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 1-20 are pending.
Priority
Claims 1-20 have priority to PRO 63/522796 filed on June 23, 2023.
Specification
The use of the terms SYLGARD, GlutaMAX, PromoCell, which is a trade name or a mark used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as TM, SM, or following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
It is further noted that the listing of references on pages 51 -52 in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The drawings are objected to because:
Fig. 2(b) is not legible.
Fig. 7 graph is 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.
Additionally, The drawings are objected to because of the following informalities: there is description of color in the Specification of Figure 19 on pg. 8-9 last para. [0059], and the various colors cannot be distinguished from each other since the figures are in black and white.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification: The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee. Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4-19 of copending Application No. 18/924,564 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The claims of the instant application are not patentably distinct from the claims of copending application 18/925,564. Although claim 1 of the instant application recites a substrate having a “low surface energy and/or ultralow adhesion”, and claim 1 of Application 18/925,564 recites a “substantially flat, non-adherent substrate”, the specification s of the two applications are substantively identical and describe the same substrate embodiments, including PDMS, as the substrate used to practice the invention. Applicant previously canceled the “low surface energy” language in Application 18/925,564 and amended claim 1 to recite “non-adherent substrate”, thereby indicating that the amended terminology describes the same disclosed substrate embodiments. Furthermore, the incubation time limitation originally recited in claim 3 of the instant application “wherein the incubation time ranges from 20 minutes to 10 hours” was incorporated into claim 1 after canceling claim 3 of Application 18/925,564 resulting in both applications still requiring the same incubation time range. The only identified difference between the specifications is the inclusion in Application 18/925,564 of a paragraph relating to the electronically submitted sequence listing which does not affect the disclosed invention [See ¶ 0002 of App. 18/925,564]. Additionally, claims 2 and 4-19 of the instant application are identical to claims 2 and 4-19 of Application 18/925,564. Based on this, and when read in light of the identical disclosures of the respective specifications and disclosure of a substantially flat substrate, i.e. PDMS, the claims of the instant application and Application 18/925,564 are directed to the same invention and substantially identical claim scopes.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Objections
Claim 1 is objected to for the following reasons:
Claim 1 recites “culture medium on to a substantially flat substrate” should read “culture medium onto
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 20 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a cell sheet without significantly more. The claim(s) recite(s) cell sheet which is not shown to be different from that in nature.
The Office published Office's new guidance document entitled 2019 Revised Patent Subject Matter Eligibility Guidance, published January 7, 2019. Applicant is directed to the Federal Register, Volume 4, No. 4, pages 50-57 at page 74621.
Step 1 of the USPTO' S eligibility analysis entails considering whether the claimed subject matter falls within the four statutory categories of patentable subject matter identified by 35 U.S.C. 101: Process, machine, manufacture, or composition of matter. The claims are directed to a composition of matter (Step 1, YES). Step 2A of the 2019 Revised Patent Subject Matter Eligibility Guidance is a two-prong inquiry. In Step 2A Prong One, examiners evaluate whether the claim recites a judicial exception. The composition of matter (cell sheet) is directed to a natural phenomenon (Step 2A, prong 1, Yes). Because the claim recites a nature-based product limitation (cell sheet), the markedly different characteristics analysis is used to determine if the nature-based product limitation is a product of nature exception. The claim also recites "made according to the method of claim 1" and "where in the cell sheet is an artificial meat product or is for wound healing, regenerative medicine or drug discovery applications". The markedly different characteristics analysis is performed by comparing the nature-based product limitation in the claim to its naturally occurring counterpart to determine if it has markedly different characteristics from the counterpart. Here, the closest natural counterpart is naturally occurring cell sheet as Wei (Wei, Qi, et. al. Tissue Engineering Part A 20.11-12 (2014): 1703-1714.) teaches the blastoderm exists as a naturally occurring cell sheet (page 1703, left col.). When the claimed cell sheet is compared to this counterpart, the comparison indicates that there are no differences in structure, function or other characteristics. The claimed cell sheet is not markedly different from the natural counterpart as a result of the method of production or its intended use because the method does not imbue any markedly different characteristics to the cell sheet and because Applicant's specification discloses that the cell sheets mimic natural tissue compositions (page 17, para. 