extract could be successfully prepared and used in treating a list of diseases of the eye, as provided by claims 24 and 29, and limited to merely treating dry eye syndrome. Remarks, page 12.
In response, it is respectfully submitted that the instant claims are drawn to a product and not a method of using. However, the references are both drawn to ocular devices for the treatment of various ocular conditions such as irritation, dry eye, symblepharon, red eye, inflammation or injury. Thus, it would be reasonable to conclude that the product suggested by Liu/Phillip would be able to be used in treating diseases and injuries of the eye. Thus, applicant’s argument is not persuasive.
Thus, for these reasons, Applicant’s arguments are found unpersuasive. Said rejection is maintained.
New Objections/Rejections
In light of Applicant’s amendments, the following objections and rejections have been newly added:
Claim Objections
Applicant is advised that should claim 26 be found allowable, claim 30 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).
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.
Claims 32-34 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 32 recites the limitation "ratio of co-polymer to the active agent" in line 2 of the claim. Claim 32 depends form claim 24. The term “co-polymer” is not recited prior to the instant recitation in instant claims 24 or claim 32 and, as such, there is insufficient antecedent basis for this limitation in the claim. It is also unclear whether a co-polymer is or is not present in the composition.
Claim 32 recites the limitation "plasticizer concentration" in line 3 of the claim. Claim 32 depends form claim 24. The term “plasticizer” is not recited prior to the instant recitation in instant claims 24 or claim 32 and, as such, there is insufficient antecedent basis for this limitation in the claim. It is also unclear whether a plasticizer is or is not present in the composition.
Claim 32 recites the limitation "wherein the pre-determined period of time is based on a variation of one or more of… duration" in lines 1-2 of the claim. The claim is indefinite because it is unclear what duration is being varied.
Claim 33 recites the limitation "plasticizer concentration" in line 3 of the claim. Claim 33 depends form claim 29. The term “plasticizer” is not recited prior to the instant recitation in instant claims 29 or claim 33 and, as such, there is insufficient antecedent basis for this limitation in the claim. It is also unclear whether a plasticizer is or is not present in the composition.
Claim 33 recites the limitation "wherein the pre-determined period of time is based on a variation of one or more of… duration" in lines 1-2 of the claim. The claim is indefinite because it is unclear what duration is being varied.
Claim 34 recites the limitation "type of added co-polymer, and ratio of co-polymer to the active agent" in lines 2-3 of the claim. Claim 34 depends form claim 24. The term “co-polymer” is not recited prior to the instant recitation in instant claims 24 or claim 34 and, as such, there is insufficient antecedent basis for this limitation in the claim. It is also unclear whether a co-polymer is or is not present in the composition.
Claim 34 recites the limitation "wherein the pre-determined period of time is based on a variation of one or more of… duration" in lines 1-2 of the claim. The claim is indefinite because it is unclear what duration is being varied.
Conclusion
All claims have been rejected; no claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY HAGOPIAN whose telephone number is (571)272-6097. The examiner can normally be reached on M-F 9:00 am - 3:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached on 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Casey S. Hagopian
Examiner, Art Unit 1617
/CARLOS A AZPURU/Primary Examiner, Art Unit 1617