00106. Therefore, the claimed cell sheet is a product of nature exception and recites a judicial exception. In Step 2A Prong Two, examiners evaluate whether the claim recites additional elements that integrate the exception into a practical application of that exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. Besides the judicial exception, the claim recites the judicial exception is made according to the method of claim 1 intended use as an artificial meat product or for wound healing, regenerative medicine or drug discovery applications. An evaluation of whether this limitation is insignificant extra-solution activity is then performed. Note that because Step 2A Prong Two analysis excludes consideration of whether a limitation is well-understood, routine, conventional activity, this evaluation does not take into account whether or not the limitation is well-known. When so evaluated, these additional elements are insignificant extra-solution activity because the judicial exception is recited so generically, the elements recite product-by-process and intended use which do not limit the product, a naturally occurring cell sheet. The claim does not recite how the cell sheet is different from a naturally occurring cell sheet due to the production method or for intended use as a meat product or wound healing or regenerative medicine or in drug discovery. Therefore, these elements fail to meaningfully limit the claim because it is at best the equivalent of merely adding the words "apply it" to the judicial exception. Accordingly, the dressing material does not integrate the recited judicial exception into a practical application and the claim is therefore directed to the judicial exception (Step 2A, prong 2, NO). In Step 2B, the eligibility analysis evaluates whether the claim as a whole amount to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements adds an inventive concept into the claim. As discussed with respect to Step 2A Prong Two, the claim recites a product-by-process and intended use of the product, which is at best the equivalent of merely adding the words "apply it" to the judicial exception. Mere instructions to apply an exception cannot provide an inventive concept. At Step 2B, the evaluation of the insignificant extra solution activity consideration takes into account whether or not the extra-solution activity is well known. Here, recitation of the intended uses of the cell sheet is recited at a high level of generality. Thus, recitation of these additional elements do not amount to significantly more and does not provide an inventive concept (Step 2B: No). Markedly different characteristics can be expressed as the product's structure, function, and/or other properties. In accordance with this analysis, a product that is purified or isolated, for example, will be eligible when there is a resultant change in characteristics sufficient to show a marked difference from the product's naturally occurring counterpart. If the claim recites a nature-based product limitation that does not exhibit markedly different characteristics, the claim is directed to a "product of nature" exception (a law of nature or naturally occurring phenomenon), and the claim will require further analysis to determine eligibility based on whether additional elements add significantly more to the exception. Limitations that were found not to be enough to qualify as "significantly more" when recited in a claim with a judicial exception include: Adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer; simply appending well understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry; adding insignificant extra solution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea; or generally linking the use of the judicial exception to a particular technological environment or field of use. In the instant case, the limitations of the claim does not impose limits on the claim scope such that they are not markedly different in structure from a naturally occurring product.
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 1-19 are rejected under 35 U.S.C. §103 as being unpatentable in view of Miura and Fujimoto (Hereinafter Miura) [Formation and recovery of a cell sheet by a particle monolayer with the surface roughness, Colloids and Surfaces B: Bioinformatics, 2008], in view of Haraguchi et al. [Fabrication of functional three-dimensional tissues by stacking cell sheets in vitro, Nature Protocols, 2012], in view of Chae and Lee (Hereinafter Chae) [Monolayer/spheroid co-culture of cells on a PDMS well plate mediated by selective polydopamine coating, Journal of Materials Chemistry B, 2020], in view of Javaherian et al. [A fast and accessable methodology for micro-patterning cells on standard culture substrates using parafilm inserts, PLos One, 2011], in view of Sigma [Parafilm M Product Information, 2020].
For claim 1, Miura teaches a method of forming a cell sheet, comprising: seeding cells with a culture medium on a substantially flat substrate [Abstract], the substrate have low surface energy and/or ultralow adhesion [2.4 Cell detachment and adhesion of a cell sheet ¶ 1]; and incubating cells on the substrate under time and temperature conditions to form a cell sheet [2.2 Preparation of particles and particle monolayers]; wherein the cells are seed on the substrate to a monolayer density of at least 65% [Abstract]. Although Miura does not specifically cite a percentage for monolayer density, the abstract does cite “Human umbilical vein endothelial cells…were seeded at a high density”. Given this, a person of ordinary skill would understand this to mean at least 65% or greater.
For claim 2 where the cells are seeded on the substrate to a monolayer density of 90 to 100%, again, Miura discloses that the human umbilical vein endothelial cells were seeded at a high density. A person of ordinary skill would understand this to include 90 to 100% given this range would fall under “seeded at a high density” [Abstract].
For claim 3 where the incubation time ranges from 20 minutes to 10 hours, Miura teaches an incubation range within Applicant’s cited limitation [2.2 Preparation of particles and particle monolayers].
For claim 4 where the incubation temperature ranges from 25˚C to 39˚C, Miura teaches that the cells were incubated in an endothelial growth medium at 37˚ C in an atmosphere of humidified air containing 5% CO2 [2.3 Cell Culture].
For claim 5 where the cell sheet is a 3-dimensional sheet, Haraguchi et al., discussing fabrication of 3D tissue derived from 2D cell sheets, teaches a method for fabricating 3D tissues cell sheets derived from 2D cell sheets through the means of stacking [Fig. 1]. Here, it would have been prima facie obvious to a person of ordinary skill in the art to modify the systems and methods of Miura that discussed creating cell sheets using high density cell seeding on low adhesive flat surfaces with the additional teachings of Haraguchi et al. that disclosed a method for creating 3D cell sheets from 2D (monolayer) cell sheets through the means of stacking. Because of this, there is a reasonable expectation of success that a person of ordinary skill, based on the teachings of both Miura and Haraguchi et al., would have been able culture monolayered cell sheets on low adhesive flat surfaces that could then be used to create 3D cell sheets.
For claim 6 where the cells were seeded to a mold, Miura discusses that it is known that cell shape orientation are strongly influenced by surface topography such as convexes, concaves, pores, ridges, and grooves due to contact guidance [Introduction ¶ 2]. Miura further disclosed fabricating a two-dimensional colloidal array with topographical roughness [Id.].
For claim 7 where the substantially flat substrate comprises at least one topographical feature, Miura et al. discloses topographical features, i.e. roughness [Abstract].
For claims 8 and 9 where the flat substrate can be from the group consisting of silicone polymer, fluoropolymer, passivated or native polyolefin, denser than water liquid, or a combination thereof, and the silicone polymer is PDMS, Chae, discussing monolayer co-cultured cells on PDMS, teaches PDMS is non-adherent to cells and was used in both monolayer culturing and spheroid co-cultures [Abstract, Introduction ¶ 3, and Fig. 1]. Furthermore, there is a reasonable expectation of success that a person of ordinary skill would recognize the teachings of Miura for a method of seeding cells on a non-adhesive or ultralow adhesive flat surface for culturing cell sheets with the teachings of Chae who taught that PDMS is a non-adhesive substrate that can be successfully used in monolayer cell cultures. Given this, 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 Miura that discusses methods for creating cellular sheets by culturing cells on a flat ultralow adhesive substrate with the additional teachings of Chae where it teaches the use of PDMS a non-adhesive substrate that can be used in monolayer culturing of cells.
For claim 10 where the cells are human cells or animal cells, Miura, as well as Haraguchi et al. and Chae, teach using human derived cells that include human umbilical vein endothelial cells, human cardiac stem cells, and mesenchymal stem cells, respectively [Abstract, Abstract, and Abstract].
For claims 11-13 where two or more cells are seeded and incubated, are divided by an insert on the substrate, and the insert has a thickness ranging from 0.1 mm to 10 mm, Javaherian et al., discussing co-cultures using Parafilm inserts, teaches co-cultured cell patterns where two different cell types are seeded at different areas of a glass substrate that is divided by a parafilm insert [Fig. 1, Fig. 3]. Additionally, Sigma discloses that Parafilm M has a thickness of 0.13 mm in thickness [Product description].
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 Miura that disclosed a method of forming cell sheets described in Applicant’s claim 1 with the further teachings of Javaherian et al. where the authors disclosed co-culturing on the same substrate divided by a Parafilm M insert that had a thickness of 0.13 mm, and was subsequently incubated for a period [Cells seeding into the patterns, Sigma, respectively]. Therefore, there is a reasonable expectation of success that a person of ordinary skill would know to combine the teachings of Miura with the additional teachings of both Javaherian et al. and Sigma in order to create a co-culture cell sheet on an ultralow adhesive flat substrate where the co-cultured cells are dived by a thin insert such as Parafilm M.
For claim where the insert is used to segment the substrate area for selective cells and is removed within 10 minutes to 1 hour after seeding, Javaherian et al. further teaches that seeding the first cell type and then seeding the second cell type followed by an incubation period of 1 hour. Javaherian et al. further discloses the Parafilm can removed at any desired time point [pg. 4, right column ¶ 3, pg. 7 left column ¶ 3].
For claim 15 where the culture medium is selected from the group consisting of a biological media, etc., Miura teaches the use of a biological medium [2.3 Cell culture].
For claim 16 where the cell sheets mutually fuse under time and temperature conditions, Haraguchi et al. teaches that two cell sheets, e.g. cardiac cell sheets, were capable of synchronizing rapidly and without arrhythmias after layering. Haraguchi et al. further disclosed after successful graft, the implanted cell sheets grew in accordance with host growth, developed electrical and functional couplings between the implanted tissue and host heart [Anticipated results ¶ 1].
For claims 17-19 where the stacked cell sheets fused within a time range of 10 minutes to 10 hours and the temperature ranged from 25˚ C to 39˚C, the edges mutually fuse under time and temperature, and the temperature range is the same as what is listed in claim 17, Haraguchi et al. teaches to incubate the cell layers at 37˚ C for 30-60 minutes to promote adhesion between the two cell sheets [Troubleshooting parts V and VI]. Although Haraguchi et al. does not specifically state the overlap fuses under time and temperature, a person of ordinary skill would interpret the teachings of Haraguchi et al. that complete adhesion takes place between the multiple cell sheets during the incubation period at the recommended times and temperatures that are within the ranges listed in Applicant’s claims. Therefore, it would have been prima facie obvious to a person skill in the art prior to the filing of the claimed invention to modify the systems and methods of Miura that teaches a method for culturing cell sheets using a flat substrate with the additional teachings of Haraguchi et al. that discloses that the 2D monolayer cell sheets can be layered, incubated at a given temperature for a specified time resulting in adhesion, i.e. fusing, between the cell sheet layers. And since this adhesion takes place within the specified ranges listed in Applicant’s claims 17 and 19, there is a reasonable expectation of success that person of ordinary skill would be able to combine these teachings in order to produce a 3D cellular construct derived from 2D monolayers cellular sheets cultured on ultralow to non-adherent flat surfaces where the stacked cellular sheets could further be incubated at specified temperatures for a specified length of time to allow the stacked cellular sheets to adhere to each other resulting in a 3D cellular construct.
For claim 20 where the cell sheet is artificial meat, a product for wound healing, or regenerative medicine, etc., Haraguchi et al. discloses the use of the 3D cellular constructs for cardiac repair [Anticipated results]. Therefore, it would have been prima facie obvious to a person of ordinary skill to further recognize the teachings of Haraguchi et al. where the authors disclose the purpose of the 3D cellular construct is use in regenerative medicine given that the researchers were able to successfully graft the 3D cellular construct derived from 2D cardiac cell sheets onto a rat heart where the 3D cellular construct graft was able to obtain functional couplings between the implanted tissue and host hear. Given this, there is a reasonable expectation of success that a person of ordinary skill would recognize the teachings of both Miura and Haraguchi et al. in order to develop a 3D cellular construct derived from 2D cell sheets cultured on ultralow or non-adherent flat surfaces, i.e. substrates, where the 2D cell sheets are then stacked, incubated for specific times at specific temperatures to further promote adhesion between the layered cell sheets, and then use these 3D cellular constructs in for such things as regenerative medicine.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN DAVID MOORE whose telephone number is (703)756-1887. The examiner can normally be reached M-F 8-5.
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/JOHN DAVID MOORE/Examiner, Art Unit 1638
/Tracy Vivlemore/ Supervisory Primary Examiner, Art Unit 1638
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